A Phase 1, Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ISM8969
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorInSilico Medicine Hong Kong Limited
About this trial
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.
Eligibility criteria
Qualifiers
Male or female participants, including adult participants (≥18 and <65 years of age) for the SAD cohorts 1-6 and MAD cohorts 1-3, and elderly participants (≥65 and ≤80 years of age) for MAD cohort 4.
Body mass index (BMI) >18.5 and <30.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females.
Non-smokers (no use of tobacco or nicotine products within 1 month prior to screening).
Healthy as defined the current protocol.
Disqualifiers
Columbia suicide severity rating scale (C-SSRS) score above Type 1 ideation.
Positive serology test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antigen and antibody, treponema pallidum antibody or QuantiFERON®-TB test at screening.
Positive pregnancy test or lactating female participant.
History of any central nervous system (CNS) disorder or history of seizure of any cause.
Trial design
Treatments tested in this trial
- ISM8969 tablets or placebo
- ISM8969 tablets or placebo
- ISM8969 tablets or placebo
Treatment groups
100 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov