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A Phase 1/Phase 2, Open-label, Dose-escalation, and Dose Expansion Study to Evaluate the Safety, Tolerability, and Efficacy of SAR444836, an Adeno-associated Viral Vector-mediated Gene Transfer of Human Phenylalanine Hydroxylase, in Adult Participants With Phenylketonuria

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Trial Profile

A Phase 1/Phase 2, Open-label, Dose-escalation, and Dose Expansion Study to Evaluate the Safety, Tolerability, and Efficacy of SAR444836, an Adeno-associated Viral Vector-mediated Gene Transfer of Human Phenylalanine Hydroxylase, in Adult Participants With Phenylketonuria

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 08 May 2025

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At a glance

  • Drugs SAR 444836 (Primary)
  • Indications Phenylketonuria
  • Focus Adverse reactions
  • Sponsors Sanofi

Most Recent Events

  • 29 Apr 2025 Protocol has been amended(Time frame for primary endpoind has been changed from From Baseline to Week 96 to From Baseline to Week 260, Secondary outcome measures also amended).
  • 29 Apr 2025 Time frame for primary endpoind has been changed from From Baseline to Week 96 to From Baseline to Week 260. Secondary outcome measures also amended.
  • 29 Apr 2025 Planned End Date changed from 31 Jul 2027 to 1 Apr 2031.

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