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Phase 1Recruiting

A Phase 1, Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ISM8969

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Oral Doses of ISM8969 in Healthy Adult and Elderly Participants and Obese Adult Participants at Risk of Cardiovascular Disease

Sponsor
InSilico Medicine Hong Kong Limited (Industry)
Enrolment
100 planned
Conditions
Healthy Subjects (HS); Obese Adult Participants at Risk of Cardiovascular Disease
Interventions
ISM8969 tablets or placebo; ISM8969 tablets or placebo; ISM8969 tablets or placebo
Ages
adults, older adults
Registry
NCT07581431

Full record on ClinicalTrials.gov

From the registry

This is a single center, phase 1, randomized, double-blind, placebo-controlled sequential study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending oral doses of ISM8969 in healthy adults and elderly participants and obese adult participants at risk of cardiovascular disease.

Primary outcomes

  • The incidence of Adverse Events (AEs) after single or multiple doses of ISM8969 tablets.
  • Number of Participants with Clinical Laboratory Abnormalities, and Abnormalities in Vital Signs, Physical Examinations,12-lead ECG
  • C-SSRS Score(Type 1 to Type 5)

History

  1. Study completion expected

  2. Primary completion expected

  3. Last registry update

  4. Started

  5. Registered