To Assess the Effects of Single Dose of JMKX001899 on QTc Interval in Healthy Subjects

ConditionSolid Tumor, Adult

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-45

SponsorJemincare

About this trial

Study to assess the effect of JMKX001899 on QTc interval in healthy volunteers

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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）

Trial design

Design model

Parallel

Treatments tested in this trial

JMKX001899
Drug
Participants will receive JMKX001899 500mg tablet, orally once on Day 1
JMKX001899
Drug
Participants will receive JMKX001899 750mg tablet, orally once on Day 1
JMKX001899
Drug
Participants will receive JMKX001899 1000mg tablet, orally once on Day 1
Placebo
Drug
Participants will receive JMKX001899 matching placebo, tablet, orally once on Day 1

Treatment groups

27 Participants

are divided into 3 treatment groups

Group A: Cohort 1Experimental treatment 2 interventions

Group B: Cohort 2Experimental treatment 2 interventions

Group C: Cohort 3Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

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

Time frame

48 hours

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jemincare

Lead sponsor

Source ClinicalTrials.gov

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