NCT07876076 A Study of Single and Multiple Subcutaneous or Intravenous Doses of ADX-001 in Healthy Adults to Assess Safety, Effects, and Immune Response
| NCT ID | NCT07876076 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Adaxion Therapeutics |
| Condition | Healthy |
| Study Type | INTERVENTIONAL |
| Enrollment | 88 participants |
| Start Date | 2026-10-20 |
| Primary Completion | 2027-07-29 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 88 participants in total. It began in 2026-10-20 with a primary completion date of 2027-07-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07876076 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Healthy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07876076 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07876076 currently recruiting?
Yes, NCT07876076 is actively recruiting participants. Contact the research team at amiller@adaxiontx.com for enrollment information.
Where is the NCT07876076 trial being conducted?
This trial is being conducted at Adelaide, Australia.
Who is sponsoring the NCT07876076 clinical trial?
NCT07876076 is sponsored by Adaxion Therapeutics. The trial plans to enroll 88 participants.