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
This trial accepts healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
ISM8969 tablets or placebo
DrugAdministration: Oral
ISM8969 tablets or placebo
DrugAdministration: Oral
ISM8969 tablets or placebo
DrugAdministration: Oral
Treatment groups
100 Participants
are divided into 3 treatment groupsGroup A: Healthy adults in SAD cohorts will receive ISM8969 or placebo orally up to 6 single-dose levels.Experimental treatment 1 intervention
Group B: Healthy adults and elderly participants in MAD cohorts will receive ISM8969 or placebo up to14 days.Experimental treatment 1 intervention
Group C: Obese adult participants will receive ISM8969 or placebo orally up to 14 days.Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The incidence of Adverse Events (AEs) after single or multiple doses of ISM8969 tablets.
To evaluate the safety and tolerability of ISM8969.
Time frame
Up to 14 days after last dose.2
Number of Participants with Clinical Laboratory Abnormalities, and Abnormalities in Vital Signs, Physical Examinations,12-lead ECG
Vital signs (blood pressure, heart rate, respiratory rate, and oral temperature), physical examinations, 12-lead ECG(heart rate , PR interval, QT interval, RR interval, QTcF and QRS),and clinical laboratory tests (hematology, biochemistry, coagulation and urinalysis, etc.)
Time frame
Up to 14 days after last dose.3
C-SSRS Score(Type 1 to Type 5)
The C-SSRS(Columbia Suicidality Severity Rating Scale) is a suicidal ideation and behavior rating scale to evaluate suicide risk, higher C-SSRS scores mean a worse outcome.
Time frame
Up to 14 days after last dose.Secondary outcomes
1
Maximal observed plasma concentration (Cmax）.
To characterize plasma PK of ISM8969 after the first dose and at steady state.
Time frame
Day 1 and Day 14 after dose.2
Time when the maximal concentration is observed (Tmax).
To characterize plasma PK of ISM8969 after the first dose and at steady state.
Time frame
Day 1 and day 14 after dose.3
Area under the concentration-time curve from time zero to the last observed concentration (AUC0-t).
To characterize plasma PK of ISM8969 after the first dose and at steady state.
Time frame
Day 3 and Day 17 after dose.4
Area under the concentration-time curve from time zero to infinity (extrapolated)(AUC0-inf).
To characterize plasma PK of ISM8969 after single and multiple dose administration.
Time frame
Day 3 and Day 17 after dose.Sponsors and contacts
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Source ClinicalTrials.gov