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

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06473948

Enrollment

Registered

2024-06-25

Start date

2024-07-10

Completion date

2025-02-27

Last updated

2024-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumor, Adult

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

Interventions

DRUGJMKX001899

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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）

Design outcomes

Primary

Measure	Time frame	Description
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

Contacts

Primary ContactWEIXIA LI

liweixia@jemincare.com15000279084

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026