Study of JMKX003142 Injection in Chinese Healthy Subjects

Healthy Adult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06344533
• Other study ID #: JMKX003142iv-101
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: April 10, 2024
• Est. completion date: May 30, 2025

Study information

• Verified date: March 2024
• Source: Jemincare
• Contact: Yiming Dong, MD
• Phone: 021-58306003
• Email: dongyiming[@]jemincare.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 78
• Est. completion date: May 30, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Adult

Intervention

Drug:
• JMKX003142 Injection
JMKX003142 Injection will be administered intravenously once in SAD cohorts and once daily in MAD cohorts for 5 consecutive days.
• Placebo
Matching placebo will be administered intravenously once in SAD cohorts and once daily in MAD cohorts for 5 consecutive days.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Jemincare	Zhejiang Hangyu Pharmaceutical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of the Adverse Events that are related to the single dose treatment	single dose safety single dose safety	From Baseline to Day7
Primary	Number of the Adverse Events that are related to the multiple dose treatment	multiple dose safety multiple dose safety	From Baseline to Day12