Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625001006437p
Ethics application status
Submitted, not yet approved
Date submitted
25/08/2025
Date registered
10/09/2025
Date last updated
10/09/2025
Date data sharing statement initially provided
10/09/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 1, randomized, double-blind, placebo-controlled study to investigate the safety, tolerability and pharmacokinetics of intravenously infused IB409 in healthy adult participants
Scientific title
A Phase 1, randomized, double-blind, placebo-controlled study to investigate the safety, tolerability and pharmacokinetics of intravenously infused IB409 in healthy adult participants
Secondary ID [1] 315122 0
IB409-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myocardial Infarction 338539 0
Condition category
Condition code
Cardiovascular 334845 334845 0 0
Coronary heart disease
Emergency medicine 334854 334854 0 0
Other emergency care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a study of safety, tolerability and pharmacokinetics of a single ascending dose of IB409-001 in healthy volunteer participants. It is cohort designed with up to 6 cohorts of eight participants each, where 6 will receive IB409 and two will receive placebo as an intravenous injection. The dose escalation decisions between cohorts will be managed by a Safety Monitoring Committee (SMC).
Eligibility will be assessed during a screening period of up to 28 days prior to dosing. For the treatment period, subjects will be admitted to the clinical research unit (CRU) one day prior to the dosing (Day -1). Randomisation will occur on the morning of dosing (Day 1).
On Day 1, all subjects will receive an intravenous dose of IB409 or placebo. Participants will be discharged from the clinic on Day 3 after all required study procedures are completed and if deemed medically fit. Subjects will then return to the clinic on Day 7 (+1 day), on Day 15 (±1 day) for follow up visits and finally for an End of Study visit on Day 30 (±2 days).
Up to 6 cohorts may be enrolled in the study. Five (5) single doses are planned to be tested in 5 cohorts (Cohort A1 to Cohort A5) of up to 8 healthy volunteers (up to 6 active and 2 placebo). An additional ascending dose level (Cohort A6), also consisting of up to 8 subjects (up to 6 active and 2 placebo), will be enrolled based on emerging safety, tolerability, and PK data. Additional cohorts may also be enrolled if deemed necessary by the SMC and Sponsor.
The planned IB409 starting dose for this study is 0.02 mg per kg, administered as a single IV infusion over 40 minutes (± 10 minutes). All doses will be administered in clinic under the direct supervision of qualified study nurses and doctors.
The anticipated dose range of IB409 for investigation in this study is 0.02 mg per kg up to 1.0 mg per kg.

The following dose levels are currently planned for the study:
• Cohort A1: 0.02 mg per kg IB409 or placebo
• Cohort A2: 0.05 mg per kg IB409 or placebo
• Cohort A3: 0.15 mg per kg IB409 or placebo
• Cohort A4: TBD mg per kg IB409 or placebo
• Cohort A5: TBD mg per kg IB409 or placebo
Optional Cohort A6: TBD mg per kg IB409 or placebo
Note: Currently, doses are confirmed for only the first 3 cohorts (A1 to A3), and the dose from cohorts A4 to A6 will be determined based on SMC review of cumulative SAD cohort safety and PK data of all previous cohorts.
The highest dose that may be evaluated is 1.0 mg per kg of IB409.

Sentinels will be used in all cohorts. Within each cohort, 2 subjects will be treated first: 1 subject will receive IB409 and 1 subject will receive placebo. Provided no clinically significant safety issues, are noted at least in the 48 hours following the sentinels’ dosing, as judged by the Principal Investigator (PI) in consultation with the local medical monitor (MM) and Sponsor, if required, the remaining 6 subjects of the cohort can be dosed (5 active, 1 placebo).

Safety Oversight : The study will be subject to oversight by an SMC comprised of the Principal Investigator (PI), independent local MM, and Sponsor medical representative as core members.
The SMC will convene for each SAD dosing cohort to determine if dose escalation may proceed based on review of cumulative (blinded) data. Data from participants receiving placebo and active treatment will be considered in the dose escalation discussion.
The dose escalation decision will be based upon the nature, severity and frequency of any safety and/or tolerability observations (up to and including the Day 7 visit), and the available PK data.
The SMC may also pause the study to conduct an expert review and determine next steps.
No intra-cohort dose escalation is permitted.
Intervention code [1] 331745 0
Treatment: Drugs
Comparator / control treatment
This study is placebo controlled.
Each dose cohort will have a total of eight (8) participants. Of these, two will receive placebo. The placebo is Normal Saline (0.9% sodium chloride) for injection.
Control group
Placebo

Outcomes
Primary outcome [1] 342484 0
To investigate the safety and tolerability of IB409 of a single dose administered intravenously
Timepoint [1] 342484 0
- Adverse event data will be collected from the time of consent until the last study visit (Day 30 ± 2 days post-infusion). - Safety Laboratory Tests (hematology, serum chemistry, coagulation, urinalysis) are collected at Screening, Day -1, Day 1, Day 2, Day 3, Day 7 (+1 day post-infusion), Day 15 (± 1 day post-infusion) and last study visit Day 30 (± 2 days post-infusion) or early termination visit. - Vital signs assessments will be conducted at Screening, Day -1, Day 1, Day 2, Day 3, Day 7 (+1 day post-infusion), Day 15 (± 1 day post-infusion) and last study visit Day 30 (± 2 days post-infusion) or early termination visit. - ECG Data will be collected at Screening, Day -1, Day 1 pre-dose (within 1 hour prior to start of dosing) and at 20 and 40 minutes, and at 1, 4, 6, 12 hours, and at 24 hours (Day 2), and 48 hours (Day 3) after the start of infusion, and at the Follow up visits on Day 7 (+ 1 post-infusion), and at the last study visit on Day 30 (± 2 days post-infusion) or early termination visit. . - Telemetry monitoring will be performed from at least 1 hour prior to dosing until at least 6 hours after the end of the infusion on Day 1 only - Infusion site reaction assessments will be undertaken prior to dosing on Day 1 (within 1 hour) to establish a baseline, then as soon as possible after the end of infusion and at approximately 2, 4, and 24 hours (Day 2) post start of infusion. A window of ± 10 minutes will be permitted for these infusion site assessment timepoints. Infusion site reaction assessments will also be performed on Day 3 prior to discharge from the CRU, and at the Follow-up visit on Day 7 (+ 1 day post-infusion).
Secondary outcome [1] 451026 0
To investigate the pharmacokinetic (PK) characteristics of IB409 in plasma of a single dose administered intravenously
Timepoint [1] 451026 0
Blood samples for PK analysis will be collected pre-dose (within 2 hours of start of the infusion) and at 0.25 h ± 1 min, 0.5 h± 1 min, 0.67 h ± 1 min, 0.75 h ± 1 min, 1 h ± 5 min, 1.25 h ± 5 min, 1.5 h ± 5 min, 1.75 h ± 5 min, 2 h ± 5 min, 4 h ± 10 min, 6 h ± 10 min, 8 h ± 10 min, 12 h ± 10 min, 24 h ± 60 min (Day 2), and 48 h ± 60 min (Day 3) after the start of infusion. PK samples will also be collected during the Follow up visit on Day 7 (+1 day).
Secondary outcome [2] 451027 0
Exploratory: To conduct a preliminary evaluation of tissue injury biomarkers (pharmacodynamics) in serum after a single dose of IB409 administered intravenously
Timepoint [2] 451027 0
Blood serum samples for Biomarkers will be collected pre-dose (within 2 hours of start of the infusion) on Day 1 and at 24 h ± 60 min (Day 2), and 48 h ± 60 min (Day 3) after the start of infusion. Biomarker samples will also be collected during the Follow up visits on Day 7 (+1 day), Day 15 (± 1 day) and the last study visit Day 30 (± 2 days).
Secondary outcome [3] 451028 0
Exploratory: To investigate and determine the presence of antibodies that bind to IB409 for the Sponsor's future clinical development program
Timepoint [3] 451028 0
Blood serum samples for ADA assessments will be collected pre-dose (within 2 hours of start of the infusion) on Day 1 and during the Follow up visits on Day 7 (+1 day), Day 15 (± 1 day) and the last study visit Day 30 (± 2 days).

Eligibility
Key inclusion criteria
1. Male or female participants aged between 18 and 65 years of age, inclusive at the time of signing the informed consent document.
2. Body weight greater than or equal to 45 kg and body mass index (BMI) within the range of 18 to 32 kg per m2 inclusive at screening.
3. Are medically healthy without clinically significant abnormalities (in the opinion of the PI or qualified designee) at screening and at time of CRU admission on Day -1, as applicable, including:
a. Physical examination without any clinically relevant findings at the discretion of the PI (or qualified designee);
b. Systolic blood pressure in the range of 90 to 140 mmHg and diastolic blood pressure in the range of 40 to 90 mmHg as measured after at least 5 minutes in a supine position;
c. Heart rate (HR) in the range of 40 to 100 bpm as measured after at least 5 minutes rest in a supine position;
d. Body temperature (tympanic), between 35.5 degrees Celsius and 37.5 degrees Celsius;
e. No clinically significant findings at the discretion of the PI (or qualified designee) in clinical chemistry, hematology, coagulation and urinalysis tests;
f. Triplicate 12-lead ECG (average of 3 readings), taken after at least 5 minutes in a supine position, with a QT interval corrected using the Fridericia method (QTcF) less than or equal to 450 msec for males and less than or equal to 470 msec for females and no clinically significant abnormalities as judged by the PI (or qualified designee).
Note: If any results fall outside the reference range and are considered potentially clinically significant, repeat testing may be performed at the PI’s discretion.
4. Females must be non-pregnant and non-lactating, or must be
a. Surgically sterile (e.g., hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before screening), or
b. Use highly effective contraceptive method (oral contraceptive pills [OCPs], long-acting implantable hormones, injectable hormones, a vaginal ring or an intrauterine device [IUD]) or intrauterine hormone-releasing system (IUS) used for at least 4 weeks prior to screening, and condom for male partner from screening until study completion, including the follow up period for at least 30 days after the administration of study drug, or
c. Post-menopausal for greater than or equal to 12 months. Post-menopausal status will be confirmed through testing of follicle-stimulating hormone (FSH) levels (greater than 40 IU per L) at screening for amenorrheic female participants. Female participants whose only partner has had a vasectomy must agree to use a condom for the male partner from screening until study completion, including the follow up period for at least 30 days after the administration of study drug, or
d. Female participants who are abstinent from heterosexual intercourse as part of their usual lifestyle will also be eligible for participation.
Note: Tubal occlusion is considered a highly effective form of contraception (and not a method of surgical sterilization), thus use of a condom by a male partner is also required, from screening until study completion, including the follow up period for at least 30 days after the administration of study drug.
5. Women of childbearing potential (WOCBP) must agree to abstain from egg donation through 30 days after administration of study drug.
6. Males must be:
a. Surgically sterile (greater than 90 days since vasectomy with documentation of azoospermia 90 days after procedure) and agree to use a condom from screening until study completion, including the follow up period for at least 90 days after the administration of study drug, or
b. Abstinent from heterosexual intercourse as part of their usual lifestyle, or
c. If engaged in sexual relations with a WOCBP, the female partner of male participant must either be surgically sterile (e.g., hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or,
d. Use an acceptable, highly effective contraceptive method from screening until study completion, including the follow up period, for at least 90 days after the administration of study drug. Acceptable methods of contraception include simultaneous use of condoms and effective contraceptive for the female partner (WOCBP) that includes: OCPs, long-acting implantable hormones, injectable hormones, a vaginal ring or an IUD used for at least 4 weeks prior to screening.
7. Male participants must agree to refrain from donating sperm from screening until study completion, including the follow up period, for at least 90 days after the administration of study drug.
8. Ability and willingness to comply with all protocol procedures and restrictions (e.g., compliance with visit schedule, alcohol restrictions, etc.).
9. Ability to provide written informed consent.
Note: Participants with mild asthma that is controlled with occasional use of a rescue inhaler (no chronic therapy or inhaled corticosteroids) and those with mild atopic dermatitis managed with use of topical emollients only (no topical corticosteroids) may be considered for study participation.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Regular smokers (more than 2 cigarettes per day, or more than 10 cigarettes per week, or the equivalent).
2. Known hypersensitivity, allergy, or intolerance to the study intervention, or any of the excipients contained in the intervention formulation. If any history of anaphylaxis or infusion reaction to other agents, discussion with (and approval by) the PI, Medical Monitor and Sponsor is required.
3. Any concomitant disease, condition or treatment which according to the PI (or qualified designee), places the participant at unacceptable risk if they were to participate in the study or may confound the ability to interpret data from the study.
4. The participant has a medical history of, or a positive blood test for, human immunodeficiency virus (HIV; anti-HIV1 and anti-HIV2 antibodies), hepatitis C virus (HCV, anti-HCV antibodies), or hepatitis B surface antigen (HBsAg) at screening.
5. History of immunological or autoimmune disorders, or acquired/congenital immunodeficiency, including autoimmune rheumatic diseases. This also includes any acute infections (including viral infections requiring prescribed medical treatment or isolation) occurring during screening or within 3 months prior to the start of screening.
6. Immunization with any live vaccine within 6 weeks prior to administration of study intervention; or expected to require any live vaccines during the study or within 6 weeks after receiving the study intervention.
7. Acute or febrile illness within 7 days prior to the first dose of study intervention or participants with evidence of active infection.
8. Poorly controlled hypertension defined as: average systolic BP greater than 140 mmHg or diastolic BP greater than 90 mmHg in supine position after 5 minutes of rest, (average of 3 readings at screening and baseline).
9. Abnormal cardiac conditions and ECG detected at screening or Day -1:
a. The Corrected QT interval (QTc) of ECG greater than 450 ms, or any QTc value considered clinically significant by the PI.
b. Sustained (i.e., 3 independent measurements within 30 minutes) heart rate greater than 100 or less than 40 bpm after the participant has been at rest for 5 minutes.
c. Personal history of congenital long QT syndrome or family history of congenital long QT or sudden cardiac death.
10. Evidence of active or suspected cancer, or a history of malignancy within the past 5 years, except for the following cases, that did not require systemic therapy and are considered cured: nonmelanoma skin cancer, or other in situ cancers.
11. Any major surgery within 3 months before screening, or plan to have a surgery during the study period.
12. Use of prescription medications within 14 days or 5 elimination half-lives (whichever is longer) of study intervention administration. Use of herbal remedies within 7 days of study intervention administration. Use of standard OTC medication, prescription hormonal contraception may be allowed per PI discretion. In addition, participants who have been on hormone replacement therapy (HRT) for a period of at least 2 months prior to the start of screening will not be excluded from the study, provided the HRT regimen will remain unchanged during the conduct of the study.
13. Previous participation in a study with an investigational drug or device therapy within 30 days or 5 elimination half-lives if known (whichever is longer) prior to administration of the study drug.
14. History of substance abuse within 6 months prior to admission or a positive drug abuse test result on Screening and Day -1. A suspected false positive result may be verified by re-testing at the discretion of the PI (or qualified designee), with up to 1 false positive result permitted.
15. History of alcohol consumption of greater than 21 units per week for males and greater than 14 units per week for females within 6 months prior to screening. One unit is equivalent to 10 g of alcohol which equals to a half-pint (about 240 mL) of beer, 1 glass (125 mL) of wine or 1 (30 mL) measure of spirits.
16. Positive alcohol breath test at screening and Day -1. An alcohol screen test result may be verified by re-testing at the discretion of the PI (or qualified designee), with up to 1 false positive result permitted.
17. Unwilling to abstain from the consumption of caffeine and/or xanthine containing products (e.g., coffee, tea, chocolate, and caffeine containing sodas, etc.) that may influence metabolism of the drug from 72 hours before administration of study drug on Day 1 through to discharge from the CRU.
18. Unwillingness to refrain from unaccustomed physical activity (e.g., heavy lifting, weight or fitness training) from 72 hours prior to admission on Day -1 through to discharge from the CRU, and in the 24 hours prior to each study visit where safety laboratory samples are scheduled for collection.
19. Consumption of grapefruit, grapefruit juice, star fruit, oranges, orange juice, Seville oranges, within 7 days prior to dosing with study drug and participant is unwilling to abstain from consumption of these products until after the final PK sample collection on Day 7 (+ 1 day).
20. Female participants who are lactating.
21. Pregnant participants (positive serum pregnancy test at the initial screening visit or positive urine pregnancy at D -1 [confirmed by serum test]) or planning to become pregnant within 90 days of screening.
22. Receipt of blood products within 2 months prior to screening; donation (or loss) of 500 mL or more whole blood during the 30 days prior to first dosing, or donation of plasma or platelets during the 7 days prior to first dosing, and/or plan to donate whole blood, plasma or platelets within 4 weeks after the last study related blood draw.
23. The participant is unwilling or unable to follow protocol requirements, including attendance at follow up visit(s), or otherwise unsuitable for study participation in the opinion of the PI.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Once deemed eligible for study participation, the participant will be enrolled and (where applicable) assigned a sequential randomization number based on a randomization schedule generated by the study statistician. The randomization schedule will be provided to the unblinded study pharmacist. Participants will receive a randomization number prior to the infusion of the study drug.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization schedule and corresponding treatment assignment will be generated by the biostatistics department per thier standard operating procedures (SOPs)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/09/2025
Actual
Date of last participant enrolment
Anticipated
30/03/2026
Actual
Date of last data collection
Anticipated
30/04/2026
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 28335 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 44548 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 319699 0
Commercial sector/Industry
Name [1] 319699 0
Infensa Bioscience Pty Ltd
Country [1] 319699 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Infensa Bioscience Pyt Ltd
Address
Country
Australia
Secondary sponsor category [1] 322242 0
None
Name [1] 322242 0
Address [1] 322242 0
Country [1] 322242 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 318256 0
Bellberry Human Research Ethics Committee A
Ethics committee address [1] 318256 0
Ethics committee country [1] 318256 0
Australia
Date submitted for ethics approval [1] 318256 0
13/08/2025
Approval date [1] 318256 0
Ethics approval number [1] 318256 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 143598 0
Dr Philip Ryan
Address 143598 0
Nucelus Network Pty Ltd, Level 5, Burnet Tower, 89 Commercial Rd, Melbourne, Victoria, 3004
Country 143598 0
Australia
Phone 143598 0
+61 438 009 787
Fax 143598 0
Email 143598 0
[email protected]
Contact person for public queries
Name 143599 0
Michael Ankersen
Address 143599 0
Infensa Bioscience Pty Ltd, Level 4, 1 James Place, NORTH SYDNEY, NSW 2060
Country 143599 0
Australia
Phone 143599 0
+61 413 500 557
Fax 143599 0
Email 143599 0
[email protected]
Contact person for scientific queries
Name 143600 0
Michael Ankersen
Address 143600 0
Infensa Bioscience Pty Ltd, Level 4, 1 James Place, NORTH SYDNEY, NSW 2060
Country 143600 0
Australia
Phone 143600 0
+61 413 500 557
Fax 143600 0
Email 143600 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: The sponsor reserves the right to withhold data for the intended purposes outlined in the HREC approved protocol while maintaining compliance with local regulations and ICH GCP.



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

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