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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

Trial Profile

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

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 19 Nov 2024

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At a glance

  • Drugs ADX 038
  • Indications Paroxysmal nocturnal haemoglobinuria
  • Focus Adverse reactions; First in man
  • Sponsors ADARx Pharmaceuticals
  • Most Recent Events

    • 15 Nov 2024 Planned number of patients changed from 53 to 50, Phase has been changed to Phase 1/2 and sequential has been added to design terms.
    • 15 Nov 2024 Planned End Date changed from 30 Jun 2025 to 30 Sep 2026.
    • 15 Nov 2024 Planned primary completion date changed from 30 Nov 2024 to 30 Mar 2026.

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