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A Phase 1, First-In-Human, Randomized, Double-Blind, Placebo-Controlled 3-Part Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PROT-001 in Healthy Adult Participants

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Trial Profile

A Phase 1, First-In-Human, Randomized, Double-Blind, Placebo-Controlled 3-Part Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PROT-001 in Healthy Adult Participants

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 10 Jun 2025

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At a glance

  • Drugs PROT 001 (Primary)
  • Indications Amyloid light-chain amyloidosis
  • Focus Adverse reactions; First in man
  • Sponsors Protego Biopharma

Most Recent Events

  • 03 Jun 2025 Planned primary completion date changed from 1 Oct 2025 to 1 Jan 2026.
  • 03 Jun 2025 Planned initiation date changed from 1 Jun 2025 to 29 May 2025.
  • 03 Jun 2025 Status changed from not yet recruiting to recruiting.

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