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NCT Number: NCT06549309

Trial of JMKX003801 in Healthy Participants

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

Recruiting

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Location status: Recruiting

Location contact

Jing Zhang

CONTACT

[email protected]

+8613816357098

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Adverse events (AEs)

    Time frame: From baseline to Day 3

    Incidence and features of AEs

Secondary outcomes

  1. Serum concentrations of JMKX003801

    Time frame: From baseline to Day 3

    Serum concentrations of JMKX003801

Study contacts

Contact information is provided by the study sponsor or research team.

Hongzhang Ji

CONTACT

[email protected]

+8618261053520

Sponsors and collaborators

Lead sponsor

Jemincare

Industry

Registry information

Official study title

A Phase I, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics of JMKX003801 in Healthy Participants

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 12, 2024
Registry last updated
Sep 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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