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

Not Applicable

Not yet recruiting

• Conditions: Healthy Adult Participants
• Interventions: Drug: GSM-779690T; Other: Placebo

• Registration Number: NCT07155980
• Lead Sponsor: Acta Pharmaceuticals, Inc

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-13
• Study First Submitted QC: 2025-08-26
• Last Update Submitted: 2025-08-26
• Study First Posted: 2025-09-04
• Last Update Posted: 2025-09-04
• Study Start: 2025-10-09
• Primary Completion: 2026-06-11
• Study Completion: 2026-06-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 01: 20 mg	GSM-779690T	Healthy adult participants receiving a single dose in the SAD study.
Cohort 01: 20 mg	Placebo	Healthy adult participants receiving a single dose in the SAD study.
Cohort 02: dose to be determined	GSM-779690T	Healthy adult participants receiving a single dose in the SAD study.
Cohort 02: dose to be determined	Placebo	Healthy adult participants receiving a single dose in the SAD study.
Cohort 03: dose to be determined	GSM-779690T	Healthy adult participants receiving a single dose in the SAD study.
Cohort 03: dose to be determined	Placebo	Healthy adult participants receiving a single dose in the SAD study.
Cohort 04: dose to be determined	GSM-779690T	Healthy adult participants receiving a single dose (x2) in the SAD study.
Cohort 04: dose to be determined	Placebo	Healthy adult participants receiving a single dose (x2) in the SAD study.
Cohort 05: dose to be determined	GSM-779690T	Healthy adult participants receiving a single dose (x2) in the SAD study.
Cohort 05: dose to be determined	Placebo	Healthy adult participants receiving a single dose (x2) in the SAD study.
Cohort 06: dose to be determined	GSM-779690T	Healthy adult participants receiving a single dose in the SAD study.
Cohort 06: dose to be determined	Placebo	Healthy adult participants receiving a single dose in the SAD study.
Cohort 07: dose TBD	GSM-779690T	Healthy adult participants receiving a multiple dose in the MAD study.
Cohort 07: dose TBD	Placebo	Healthy adult participants receiving a multiple dose in the MAD study.
Cohort 08: dose TBD	GSM-779690T	Healthy adult participants receiving a multiple dose in the MAD study.
Cohort 08: dose TBD	Placebo	Healthy adult participants receiving a multiple dose in the MAD study.
Cohort 09: dose TBD	GSM-779690T	Healthy adult participants receiving a multiple dose in the MAD study.
Cohort 09: dose TBD	Placebo	Healthy adult participants receiving a multiple dose in the MAD study.
Cohort 10: dose TBD	GSM-779690T	Healthy older-adult participants receiving a multiple dose in the MAD study.
Cohort 10: dose TBD	Placebo	Healthy older-adult participants receiving a multiple dose in the MAD study.

Primary Outcome Measures

Name	Time	Method
Number and percentage of participants reporting treatment-emergent adverse events and serious adverse events after single and multiple oral doses of GSM-779690-T	From enrollment through study completion, approximately 7 days in groups 1, 2, 3, and 6; 14 days in groups 4 and 5; and 21 days in groups 7, 8, 9, and 10.	Treatment emergent adverse events and serious adverse events will be summarized for each treatment group. The frequencies of treatment emergent adverse events and serious adverse events between the participants in each group will be compared.

Trial Locations

Locations (1)

Worldwide Clinical Trials; 🇺🇸 San Antonio, Texas, United States