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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07876076




Registration number
Help: Registration number
NCT07876076
Ethics application status
Help: Ethics application status
Date submitted
Help: Date submitted
2/10/2026
Date registered
Help: Date registered
15/10/2026
Date last updated
Help: Date last updated
5/11/2026

Titles & IDs
Public title
A Study of Single and Multiple Subcutaneous or Intravenous Doses of ADX-001 in Healthy Adults to Assess Safety, Effects, and Immune Response
Scientific title
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of Subcutaneous and Intravenous ADX-001 in Healthy Adult Participants
Additional trial identifiers [1] 0 0
ADX-001-CLN-01
Universal Trial Number (UTN)
Trial acronym
Related trial records

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

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Treatment: Drugs - ADX-001
Treatment: Drugs - ADX-001
Treatment: Drugs - Placebo

Experimental: SAD Cohort 1-5 -

Experimental: MAD Cohort 6-9 -


Treatment: Drugs: ADX-001
ADX-001 administered as a single dose according to the assigned cohort and route of administration (SC or IV).

Treatment: Drugs: ADX-001
ADX-001 administered every 4 weeks (Q4W) for a total of 4 doses according to the assigned cohort and route of administration (SC or IV).

Treatment: Drugs: Placebo
Matching placebo administered by SC injection or IV infusion according to the route and dosing schedule of the assigned cohort.
Intervention code [1] 0 0
Treatment: Drugs
Description of the comparator or control
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and severity of Treatment Emergent Adverse Events (TEAEs) of single and multiple doses of ADX-001 administered by subcutaneous and intravenous injection
Timepoint [1] 0 0
From first dose through Day 365 for participants receiving a single dose and through Day 505 for participants receiving multiple doses.
Secondary outcome [1] 0 0
PK Parameters peak concentration (Cmax) - SAD
Timepoint [1] 0 0
Pre-dose on Day 1 through Day 365
Secondary outcome [2] 0 0
PK Parameters peak concentration (Cmax) - MAD
Timepoint [2] 0 0
Pre-dose on Day 1 through Day 87
Secondary outcome [3] 0 0
Area under the concentration-time curve (AUC0-t) - SAD
Timepoint [3] 0 0
Pre-dose on Day 1 through Day 365
Secondary outcome [4] 0 0
Area under the concentration-time curve (AUC0-t) - MAD
Timepoint [4] 0 0
Pre-dose on Day 1 through Day 87
Secondary outcome [5] 0 0
Terminal elimination half-life (t1/2) - SAD
Timepoint [5] 0 0
Pre-dose on Day 1 through Day 365
Secondary outcome [6] 0 0
Terminal elimination half-life (t1/2) - MAD
Timepoint [6] 0 0
Pre-dose on Day 1 through Day 87
Secondary outcome [7] 0 0
Clearance (CL) - SAD
Timepoint [7] 0 0
Pre-dose on Day 1 through Day 365
Secondary outcome [8] 0 0
Clearance (CL) - MAD
Timepoint [8] 0 0
Pre-dose on Day 1 through Day 87
Secondary outcome [9] 0 0
Volume of distribution (Vz) - SAD
Timepoint [9] 0 0
Pre-dose on Day 1 through Day 365
Secondary outcome [10] 0 0
Volume of distribution (Vz) - MAD
Timepoint [10] 0 0
Pre-dose on Day 1 through Day 87
Secondary outcome [11] 0 0
Serum concentrations of free CD22L- SAD
Timepoint [11] 0 0
Pre-dose on Day 1 through Day 365
Secondary outcome [12] 0 0
Serum concentrations of free CD22L- MAD
Timepoint [12] 0 0
Pre-dose on Day 1 through Day 87
Secondary outcome [13] 0 0
Incidence of treatment-emergent anti-drug antibodies (ADA)
Timepoint [13] 0 0
From Day 14 through Day 112 after a single dose, and through 56 days after the final dose following multiple doses
Secondary outcome [14] 0 0
Maximum observed serum concentration (Cmax) of ADX-001 by ADA status
Timepoint [14] 0 0
From Day 14 through Day 112 after a single dose, and through 56 days after the final dose following multiple doses
Secondary outcome [15] 0 0
Minimum observed serum concentration (Cmin) of ADX-001 by ADA status
Timepoint [15] 0 0
From Day 14 through Day 112 after a single dose, and through 56 days after the final dose following multiple doses
Secondary outcome [16] 0 0
Area under the serum concentration-time curve (AUC0-last) of ADX-001 by ADA status
Timepoint [16] 0 0
From Day 14 through Day 112 after a single dose, and through 56 days after the final dose following multiple doses
Secondary outcome [17] 0 0
Area under the serum concentration-time curve over the dosing interval (AUCt) of ADX-001 by ADA status
Timepoint [17] 0 0
From Day 14 through Day 112 after a single dose, and through 56 days after the final dose following multiple doses
Secondary outcome [18] 0 0
Clearance (CL) of ADX-001 by ADA status
Timepoint [18] 0 0
From Day 14 through Day 112 after a single dose, and through 56 days after the final dose following multiple doses
Secondary outcome [19] 0 0
Terminal elimination half-life (t½) of ADX-001 by ADA status
Timepoint [19] 0 0
From Day 14 through Day 112 after a single dose, and through 56 days after the final dose following multiple doses
Secondary outcome [20] 0 0
Incidence of treatment-emergent adverse events by ADA status
Timepoint [20] 0 0
From Day 14 through Day 112 after a single dose, and through 56 days after the final dose following multiple doses

Eligibility
Key inclusion criteria
* Provide informed consent - Be willing and able to sign a consent form after understanding the study and before any study-related procedures are performed.
* Age - Be a healthy adult male or female aged 18 to 55 years.
* Body weight and BMI - Have a Body Mass Index (BMI) between 18.0 and 32.0 kg/m². Weigh more than 50 kg and less than 120 kg.
* For women who can become pregnant - Have a negative pregnancy test before participating.
* Use highly effective birth control during the study and for 15 months after the last study dose.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
You cannot participate in this study if any of the following apply to you:

1. Medical Conditions

* You have a serious or ongoing health condition affecting the heart, lungs, liver, kidneys, digestive system, hormones, nervous system, immune system, or mental health.
* You have a history of severe allergic reactions, anaphylaxis, or are allergic to the study drug or its ingredients.
2. Infections

* You test positive for HIV, hepatitis B, or hepatitis C.
* You have tuberculosis (TB), a history of TB, recent close contact with someone who has active TB, or a positive TB screening test.
* You test positive for COVID-19 before receiving the study drug.
* You have an active or long-term infection requiring treatment.
* You have needed antibiotics or other anti-infective treatment within the last month.
* You were hospitalized or required intravenous (IV) treatment for an infection within the last 3 months.
* You have a history of certain recurring infections, such as shingles (herpes zoster).
* You have a fever higher than 37.7°C during screening or within 7 days before dosing.
* In some cases, minor abnormalities may be accepted if the study doctor considers them not clinically important.

4. Heart and Blood Pressure Problems 5. Previous Medications or Treatments

* You have previously received medicines that target TNFa or IL-23.
* You have received other biologic medicines within the last 6 months.
* You have used medicines that significantly suppress the immune system within the required washout period.
* You have recently used prescription or over-the-counter medications that could affect study results.
* You received a live vaccine within the last 12 weeks or any other vaccine within the last 4 weeks.
* You donated blood, plasma, or platelets too recently before joining the study.

6. Alcohol or Drug Use. 7. Pregnancy and Reproductive Considerations
* You are pregnant, breastfeeding, or planning to become pregnant during the study period.
* You are unwilling to use the required birth control methods.

8. Participation in Other Research Studies
* You have recently participated in another clinical trial involving an investigational drug or device.
* You have previously participated in this study.

9. Ability to Participate
* You are unable to understand the study requirements or provide informed consent.
* You are unable or unwilling to follow study procedures and visit schedules.

10. Conflict of Interest
* You are an employee of the study sponsor or investigator, or an immediate family member of one.

11. Other Safety Concerns
* The study doctor believes that participating could put your health at risk, prevent you from completing the study, or affect the reliability of the study results.

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
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/10/2026
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
14/12/2028
Actual
Sample size
Target
88
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX Clinical Research - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Adaxion Therapeutics
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
Andrew Miller
Address 0 0
Country 0 0
Phone 0 0
+1-858-224-7766
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


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/NCT07876076