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NOT YET RECRUITING
NCT07798609
PHASE1/PHASE2

A Trial to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of SFL-0821 in Adults With FSHD

Sponsor: Soufflé Therapeutics, Inc.

View on ClinicalTrials.gov

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

DRUG

SFL-0821 for injection

single or multiple doses of SFL-0821 by intravenous (IV) infusion

DRUG

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