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A Study to Evaluate the Tolerability, Safety and Efficacy of VGM-R02b

StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Primary and study completion dates: Aug 2026 to Aug 2027v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 2024 to Apr 29, 2024
    • Study site revised
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Phase I, open-label, single-arm, single-dose, trial of VGM-R02b (gene replacement therapy) in patients with Glutaric Acidemia Type I (GA-I) who meet enrollment criteria and are genetically confirmed by GCDH gene mutation. 1 to 3 patients aged≤ 6 years at the time of screening will be enrolled in each dose group in the dose escalation part. In the dose expansion part, the sample size will be statistically calculated and adjusted according to the efficacy and safety data in the dose escalation part.
Trial Details
NCT Number NCT06217861
Lead Sponsor Shanghai Vitalgen BioPharma Co., Ltd.
Conditions
(from sponsor)		 Glutaric Acidemia Type I, Glutaric Aciduria Type I
Related terms Glutaric Acidemia I
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov