Phase 1/2Recruiting
A Trial to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of SFL-0821 in Adults With FSHD
A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Trial to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of SFL-0821 in Adults With Facioscapulohumeral Muscular Dystrophy (FSHD)
- Sponsor
- Soufflé Therapeutics, Inc. (Industry)
- Enrolment
- 90 planned
- Conditions
- Facioscapulohumeral Muscular Dystrophy (FSHD)
- Interventions
- SFL-0821 for injection; Placebo
- Ages
- adults, older adults
- Registry
- NCT07798609
Full record on ClinicalTrials.gov
From the registry
The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of SFL-0821 in adult patients with Facioscapulohumeral Muscular Dystrophy (FSHD)
Primary outcomes
- Number of participants with treatment-emergent adverse events, serious adverse events, and any other dose-limiting toxicities as assessed by CTCAE v6.0.
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered