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

J

Jemincare

Status and phase

Not yet enrolling
Phase 1

Conditions

Solid Tumor, Adult

Treatments

Drug: JMKX001899
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT06473948
JY-JM1899-106

Details and patient eligibility

About

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

Full 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

Enrollment

27 estimated patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

27 participants in 3 patient groups

Cohort 1
Experimental group
Description:
Participants will receive JMKX001899 500 once on Day 1
Treatment:
Drug: Placebo
Drug: JMKX001899
Drug: JMKX001899
Drug: JMKX001899
Cohort 2
Experimental group
Description:
Participants will receive JMKX001899 750 once on Day 1
Treatment:
Drug: Placebo
Drug: JMKX001899
Drug: JMKX001899
Drug: JMKX001899
Cohort 3
Experimental group
Description:
Participants will receive JMKX001899 1000 once on Day 1
Treatment:
Drug: Placebo
Drug: JMKX001899
Drug: JMKX001899
Drug: JMKX001899

Trial contacts and locations

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Central trial contact

WEIXIA LI

Data sourced from clinicaltrials.gov

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