drugset / Trial / NCT05650112
Safety and Tolerability of FB-001 in Healthy Adult Volunteers and Adult Subjects With Enteric Hyperoxaluria
RandomizedParallel-groupTriple-blindTreatment
Summary
This Phase 1, first-in-human, randomized, double-blinded, placebo controlled study is evaluating FB-001 in healthy volunteers (Part 1) and participants diagnosed with enteric hyperoxaluria (Part 2). Eligible participants receive investigational product and undergo safety monitoring, evaluations and subsequent follow-up after investigational product administration.
Timeline
- Start
- 2022-11-16
- Primary completion
- 2024-08-31
- Completion
- 2024-08-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | FB-001 | Unknown | 1e+11 cells | Oral |
Indications
No indication recorded.