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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Solid Tumor, Adult
• Intervention / Treatment: Drug: JMKX001899; Drug: JMKX001899; Drug: JMKX001899; Drug: Placebo

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

• Study Type: Interventional
• Enrollment (Estimated): 27
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: WEIXIA LI; Phone Number: +86 15000279084; Email: liweixia@jemincare.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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）

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; Participants will receive JMKX001899 500 once on Day 1	Drug: JMKX001899; Participants will receive JMKX001899 500mg tablet, orally once on Day 1; Drug: JMKX001899; Participants will receive JMKX001899 750mg tablet, orally once on Day 1; Drug: JMKX001899; Participants will receive JMKX001899 1000mg tablet, orally once on Day 1; Drug: Placebo; Participants will receive JMKX001899 matching placebo, tablet, orally once on Day 1
Experimental: Cohort 2; Participants will receive JMKX001899 750 once on Day 1	Drug: JMKX001899; Participants will receive JMKX001899 500mg tablet, orally once on Day 1; Drug: JMKX001899; Participants will receive JMKX001899 750mg tablet, orally once on Day 1; Drug: JMKX001899; Participants will receive JMKX001899 1000mg tablet, orally once on Day 1; Drug: Placebo; Participants will receive JMKX001899 matching placebo, tablet, orally once on Day 1
Experimental: Cohort 3; Participants will receive JMKX001899 1000 once on Day 1	Drug: JMKX001899; Participants will receive JMKX001899 500mg tablet, orally once on Day 1; Drug: JMKX001899; Participants will receive JMKX001899 750mg tablet, orally once on Day 1; Drug: JMKX001899; Participants will receive JMKX001899 1000mg tablet, orally once on Day 1; Drug: Placebo; Participants will receive JMKX001899 matching placebo, tablet, orally once on Day 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	48 hours

Collaborators and Investigators

• Sponsor: Jemincare

Study record dates

Study Major Dates

• Study Start (Estimated): July 10, 2024
• Primary Completion (Estimated): September 24, 2024
• Study Completion (Estimated): February 27, 2025

Study Registration Dates

• First Submitted: June 19, 2024
• First Submitted That Met QC Criteria: June 19, 2024
• First Posted (Actual): June 25, 2024

Study Record Updates

• Last Update Posted (Actual): June 25, 2024
• Last Update Submitted That Met QC Criteria: June 19, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: JY-JM1899-106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No