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

November 2, 2026 updated by: Adaxion Therapeutics

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
88

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • CMAX Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SAD Cohort 1-5
Drug: ADX-001

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

Drug: 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).

Drug: Placebo

Matching placebo administered by SC injection or IV infusion according to the route and dosing schedule of the assigned cohort.
Experimental: MAD Cohort 6-9
Drug: ADX-001

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

Drug: 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).

Drug: Placebo

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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.
From first dose through Day 365 for participants receiving a single dose and through Day 505 for participants receiving multiple doses.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
PK Parameters peak concentration (Cmax) - SAD
Time Frame: Pre-dose on Day 1 through Day 365
Pre-dose on Day 1 through Day 365
PK Parameters peak concentration (Cmax) - MAD
Time Frame: Pre-dose on Day 1 through Day 87
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
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
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
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
Pre-dose on Day 1 through Day 87
Clearance (CL) - SAD
Time Frame: Pre-dose on Day 1 through Day 365
Pre-dose on Day 1 through Day 365
Clearance (CL) - MAD
Time Frame: Pre-dose on Day 1 through Day 87
Pre-dose on Day 1 through Day 87
Volume of distribution (Vz) - SAD
Time Frame: Pre-dose on Day 1 through Day 365
Pre-dose on Day 1 through Day 365
Volume of distribution (Vz) - MAD
Time Frame: Pre-dose on Day 1 through Day 87
Pre-dose on Day 1 through Day 87
Serum concentrations of free CD22L- SAD
Time Frame: Pre-dose on Day 1 through Day 365
Pre-dose on Day 1 through Day 365
Serum concentrations of free CD22L- MAD
Time Frame: Pre-dose on Day 1 through Day 87
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
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
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
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
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
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
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
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 Day 14 through Day 112 after a single dose, and through 56 days after the final dose following multiple doses

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Adaxion Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 29, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 14, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ADX-001-CLN-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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