Study of JMKX003142 Injection in Chinese Healthy Subjects

Jemincare

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy Adult

Treatments: Drug: Placebo; Drug: JMKX003142 Injection

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06344533

JMKX003142iv-101

Details and patient eligibility

About

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

Enrollment: 78 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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78 participants in 2 patient groups, including a placebo group

JMKX003142 Injection

Experimental group

Description:

Single and multiple doses of JMKX003142 Injection administered intravenously.

Treatment:

Drug: JMKX003142 Injection

Placebo

Placebo Comparator group

Description:

Placebo administered intravenously.

Treatment:

Drug: Placebo