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NCT Number: NCT07690228

A Study of GSM-779690T in Healthy Adult Participants

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nucleus Network Pty Ltd

Melbourne, Victoria, 3004, Australia

Location contact

Nucleus Network Melbourne

CONTACT

[email protected]

1800 243 733

Ofer Gonen

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Participants must meet all of the following inclusion criteria to be eligible for enrollment:

  • 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).
  • Any evidence of current suicidal ideation or any previous suicide attempt as evaluated by the Columbia-Suicide Severity Rating Scale (C-SSRS).
  • Diagnosis of a neurodegenerative disease or dementia, including but not limited to Alzheimer's disease (AD), Parkinson's disease, and Huntington's disease.

Treatment and study plan

GSM-779690T

Drug

Opaque capsules for oral consumption

Placebo

Drug

Opaque capsules for oral consumption

Primary outcomes

  1. 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.

    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.

Secondary outcomes

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

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

    Evaluate the pharmacokinetics (Area under the plasma concentration curve) of GSM-779690T after a single dose via measuring concentration levels in the blood.

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

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

    Evaluate the pharmacokinetics (Area Under the Plasma Concentration Curve) of GSM-779690T after multiple doses via measuring concentration levels in the blood.

Study contacts

Contact information is provided by the study sponsor or research team.

Angela L Britton, MS

CONTACT

[email protected]

13017580468

Sponsors and collaborators

Lead sponsor

Acta Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jul 8, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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