A Study of S-606001 as Monotherapy in Participants With Late-onset Pompe Disease (LOPD)

Sponsor
Shionogi
Study ID
NCT07787650
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • S-606001 — DRUG
    S-606001 will be administered orally as a tablet.

Study Details

The primary purpose of this study is to evaluate the safety and tolerability profile of S-606001 in participants with LOPD.

Key Dates

First listed
Aug 26, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Oct 31, 2028
Completion
Oct 31, 2028

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: S-606001
    Participants will receive S-606001.

Primary Outcome Measure

Number of Participants with Treatment-emergent Adverse Events [ Time Frame: Baseline (Day 1) through Week 49 ]

Central Contacts

  • Shionogi Clinical Trials Administrator Clinical Support Help Line
    1-800-849-9707
    [email protected]

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