Nucleus Network Pty Ltd
Melbourne, Victoria, 3004, Australia
NCT Number: NCT07690228
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.
Trial opening soon.
Get Notified18 year–55 year
All sexes
Interventional
Phase 1
Melbourne, Victoria, 3004, Australia
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:
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:
Opaque capsules for oral consumption
Opaque capsules for oral consumption
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Acta Pharmaceuticals
Industry
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
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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