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NOT YET RECRUITING
NCT07876076
PHASE1

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

Sponsor: Adaxion Therapeutics

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

88

Start Date

2026-10-06

Completion Date

2028-12-14

Last Updated

2026-10-15

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

ADX-001

ADX-001 administered as a single dose according to assigned cohort: 150 mg SC, 300 mg SC, 600 mg SC, 600 mg IV, or 900 mg IV.

DRUG

ADX-001

ADX-001 administered every 4 weeks (Q4W) for 4 doses according to assigned cohort: 150 mg SC for 4 doses; 300 mg SC for 4 doses; 600 mg IV for the first 2 doses followed by 300 mg SC for the final 2 doses; or 900 mg IV for the first 2 doses followed by 300 mg SC for the final 2 doses.

DRUG

Placebo

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