Study of JMKX003142 Injection in Chinese Healthy Subjects

Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of JMKX003142 Injection Administered Randomly, Double-blind, Placebo-controlled, Single-ascending Dose and Multiple-ascending Doses in Chinese Healthy Adult Subjects

To Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of JMKX003142 Injection Administered Randomly, Double-blind, Placebo-controlled, Single-ascending Dose and Multiple-ascending Doses in Chinese Healthy Adult Subjects

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Adult
• Intervention / Treatment: Drug: JMKX003142 Injection; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 78
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yiming Dong, MD; Phone Number: 021-58306003; Email: dongyiming@jemincare.com
• Study Contact Backup: Name: Haiyan Li, MD; Phone Number: 010-82266226; Email: haiyanli1027@hotmail.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital
      • Principal Investigator: Haiyan Li, MD
      • Contact: Haiyan Li
      • Principal Investigator: Dongyang Liu, PhD

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Male and female subjects aged 18-45 years (including boundary values).
2. Able to sign a written informed consent form.
3. Physical examination, clinical laboratory examination value, Virology examination, vital signs and ECG examination are confirmed by the researcher to be normal or abnormal without clinical significance
4. The subjects have a thorough understanding of the study content, process, and potential adverse effects, and are willing to complete the study according to the requirements of the experimental protocol

Exclusion Criteria:

1. Had or currently have serious clinical diseases related to circulatory system, respiratory system, digestive system, nervous system, endocrine system, blood lymphatic system, genitourinary system or psychiatry, as well as habitual constipation, gastrointestinal bleeding history, which is judged to be inappropriate for the study by the investigators
2. Participants in any other clinical study within 3 months prior to the first administration of this study
3. The investigators believe that the subject has other factors that are not suitable for participating in this experiment
4. Pregnant or lactating women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JMKX003142 Injection; Single and multiple doses of JMKX003142 Injection administered intravenously.	Drug: JMKX003142 Injection; JMKX003142 Injection will be administered intravenously once in SAD cohorts and once daily in MAD cohorts for 5 consecutive days.
Placebo Comparator: Placebo; Placebo administered intravenously.	Drug: Placebo; Matching placebo will be administered intravenously once in SAD cohorts and once daily in MAD cohorts for 5 consecutive days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of the Adverse Events that are related to the single dose treatment	single dose safety single dose safety	From Baseline to Day7
Number of the Adverse Events that are related to the multiple dose treatment	multiple dose safety multiple dose safety	From Baseline to Day12

Collaborators and Investigators

• Sponsor: Jemincare
• Collaborators: Zhejiang Hangyu Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): April 10, 2024
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): May 30, 2025

Study Registration Dates

• First Submitted: March 18, 2024
• First Submitted That Met QC Criteria: March 27, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: JMKX003142iv-101

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