A Study of GSM-779690T in Healthy Adult Participants

NCT07690228 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: ACT-C506
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Adult Participants; Alzheimer Disease

Keywords

Pharmacokinetics; pharmacodynamics; single ascending dose

Outcome Measures

Primary Outcomes (1)

• Safety Evaluation

  The number of participants with Adverse Events, with abnormal Vital Signs, abnormal Physical Examination findings, abnormal laboratory Test results, abnormal 12-lead Electrocardiogram (ECG) readings.

  From enrollment up to 7 days post dosing in the SAD and up to 21 days post dosing in the MAD.

Secondary Outcomes (2)

• Area under the plasma concentration curve versus time curve (AUC) after single GSM-779690T dose.

  At pre-dose, post dose on day 1, Day 2, Day 3, and Day 4.

• Area under the plasma concentration versus time curve (AUC) after multiple GSM-779690T doses.

  At Pre-Dose, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 14, Day 15, Day 16 Post-Dose.

Study Arms (2)

Active Drug GSM-779690T

ACTIVE COMPARATOR

Drug: GSM-779690T

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

GSM-779690T DRUG

Opaque capsules for oral consumption

Active Drug GSM-779690T

Placebo DRUG

Opaque capsules for oral consumption

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy and aged 18-55 years.
• Current Mini Mental State Examination (MMSE) score between 27 and 30 at screening.
• Able to provide their own written informed consent.
• Good general health with no disease expected to interfere with the study.
• Able to read, speak, and understand English to ensure compliance with cognitive testing and study visit procedures.
• Must be ambulatory and be willing to remain domiciled in the clinic for the required study procedures.
• Contraception requirements:
• a. Women of childbearing potential (WOCBP) must agree to use a highly effective method of birth control (confirmed by the Investigator) from enrollment, throughout the study duration, and have a negative pregnancy test result at screening. Highly effective methods of birth control (those with a failure rate of \< 1% per year when used consistently and correctly) include: (i) Combined (oestrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal, (ii) Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, or implantable, (iii) Intrauterine device, (iv) Intrauterine hormone-releasing system, (v) Bilateral tubal occlusion, (vi) Tubal ligation, (vii) Sexual abstinence, i.e., refraining from heterosexual intercourse, or (viii) Vasectomized sexual partner (provided that partner is the sole sexual partner of the WOCBP study participant and that the vasectomized partner has received medical assessment of the surgical success).
• b. Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or who are postmenopausal.
• c. Males with childbearing partners must be willing to practice sexual abstinence or use double-barrier protection during study treatment and until 1 week after the last dose of study treatment.
• Participants who meet any of the following criteria must not be included in the study:
• A history of any current or clinically significant gastrointestinal, renal, hepatic, bronchopulmonary, neurological, psychiatric, cardiovascular, endocrinological, ophthalmologic, hematological, or allergic disease or metabolic disorder.
• Use of any concomitant medications is prohibited, other than prescribed birth control methods stable 30 days prior to Day -1.
• A history of chronic use of non-steroidal anti-inflammatory drugs (NSAIDs) or procedures that require intravenous contrast within 72 hours of study initiation.
• A history of a psychiatric disorder such as schizophrenia, bipolar disorder or major depression according to the criteria of the most current version of the Diagnostic and Statistical Manual of Mental Disorders (DSM).

Sponsors & Collaborators

• Acta Pharmaceuticals: lead

Study Sites (1)

Nucleus Network Pty Ltd

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Angela L Britton, MS

CONTACT

13017580468; abritton@actapharmaceuticals.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double (participant, Investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 8, 2026
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): July 15, 2027
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)