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A PHASE 1 TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, PK, AND PD of AX-0810 IN HEALTHY PARTICIPANTS

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Trial Profile

A PHASE 1 TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, PK, AND PD of AX-0810 IN HEALTHY PARTICIPANTS

Status: Not yet recruiting
Phase of Trial: Phase I

Latest Information Update: 10 Nov 2025

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At a glance

  • Drugs AX 0810 (Primary)
  • Indications Liver disorders
  • Focus Adverse reactions; First in man; Pharmacokinetics
  • Acronyms PQ-0810-001
  • Sponsors ProQR Therapeutics

Most Recent Events

  • 06 Nov 2025 According to a ProQR Therapeutics media release, In November, the Company hosted a virtual analyst and investor event focused on AX-0810(external link), highlighting the Phase 1 trial design and target engagement/biomarker strategy.
  • 06 Nov 2025 According to a ProQR Therapeutics media release, the company Initiating Phase 1 study of AX-0810 in healthy volunteers, with initial safety, tolerability, and PK data from Cohort 1 expected by year-end, and target engagement data from all cohorts in H1 2026.
  • 20 Oct 2025 According to a ProQR Therapeutics media release, the company announced that the Central Committee on Research Involving Human Subjects (CCMO) has authorized ProQR Clinical Trial Application (CTA) for a Phase 1 study of AX-0810 in healthy volunteers.

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