A Phase 1 interventional study of ADX-001 and ADX-001 in Healthy, sponsored by Adaxion Therapeutics. Recruiting at 1 site in Australia. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Adaxion Therapeutics · Phase 1, Interventional, and Treatment
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
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.
This is the only study on the registry with Adaxion Therapeutics as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
You cannot participate in this study if any of the following apply to you:
Medical Conditions
Infections
4. Heart and Blood Pressure Problems 5. Previous Medications or Treatments
You donated blood, plasma, or too recently before joining the study.
6. Alcohol or Drug Use. 7. Pregnancy and Reproductive Considerations
You are unwilling to use the required methods.
8. Participation in Other Research Studies
You have previously participated in this study.
9. Ability to Participate
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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: ADX-001 · Drug: Placebo
Drug: ADX-001 · Drug: Placebo
ADX-001 administered as a single dose according to the assigned cohort and route of administration (SC or IV).
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).
Matching placebo administered by SC injection or IV infusion according to the route and dosing schedule of the assigned cohort.
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.
PK Parameters peak concentration (Cmax) - SAD
Time frame: Pre-dose on Day 1 through Day 365
PK Parameters peak concentration (Cmax) - MAD
Time frame: Pre-dose on Day 1 through Day 87
Area under the concentration-time curve (AUC0-t) - SAD
Time frame: Pre-dose on Day 1 through Day 365
Area under the concentration-time curve (AUC0-t) - MAD
Time frame: Pre-dose on Day 1 through Day 87
Terminal elimination half-life (t1/2) - SAD
Time frame: Pre-dose on Day 1 through Day 365
Terminal elimination half-life (t1/2) - MAD
Time frame: Pre-dose on Day 1 through Day 87
Clearance (CL) - SAD
Time frame: Pre-dose on Day 1 through Day 365
Clearance (CL) - MAD
Time frame: Pre-dose on Day 1 through Day 87
Volume of distribution (Vz) - SAD
Time frame: Pre-dose on Day 1 through Day 365
Volume of distribution (Vz) - MAD
Time frame: Pre-dose on Day 1 through Day 87
Serum concentrations of free CD22L- SAD
Time frame: Pre-dose on Day 1 through Day 365
Serum concentrations of free CD22L- MAD
Time frame: Pre-dose on Day 1 through Day 87
Incidence of treatment-emergent anti-drug antibodies (ADA)
Time frame: From Day 14 through Day 112 after a single dose, and through 56 days after the final dose following multiple doses
Maximum observed serum concentration (Cmax) of ADX-001 by ADA status
Time frame: From Day 14 through Day 112 after a single dose, and through 56 days after the final dose following multiple doses
Minimum observed serum concentration (Cmin) of ADX-001 by ADA status
Time frame: From Day 14 through Day 112 after a single dose, and through 56 days after the final dose following multiple doses
Area under the serum concentration-time curve (AUC0-last) of ADX-001 by ADA status
Time frame: From Day 14 through Day 112 after a single dose, and through 56 days after the final dose following multiple doses
Area under the serum concentration-time curve over the dosing interval (AUCτ) of ADX-001 by ADA status
Time frame: From Day 14 through Day 112 after a single dose, and through 56 days after the final dose following multiple doses
Clearance (CL) of ADX-001 by ADA status
Time frame: From Day 14 through Day 112 after a single dose, and through 56 days after the final dose following multiple doses
Terminal elimination half-life (t½) of ADX-001 by ADA status
Time frame: From Day 14 through Day 112 after a single dose, and through 56 days after the final dose following multiple doses
Incidence of treatment-emergent adverse events by ADA status
Time frame: From Day 14 through Day 112 after a single dose, and through 56 days after the final dose following multiple doses
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.