A Clinical Trial to Study Single- and Multiple- Doses of GSM-779690T in Healthy Participants (NCT07155980) | Clinical Trial Compass
WithdrawnPhase 1
A Clinical Trial to Study Single- and Multiple- Doses of GSM-779690T in Healthy Participants
Stopped: The protocol is being withdrawn prior to enrollment due to a redesign of the study approach under the existing IND.
United States0Started 2025-11-09
Plain-language 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.
Who can participate
Age range20 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Healthy, cognitively typical, and aged 20-45 years (inclusive).
✓. Current Mini Mental State Examination (MMSE) score between 27 and 30 (inclusive) at screening.
✓. Able to provide their own written informed consent.
✓. 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:
✓. 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 4 weeks prior to screening.
Exclusion criteria
✕
What they're measuring
1
Number and percentage of participants reporting treatment-emergent adverse events and serious adverse events after single and multiple oral doses of GSM-779690-T
Timeframe: 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.
. Renal function with an estimated glomerular filtration rate (eGFR) less than 90 mL/minute/1.73 m2 Note: less than 80 mL/minute/1.73 m2 in older participants enrolling in Cohort 10.
✕. Presence of crystalluria in urinalysis at screening.
✕0. A clinically significantly abnormal 12-lead ECG result, including but not limited to: heart rate \< 50 or \> 100 beats per minute (bpm), QRS \> 160 ms, QTcF \> 450 ms in men \& 460 ms in women, or any clinically significant arrhythmia including Mobitz type II second-degree atrioventricular (AV)(Hay block) block and bifascicular block.
✕1. A seated systolic blood pressure of \< 100 or \> 140 millimeters of mercury (mm Hg) or diastolic blood pressure of \< 60 or \> 90 mm Hg.
✕. Two readings should be taken approximately 1 minute apart and the average of the two will be applied.
✕. If the average is outside of the approved range, the procedure will be repeated following a brief rest.
✕2. Postural change at 3 min upon standing from seated position of:
✕. \> 20 mm Hg systolic or \> 10 mm Hg diastolic decrease in blood pressure