To Assess the Effects of Single Dose of JMKX001899 on QTc Interval in Healthy Subjects
- Registration Number
- NCT06473948
- Lead Sponsor
- Jemincare
- Brief Summary
Study to assess the effect of JMKX001899 on QTc interval in healthy volunteers
- Detailed Description
A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Escalation Study to Evaluate the Pharmacokinetics and the Effect on Cardiac Repolarization of JMKX001899 Administered as a Tablet Formulation Under Fed Conditions in Healthy Subjects
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 27
Inclusion Criteria
- Healthy, adult, male or female 18-45 years of age, inclusive.
- Body mass index (BMI) between 19 and 28 kg/m2 (inclusive) and weight at least 50 kg.
- Participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.
Exclusion Criteria
- Patients with a history of clinically significant diseases including, but not limited to, gastrointestinal, renal, liver, neurological, hematological, endocrine, neoplastic, pulmonary, immune, psychiatric, or cardiovascular and cerebrovascular diseases, epilepsy, bipolar disorder/mania, intraocular hypertension, or acute angle-closure glaucoma.
- Female subjects with a positive pregnancy test or lactating.
- Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) or Treponema pallidum（TP-Ab）
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1 JMKX001899 Participants will receive JMKX001899 500 once on Day 1 Cohort 1 Placebo Participants will receive JMKX001899 500 once on Day 1 Cohort 2 Placebo Participants will receive JMKX001899 750 once on Day 1 Cohort 3 Placebo Participants will receive JMKX001899 1000 once on Day 1 Cohort 2 JMKX001899 Participants will receive JMKX001899 750 once on Day 1 Cohort 3 JMKX001899 Participants will receive JMKX001899 1000 once on Day 1
- Primary Outcome Measures
Name Time Method To evaluate the effect of a single dose of JMKX001899 on the change in time-matched QTc intervals compared with placebo 48 hours QTc interval was measured by electrocardiograms to evaluate the potential effect of JMKX001899 plasma concentrations on the QTc interval using linear mixed-effect exposure-response modeling, including the predicted ddQTc at Cmax values corresponding to exposure levels
- Secondary Outcome Measures
Name Time Method