A Study of GSM-779690T in Healthy Adult Participants

Sponsor
Acta Pharmaceuticals
Study ID
NCT07690228
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • GSM-779690T — DRUG
    Opaque capsules for oral consumption
  • Placebo — DRUG
    Opaque capsules for oral consumption

Study Details

A Phase 1, single-centre, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of a single and multiple dose regimens of GSM-779690T in healthy adults. This first-in-human study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GSM-779690T.

Key Dates

First listed
Jul 8, 2026
Start date
Aug 15, 2026
Status verified
Jul 2026
Primary completion
Aug 15, 2026
Completion
Jul 15, 2027

Study Design

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

Arms

  • Active Comparator: Active Drug GSM-779690T
  • Placebo Comparator: Placebo

Primary Outcome Measure

Safety Evaluation [ Time Frame: From enrollment up to 7 days post dosing in the SAD and up to 21 days post dosing in the MAD. ]

Central Contacts

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