Trial of JMKX003801 in Healthy Participants

Jemincare

Status and phase: Enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: JMKX003801; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06549309

JMKX003801-101

Details and patient eligibility

About

To Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of JMKX003801 Administered Randomly, Double-blind, Placebo-controlled, Single-ascending Dose and Multiple-ascending Dose in Chinese Healthy Adult Participants

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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;
• Healthy adult males and/or females, 18 to 45 years of age;
• Body mass index (BMI) ≥ 19 and ≤ 28.0 (kg/m2) ,weight ≥45kg (female) or ≥50kg (male) .

Exclusion criteria

• 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, or any other diseases judged by investigators that will be interference to the results of this study;
• Use of any over-the-counter (OTC) medication, prescription medicine, Chinese herbal medicine , within 2 weeks prior to the time of informed consent signed;
• Pregnant or lactating women;
• Other conditions unsuitable for the trial judged by the investigators.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups, including a placebo group

Experimental

Active Comparator group

Description:

JMKX003801

Treatment:

Drug: JMKX003801

Placebo Comparator

Placebo Comparator group

Description:

Normal saline

Treatment:

Drug: Placebo