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

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

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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