Phase 1 Clinical Study of JMKX003142 Tablets

Safety and Tolerability Clinical Trial

Official title:

Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of JMKX003142 Tablets Administered Randomly, Double-blind, Placebo-controlled Single and Multiple Times in Healthy Adult Subjects, as Well as the Effects of Randomized, Open, and Two Cycle Crossover Foods

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06079541
• Other study ID #: JY-JM-035-101
• Status: Recruiting
• Phase: Phase 1
• Start date: July 6, 2023
• Est. completion date: March 30, 2025

Study information

• Verified date: July 2023
• Source: Jemincare
• Contact: jianping Su
• Phone: +86 15162481262
• Email: sujianping[@]jemincare.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of JMKX003142 tablets administered randomly, double-blind, placebo-controlled single and multiple times in healthy adult subjects, as well as the effects of randomized, open, and two cycle crossover foods

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: March 30, 2025
• Est. primary completion date: July 31, 2024
• 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 12 lead 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

• Safety and Tolerability

Intervention

Drug:
• JMKX003142 will be administered orally
oral once
• JMKX003142 will be administered orally
oral once
• JMKX003142 will be administered orally
oral once
• Placebo in Cohorts 1 to 7
oral once
• Placebo in 3 Cohorts
oral once

Locations

Country	Name	City	State
China	Zhongshan Hospital, Fudan University	Shanghai	Shanghai

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	from baseline to Day 18
Primary	Number of the Adverse Events that are related to the multiple dose treatment from	multiple dose safety	from baseline to Day 24