Healthy Adult ParticipantsPhase 1NCT07690228
A Study of GSM-779690T in Healthy Adult Participants
A Phase 1 study testing GSM-779690T in people with Healthy Adult Participants and Alzheimer Disease, run by Acta Pharmaceuticals at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants, Alzheimer Disease
- What is being tested?
- GSM-779690T
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteAustralia
- Study dates
- 15 Aug 2026to 15 Jul 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
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:
- 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).
- Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or who are postmenopausal.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site
Nucleus Network Pty Ltd
Melbourne, Victoria, 3004
Nucleus Network Melbourne, 1800 243 733, melbourne@nucleusnetwork.com
Ofer Gonen
About this study
Official 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
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
- Being tested
- GSM-779690T, Placebo
- Keywords
- Pharmacokinetics, pharmacodynamics, single ascending dose
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSM-779690TDrug
Opaque capsules for oral consumption
PlaceboDrug
Opaque capsules for oral consumption
| Study group | Role | What they receive |
|---|---|---|
| Active Drug GSM-779690T | Active comparator | Not described Receives: Drug: GSM-779690T |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Evaluate the pharmacokinetics (Area under the plasma concentration curve) of GSM-779690T after a single dose via measuring concentration levels in the blood.
Measured: 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.
Evaluate the pharmacokinetics (Area Under the Plasma Concentration Curve) of GSM-779690T after multiple doses via measuring concentration levels in the blood.
Measured: At Pre-Dose, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 14, Day 15, Day 16 Post-Dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start15 Aug 2026 (estimated)
- Primary completion15 Aug 2026 (estimated)
- Study completion15 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acta Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07690228
- Sponsor's protocol ID
- ACT-C506
- Other IDs
- ACT-C506
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07690228
- Acronym / sponsor ID
- ACT-C506
- Conditions
- Healthy Adult Participants, Alzheimer Disease
- Keywords
- Pharmacokinetics, pharmacodynamics, single ascending dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Acta PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 15 Jul 2027 (estimated)
- First posted
- 8 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Drug GSM-779690T | Active comparator | Drug: GSM-779690T |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSM-779690TOpaque capsules for oral consumption | Drug | Active Drug GSM-779690T |
| PlaceboOpaque capsules for oral consumption | Drug | Placebo |
Primary outcome
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.
2 secondary outcomes
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSM-779690T in people with Healthy Adult Participants and Alzheimer Disease, run by Acta Pharmaceuticals at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angela L Britton, MS (13017580468, abritton@actapharmaceuticals.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.