Study of JMKX003142 Injection in Chinese Healthy Subjects

NCT ID: NCT06344533

Last Updated: 2024-04-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-10
• Study Completion Date: 2025-05-30

Brief 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

Conditions

Healthy Adult

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

JMKX003142 Injection

Single and multiple doses of JMKX003142 Injection administered intravenously.

Group Type: EXPERIMENTAL

JMKX003142 Injection

Intervention Type: DRUG

JMKX003142 Injection will be administered intravenously once in SAD cohorts and once daily in MAD cohorts for 5 consecutive days.

Placebo

Placebo administered intravenously.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo will be administered intravenously once in SAD cohorts and once daily in MAD cohorts for 5 consecutive days.

Interventions

JMKX003142 Injection

JMKX003142 Injection will be administered intravenously once in SAD cohorts and once daily in MAD cohorts for 5 consecutive days.

Intervention Type: DRUG

Placebo

Matching placebo will be administered intravenously once in SAD cohorts and once daily in MAD cohorts for 5 consecutive days.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zhejiang Hangyu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Jemincare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University Third Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Yiming Dong, MD

Role: CONTACT

dongyiming@jemincare.com

021-58306003

Haiyan Li, MD

Role: CONTACT

haiyanli1027@hotmail.com

010-82266226

Facility Contacts

Haiyan Li

Role: primary

Other Identifiers

JMKX003142iv-101

Identifier Type: -

Identifier Source: org_study_id