NCT07155980

A Clinical Trial to Study Single- and Multiple- Doses of GSM-779690T in Healthy Participants

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacology of GSM-779690T in Healthy Adult Participants

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Acta Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, double-blinded, placebo-controlled dose escalating first in human study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) of GSM-779690T. The study will have two parts: a single ascending dose (SAD) component and a multiple ascending dose (MAD) component. The goal of this study is to learn if GSM-779690T is safe and to assess the effects on levels of specific Aβ peptide isoforms in adults. SAD: A total of 48 healthy volunteers are planned to be consented and enrolled to receive a single oral dose of GSM-779690T at increasing strengths or placebo in Cohorts 1 through 6. MAD: A total of 48 healthy volunteers are planned to be consented and enrolled to receive multiple oral doses of GSM-779690T (doses will be informed by SAD data) in Cohorts 7 through 10. Cohort 10 will include healthy older-adults. Participants who have signed an informed consent and meet screening eligibility requirements will be randomly assigned to receive a single oral dose of GSM-779690T or placebo with a 3:1 (active: placebo) ratio at each dose level. The decision to escalate between dose levels in the SAD and to proceed to the MAD will be based on Data Review Committee review of prior cohorts, safety, tolerability, and PK data. The study treatment, GSM-779690T, and all protocol assessments will be administered at the study site by trained study site personnel.

Conditions

• Healthy Adult Participants

Interventions

Type	Name	Description
DRUG	GSM-779690T	Opaque capsules for oral consumption.
OTHER	Placebo	Opaque capsules for oral consumption.

Timeline

• Start date: 2025-11-09
• Primary completion: 2026-07-11
• Completion: 2026-07-11
• First posted: 2025-09-04
• Last updated: 2026-01-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study