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Trial Title:
To Assess the Effects of Single Dose of JMKX001899 on QTc Interval in Healthy Subjects
NCT ID:
NCT06473948
Condition:
Solid Tumor, Adult
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Basic Science
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
JMKX001899
Description:
Participants will receive JMKX001899 500mg tablet, orally once on Day 1
Arm group label:
Cohort 1
Intervention type:
Drug
Intervention name:
JMKX001899
Description:
Participants will receive JMKX001899 750mg tablet, orally once on Day 1
Arm group label:
Cohort 2
Intervention type:
Drug
Intervention name:
JMKX001899
Description:
Participants will receive JMKX001899 1000mg tablet, orally once on Day 1
Arm group label:
Cohort 3
Intervention type:
Drug
Intervention name:
Placebo
Description:
Participants will receive JMKX001899 matching placebo, tablet, orally once on Day 1
Arm group label:
Cohort 1
Arm group label:
Cohort 2
Arm group label:
Cohort 3
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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Healthy, adult, male or female 18-45 years of age, inclusive.
2. Body mass index (BMI) between 19 and 28 kg/m2 (inclusive) and weight at least 50 kg.
3. 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:
1. 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.
2. Female subjects with a positive pregnancy test or lactating.
3. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B
surface antigen (HBsAg), hepatitis C virus (HCV) or Treponema pallidum（TP-Ab）
Gender:
All
Minimum age:
18 Years
Maximum age:
45 Years
Healthy volunteers:
Accepts Healthy Volunteers
Start date:
July 10, 2024
Completion date:
February 27, 2025
Lead sponsor:
Agency:
Jemincare
Agency class:
Industry
Source:
Jemincare
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06473948
