Phase 1 Study Evaluating Safety and Effects of Oral ISM8969 in Healthy Adults, Elderly, and Obese Adults at Cardiovascular Risk

What this Trial Is About

Researchers are conducting a phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ISM8969 in healthy adults, elderly participants, and obese adults at risk of cardiovascular disease. The study aims to understand how the drug is processed and tolerated in these populations. Participants will receive ISM8969 tablets or placebo orally in different groups. Healthy adults will be assigned to single ascending dose SAD cohorts with up to 6 dose levels or multiple ascending dose MAD cohorts for up to 14 days. Elderly participants and obese adults at cardiovascular risk will also receive ISM8969 or placebo up to 14 days. The study is conducted sequentially to evaluate single and multiple doses. During the study, participants will be monitored for adverse events, laboratory abnormalities, vital signs, physical exams, and ECG changes up to 14 days after the last dose. Pharmacokinetic measures such as drug concentration and clearance will be assessed at various time points. Safety assessments include suicide severity rating scores and changes in blood markers like high sensitivity C-reactive protein. The total participation time includes dosing and follow-up periods lasting up to several weeks.

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