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A Trial to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of SFL-0821 in Adults With FSHD
Sponsor: Soufflé Therapeutics, Inc.
Summary
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)
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2026-09
Completion Date
2028-04
Last Updated
2026-09-03
Healthy Volunteers
No
Interventions
SFL-0821 for injection
single or multiple doses of SFL-0821 by intravenous (IV) infusion
Placebo
calculated volume to match active treatment by IV infusion
Locations (6)
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
Wesley Research Institute
Brisbane, Queensland, Australia
Mater Hospital Brisbane
South Brisbane, Queensland, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Pacific Clinic Research Network
Auckland, Auckland, New Zealand