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HealthyPhase 1NCT07876076

A Study of Single and Multiple Subcutaneous or Intravenous Doses of ADX-001 in Healthy Adults to Assess Safety, Effects, and Immune Response

A Phase 1 study testing ADX-001 in people with Healthy, run by Adaxion Therapeutics at 1 site in Australia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is 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 Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
ADX-001
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
88 participants
Where
1 siteAustralia
Study dates
20 Oct 2026to 14 Dec 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • You cannot participate in this study if any of the following apply to you:
  • 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.
  • Infections
  • You test positive for HIV, hepatitis B, or hepatitis C.
Show all 34Show fewer
  • 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 TNFα 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Andrew Miller contact

+1-858-361-4192

amiller@adaxiontx.com

Australia1 site, 1 recruiting

  • CMAX Clinical Research

    Adelaide, South Australia, 5000

    Recruiting

Other trials in Australia

About this study

Official 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

This is 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

Read the detailed description

ADX-001 is a new investigational medicine being developed to treat inflammatory diseases, such as inflammatory bowel disease (IBD), including ulcerative colitis and Crohn's disease, and certain rheumatic diseases, such as psoriatic arthritis.

The purpose of this study is to evaluate the safety and tolerability of ADX-001 in healthy adult volunteers. The study will also examine how the body processes the medicine, how the medicine affects the immune system, and whether the body develops antibodies against the medicine. The results of this study will help determine appropriate doses and dosing schedules for future studies in patients with inflammatory diseases.

Conditions
Healthy
Being tested
ADX-001, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ADX-001Drug

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

  • ADX-001Drug

    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).

  • PlaceboDrug

    Matching placebo administered by SC injection or IV infusion according to the route and dosing schedule of the assigned cohort.

Study groups in NCT07876076
Study groupRoleWhat they receive
SAD Cohort 1-5ExperimentalNot described
Receives: Drug: ADX-001; Drug: Placebo
MAD Cohort 6-9ExperimentalNot described
Receives: Drug: ADX-001; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and severity of Treatment Emergent Adverse Events (TEAEs) of single and multiple doses of ADX-001 administered by subcutaneous and intravenous injection

    Measured: From first dose through Day 365 for participants receiving a single dose and through Day 505 for participants receiving multiple doses.

Secondary outcomes (20)

  1. PK Parameters peak concentration (Cmax) - SAD

    Measured: Pre-dose on Day 1 through Day 365

  2. PK Parameters peak concentration (Cmax) - MAD

    Measured: Pre-dose on Day 1 through Day 87

  3. Area under the concentration-time curve (AUC0-t) - SAD

    Measured: Pre-dose on Day 1 through Day 365

  4. Area under the concentration-time curve (AUC0-t) - MAD

    Measured: Pre-dose on Day 1 through Day 87

  5. Terminal elimination half-life (t1/2) - SAD

    Measured: Pre-dose on Day 1 through Day 365

  6. Terminal elimination half-life (t1/2) - MAD

    Measured: Pre-dose on Day 1 through Day 87

  7. Clearance (CL) - SAD

    Measured: Pre-dose on Day 1 through Day 365

  8. Clearance (CL) - MAD

    Measured: Pre-dose on Day 1 through Day 87

  9. Volume of distribution (Vz) - SAD

    Measured: Pre-dose on Day 1 through Day 365

  10. Volume of distribution (Vz) - MAD

    Measured: Pre-dose on Day 1 through Day 87

  11. Serum concentrations of free CD22L- SAD

    Measured: Pre-dose on Day 1 through Day 365

  12. Serum concentrations of free CD22L- MAD

    Measured: Pre-dose on Day 1 through Day 87

  13. Incidence of treatment-emergent anti-drug antibodies (ADA)

    Measured: From Day 14 through Day 112 after a single dose, and through 56 days after the final dose following multiple doses

  14. Maximum observed serum concentration (Cmax) of ADX-001 by ADA status

    Measured: From Day 14 through Day 112 after a single dose, and through 56 days after the final dose following multiple doses

  15. Minimum observed serum concentration (Cmin) of ADX-001 by ADA status

    Measured: From Day 14 through Day 112 after a single dose, and through 56 days after the final dose following multiple doses

  16. Area under the serum concentration-time curve (AUC0-last) of ADX-001 by ADA status

    Measured: From Day 14 through Day 112 after a single dose, and through 56 days after the final dose following multiple doses

  17. Area under the serum concentration-time curve over the dosing interval (AUCτ) of ADX-001 by ADA status

    Measured: From Day 14 through Day 112 after a single dose, and through 56 days after the final dose following multiple doses

  18. Clearance (CL) of ADX-001 by ADA status

    Measured: From Day 14 through Day 112 after a single dose, and through 56 days after the final dose following multiple doses

  19. Terminal elimination half-life (t½) of ADX-001 by ADA status

    Measured: From Day 14 through Day 112 after a single dose, and through 56 days after the final dose following multiple doses

  20. Incidence of treatment-emergent adverse events by ADA status

    Measured: From Day 14 through Day 112 after a single dose, and through 56 days after the final dose following multiple doses

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2026
  2. Study start20 Oct 2026
  3. Primary completion29 Jul 2027 (estimated)
  4. Study completion14 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07876076
Sponsor's protocol ID
ADX-001-CLN-01
Status last verified
Oct 2026
First submitted
2 Oct 2026
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ADX-001 in people with Healthy, run by Adaxion Therapeutics at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Andrew Miller (+1-858-361-4192, amiller@adaxiontx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of Treatment Emergent Adverse Events (TEAEs) of single and multiple doses of ADX-001 administered by subcutaneous and intravenous injection (time frame: From first dose through Day 365 for participants receiving a single dose and through Day 505 for participants receiving multiple doses.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07876076.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.

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Clinical Trial NCT07876076 | AzTrials