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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-10

Study Completion Date

2025-02-27

Brief Summary

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

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Detailed Description

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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

Conditions

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Solid Tumor, Adult

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1

Participants will receive JMKX001899 500 once on Day 1

Group Type EXPERIMENTAL

JMKX001899

Intervention Type DRUG

Participants will receive JMKX001899 500mg tablet, orally once on Day 1

Placebo

Intervention Type DRUG

Participants will receive JMKX001899 matching placebo, tablet, orally once on Day 1

Cohort 2

Participants will receive JMKX001899 750 once on Day 1

Group Type EXPERIMENTAL

JMKX001899

Intervention Type DRUG

Participants will receive JMKX001899 750mg tablet, orally once on Day 1

Placebo

Intervention Type DRUG

Participants will receive JMKX001899 matching placebo, tablet, orally once on Day 1

Cohort 3

Participants will receive JMKX001899 1000 once on Day 1

Group Type EXPERIMENTAL

JMKX001899

Intervention Type DRUG

Participants will receive JMKX001899 1000mg tablet, orally once on Day 1

Placebo

Intervention Type DRUG

Participants will receive JMKX001899 matching placebo, tablet, orally once on Day 1

Interventions

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JMKX001899

Participants will receive JMKX001899 500mg tablet, orally once on Day 1

Intervention Type DRUG

JMKX001899

Participants will receive JMKX001899 750mg tablet, orally once on Day 1

Intervention Type DRUG

JMKX001899

Participants will receive JMKX001899 1000mg tablet, orally once on Day 1

Intervention Type DRUG

Placebo

Participants will receive JMKX001899 matching placebo, tablet, orally once on Day 1

Intervention Type DRUG

Eligibility Criteria

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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）

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes