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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06999720




Registration number
NCT06999720
Ethics application status
Date submitted
22/05/2025
Date registered
31/05/2025
Date last updated
5/06/2025

Titles & IDs
Public title
Study of HX15001 in Adult Healthy Volunteers.
Scientific title
A Phase I, Randomized, Double-Blinded, Placebo-Controlled, Single Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Pharmacodynamics of HX15001 in Adult Healthy Volunteers.
Secondary ID [1] 0 0
HXN-IMM-001-I
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - HX15001 Cohorts 1
Treatment: Drugs - HX15001 Cohorts 2
Treatment: Drugs - HX15001 Cohorts 3
Treatment: Drugs - HX15001 Cohorts 4
Treatment: Drugs - HX15001 Cohorts 5
Treatment: Drugs - HX15001 Cohorts 6
Treatment: Drugs - HX15001 Cohorts 7
Treatment: Drugs - Placebo

Experimental: HX15001 Cohorts 1 - Subjects will receive single subcutaneous dose of HX 15001 or placebo(2:2)

Experimental: HX15001 Cohorts 2 - Subjects will receive single subcutaneous dose of HX 15001 or placebo(4:2)

Experimental: HX15001 Cohorts 3 - Subjects will receive single subcutaneous dose of HX 15001 or placebo(6:2)

Experimental: HX15001 Cohorts 4 - Subjects will receive single subcutaneous dose of HX 15001 or placebo(6:2)

Experimental: HX15001 Cohorts 5 - Subjects will receive single subcutaneous dose of HX 15001 or placebo(6:2)

Experimental: HX15001 Cohorts 6 - Subjects will receive single intravenous dose of HX 15001 or placebo(2:2)

Experimental: HX15001 Cohorts 7 - Subjects will receive single intravenous dose of HX 15001 or placebo(6:2)

Placebo comparator: Placebo - Matching placebo to the IP per cohort.


Treatment: Drugs: HX15001 Cohorts 1
Dose 1

Treatment: Drugs: HX15001 Cohorts 2
Dose 2

Treatment: Drugs: HX15001 Cohorts 3
Dose 3

Treatment: Drugs: HX15001 Cohorts 4
Dose 4

Treatment: Drugs: HX15001 Cohorts 5
Dose 5

Treatment: Drugs: HX15001 Cohorts 6
Dose 6

Treatment: Drugs: HX15001 Cohorts 7
Dose 7

Treatment: Drugs: Placebo
Participants will receive matching placebo across cohorts 1-7 of the study.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse Events (AEs) and Serious Adverse Events (SAEs) cohort 1-3
Timepoint [1] 0 0
Up to day 113
Primary outcome [2] 0 0
Adverse Events (AEs) and Serious Adverse Events (SAEs) cohort 4-7
Timepoint [2] 0 0
Up to day 141
Secondary outcome [1] 0 0
Cmax
Timepoint [1] 0 0
Up to day 113 (cohort 1-3) Up to day 141 (Cohort 4-7)
Secondary outcome [2] 0 0
Tmax
Timepoint [2] 0 0
Up to day 113 (cohort 1-3) Up to day 141 (Cohort 4-7)
Secondary outcome [3] 0 0
t1/2
Timepoint [3] 0 0
Up to day 113 (cohort 1-3) Up to day 141 (Cohort 4-7)
Secondary outcome [4] 0 0
AUC
Timepoint [4] 0 0
Up to day 113 (cohort 1-3) Up to day 141 (Cohort 4-7)
Secondary outcome [5] 0 0
ADA
Timepoint [5] 0 0
Up to day 113 (cohort 1-3) Up to day 141 (Cohort 4-7)

Eligibility
Key inclusion criteria
1. An informed consent document signed and dated by the subject.
2. Healthy male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive.
3. Have a Body mass index (BMI) of 18-32 kg/m2 , inclusive; with body weight =50 kg during the screening.
4. In good health, as determined by the investigator at Screening procedures, with no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations.
5. Subjects must be willing to understand and comply with all research procedures and restrictions, and able to communicate effectively with researchers.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Females who are pregnant, planning to become pregnant, or breastfeeding during the trial.
2. Has a positive result of pregnancy test at Screening or Baseline
3. History of HIV infection, hepatitis B, hepatitis C or syphilis; positive testing for HIV, hepatitis B, HCV Ab or serological reaction of syphilis
4. Subjects at risk for tuberculosis (TB).
5. Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol;
6. Has received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 30 days or 5 half-lives prior to dosing, or plan to receive another experimental agent during the duration of this trial;
7. Subjects who have donated blood (excluding plasma donations) of approximately 1 pint (500 mL) or more within 30 days prior to dosing, or those who plan to donate blood during the study period or within 30 days after the end of the study;
8. Use of prescription or over-the-counter drugs or dietary or herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to dosing
9. Triplicate 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
10. Has clinically significant interventional therapies (surgery, paracentesis, etc.) within 6 months prior to dosing, or plan to have any surgeries during the duration the trial.
11. History of any hypersensitivity or allergic reaction to drugs;
12. Has any other conditions that would, in the opinion of the investigator, put the subjects at increased risk for participation in this trial

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
10/06/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2026
Actual
Sample size
Target
46
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Q-Pharm Pty Ltd. - Herston
Recruitment postcode(s) [1] 0 0
4006 - Herston

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Helixon Biotechnology (Suzhou) Co., Ltd
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Tong Gang
Address 0 0
Country 0 0
Phone 0 0
(86)13918569690
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06999720