RecruitingPhase 1Phase 2NCT05876312

Safety, Tolerability, PK and PD of ADX-038 in Healthy Participants and Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients

A Phase 1, Randomized, Double Blind, Placebo-Controlled, Single Ascending Dose Study in Healthy Participants Followed by a Phase 2a Open Label Study in Participants With PNH and Residual Anemia to Evaluate the Safety, Tolerability, PK and PD of ADX-038

Sponsor

ADARx Pharmaceuticals, Inc.

Enrollment

50 participants

Start Date

Aug 7, 2023

Study Type

INTERVENTIONAL

Conditions

Paroxysmal Nocturnal Hemoglobinuria, PNH

Summary

The first-in-human Phase 1/Phase 2a study described herein will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of ADX-038 in both healthy participants (HP) and in patients with paroxysmal nocturnal hemoglobinuria (PNH).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called ADX-038 and a drug called Placebo for people with paroxysmal nocturnal hemoglobinuria, pnh. The study is currently recruiting participants at 4 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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