Phase 2 Study of SAT-3247 in Pediatric Ambulatory Patients

Part of paid clinical trials in Los Angeles, California.

Sponsor
Satellos Bioscience, Inc.
Study ID
NCT07287189
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
7 Years - 9 Years
Healthy Volunteers
Not accepted

Interventions

  • SAT-3247 — DRUG
    SAT-3247 is a selective AAK1 inhibitor for oral tablet administration which promotes functional rescue of asymmetric satellite cell division, resulting in the robust production of muscle progenitor cells, subsequent improvement in muscle regeneration, and enhanced muscle function.
  • Placebo — DRUG
    matching placebo oral tablets

Study Details

Phase 2a trial of SAT-3247 in ambulatory DMD patients aged ≥ 7 and \< 10 years. The trial will study two doses of SAT-3247 in a randomized, double-blind, placebo-controlled weekday regimen for 12 weeks to determine the optimal dose, safety, tolerability, and preliminary efficacy.

Key Dates

Start date
Dec 8, 2025
Status verified
May 2026
Primary completion
Mar 31, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
51 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: SAT-3247 60 mg
    SAT-3247 60 mg oral tablets administered daily for 12 weeks
  • Active Comparator: SAT-3247 120 mg
    SAT-3247 120 mg oral tablets administered daily for 12 weeks; note the 120 mg dose will not be studied in the US and Canada
  • Placebo Comparator: placebo
    placebo oral tablets administered daily for 12 weeks

Primary Outcome Measure

Safety of SAT-3247 [ Time Frame: 12 weeks ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
University of California Los AngelesLos AngelesCalifornia90095
Denisse Velazquez
[email protected]
310-825-3264
Colorado Children'sAuroraColorado80045
Nana Welnick
[email protected]
720-777-8608
Lurie Children'sChicagoIllinois60611
Alka Maheshwari
[email protected]
312-227-3813
UMass Memorial Medical CenterWorcesterMassachusetts01655
Sarah Figueira
[email protected]
508-856-1604
Washington UniversitySt LouisMissouri63110
Natalie Goedeker
[email protected]
314-362-4919
Nationwide Children's HospitalColumbusOhio43205
Jeremy Thompson
[email protected]
614-355-2923
Seattle Children'sSeattleWashington98105
Marissa Robertson
[email protected]
206-987-5457

Find similar trials in Los Angeles, CA

By condition
Duchenne muscular dystrophy
By specialty
Pediatrics
By research site
University of California Los Angeles· Los Angeles, CAColorado Children's· Aurora, COLurie Children's· Chicago, ILUMass Memorial Medical Center· Worcester, MAWashington University· St Louis, MONationwide Children's Hospital· Columbus, OH

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