To Assess the Effects of Single Dose of JMKX001899 on QTc Interval in Healthy Subjects
A Phase 1, Single Center, Randomized, Double-Blind, Placebo-Controlled, Single-Dose Study to Evaluate the Effect of JMKX001899 on the QTc Interval in Healthy Subjects
1 other identifier
interventional
27
0 countries
N/A
Brief Summary
Study to assess the effect of JMKX001899 on QTc interval in healthy volunteers
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jul 2024
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2024
CompletedFirst Posted
Study publicly available on registry
June 25, 2024
CompletedStudy Start
First participant enrolled
July 10, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 24, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 27, 2025
CompletedJune 25, 2024
June 1, 2024
3 months
June 19, 2024
June 19, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
To evaluate the effect of a single dose of JMKX001899 on the change in time-matched QTc intervals compared with placebo
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
48 hours
Study Arms (3)
Cohort 1
EXPERIMENTALParticipants will receive JMKX001899 500 once on Day 1
Cohort 2
EXPERIMENTALParticipants will receive JMKX001899 750 once on Day 1
Cohort 3
EXPERIMENTALParticipants will receive JMKX001899 1000 once on Day 1
Interventions
Participants will receive JMKX001899 matching placebo, tablet, orally once on Day 1
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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）
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jemincarelead
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2024
First Posted
June 25, 2024
Study Start
July 10, 2024
Primary Completion
September 24, 2024
Study Completion
February 27, 2025
Last Updated
June 25, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share