A Phase 1/Phase 2 Open-label Study to Evaluate the Safety, Tolerability, and Efficacy of a Single Intravenous Administration of SAR444836 in Adult Participants With Phenylketonuria
Public ClinicalTrials.gov record NCT05972629. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Study identification
- NCT ID
- NCT05972629
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Lead sponsor
- Sanofi
- Industry
- Enrollment
- 32 participants
Conditions and interventions
Conditions
Interventions
- SAR444836 Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 6, 2023
- Primary completion
- Apr 1, 2030
- Completion
- Apr 1, 2030
- Last update posted
- Sep 22, 2025
2023 – 2030
United States locations
- U.S. sites
- 7
- U.S. states
- 7
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California San Francisco- Site Number : 8400007 | San Francisco | California | 94143 | — |
| Children's Hospital IMD Clinic- Site Number : 8400015 | Aurora | Colorado | 80045 | — |
| University of Florida-Genetics- Site Number : 8400010 | Gainesville | Florida | 32610 | — |
| UHCMC- Site Number : 8400014 | Cleveland | Ohio | 44106 | — |
| UPMC Children's Hospital of Pittsburgh-4401 Penn Ave- Site Number : 8400018 | Pittsburgh | Pennsylvania | 15224-1334 | — |
| Medical University of SC- Site Number : 8400004 | Charleston | South Carolina | 29425 | — |
| University of Texas- Site Number : 8400002 | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05972629, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 22, 2025 · Synced Jun 26, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05972629 live on ClinicalTrials.gov.