Trial of JMKX003801 in Healthy Participants

NCT06549309 | Recruiting Phase 1 DMC

• 1 other identifier: JMKX003801-101
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Safety; Tolerability; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Adverse events (AEs)

  Incidence and features of AEs

  From baseline to Day 3

Secondary Outcomes (1)

• Serum concentrations of JMKX003801

  From baseline to Day 3

Study Arms (2)

Experimental

ACTIVE COMPARATOR

JMKX003801

Drug: JMKX003801

Placebo Comparator

PLACEBO COMPARATOR

Normal saline

Drug: Placebo

Interventions

JMKX003801 DRUG

For Ascending Single Dose of JMKX003801，Five（5）cohorts of 40 participants (each cohort contains 6 active and 2 placebo) are planned for evaluation. For Ascending Multiple Dose of JMKX003801，Three（3）cohort of 30 participants (each cohort contains 8 active and 2 placebo) are planned for evaluation.

Experimental

Placebo DRUG

For Ascending Single Dose of JMKX003801，Five（5）cohorts of 40 participants (each cohort contains 6 active and 2 placebo) are planned for evaluation. For Ascending Multiple Dose of JMKX003801，Three（3）cohorts of 30 participants (each cohort contains 8 active and 2 placebo) are planned for evaluation.

Placebo Comparator

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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) .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jemincare: lead

Study Sites (1)

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, China

RECRUITING

Study Officials

• Jing Zhang

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongzhang Ji

CONTACT

+8618261053520; jihongzhang@jemincare.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 12, 2024
• Study Start: August 17, 2024
• Primary Completion: May 31, 2025
• Study Completion: June 12, 2025
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)