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

NCT07876076 | Recruiting Phase 1

• 1 other identifier: ADX-001-CLN-01
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (20)

• PK Parameters peak concentration (Cmax) - SAD

  Pre-dose on Day 1 through Day 365

• PK Parameters peak concentration (Cmax) - MAD

  Pre-dose on Day 1 through Day 87

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

  Pre-dose on Day 1 through Day 365

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

  Pre-dose on Day 1 through Day 87

• Terminal elimination half-life (t1/2) - SAD

  Pre-dose on Day 1 through Day 365

Study Arms (2)

SAD Cohort 1-5

EXPERIMENTAL

Drug: ADX-001; Drug: Placebo

MAD Cohort 6-9

EXPERIMENTAL

Drug: ADX-001; Drug: Placebo

Interventions

ADX-001 DRUG

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

SAD Cohort 1-5

Placebo DRUG

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

MAD Cohort 6-9; SAD Cohort 1-5

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• \. Heart and Blood Pressure Problems 5. Previous Medications or Treatments

Sponsors & Collaborators

• Adaxion Therapeutics: lead

Study Sites (1)

CMAX Clinical Research

Adelaide, South Australia, 5000, Australia

RECRUITING

Central Study Contacts

Andrew Miller

CONTACT

+1-858-361-4192; amiller@adaxiontx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2026
• First Posted: October 15, 2026
• Study Start: October 20, 2026
• Primary Completion (Estimated): July 29, 2027
• Study Completion (Estimated): December 14, 2028
• Last Updated: October 21, 2026

Record last verified: 2026-10

Locations

AU (1)