drugset
drugset / Trial / NCT06565208

First in Human SAD/MAD Safety and PK Study With Adult DMD Safety and PK Cohort

NCT06565208 ↗

Phase 0 Completed 77 enrolled Satellos Bioscience, Inc.
RandomizedSequentialOpen-labelTreatment

Summary

This is a first-in-human (FIH), Phase 1 study of orally administered SAT-3247 in healthy adult volunteers (HVs) and adult participants with DMD to determine safety, tolerability, pharmacokinetics and pharmacodynamics.

Timeline

Start
2024-08-21
Primary completion
2025-04-28
Completion
2025-04-28

Drugs

EvaluationDrugModalityDoseRoute
Subject SAT-3247 Small molecule 10 mg Oral
Subject SAT-3247 Small molecule 50 mg Oral
Subject SAT-3247 Small molecule 60 mg Oral
Subject SAT-3247 Small molecule 120 mg Oral
Subject SAT-3247 Small molecule 150 mg Oral
Subject SAT-3247 Small molecule 180 mg Oral
Subject SAT-3247 Small molecule 240 mg Oral
Subject SAT-3247 Small molecule 300 mg Oral
Subject SAT-3247 Small molecule 400 mg Oral

Indications

Duchenne muscular dystrophy