Safety, Tolerability of JMKX003002 in Phase 1 Study in Healthy Subjects

June 15, 2023 updated by: Jemincare

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JMKX003002 in Single and Multiple Ascending Dose Randomized，Doubled-blind Phase 1 Study in Healthy Subjects

Safety, tolerability, pharmacokinetics, and pharmacodynamics of JMKX003002 in single and multiple ascending dose randomized，doubled-blind phase 1 study in healthy subjects

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Pharmacokinetic (PK) parameters, Pharmacodynamics

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Huashan Hospital Fudan University
        • Contact:
          • Jing Zhang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Male or female subjects aged 18-45 years (inclusive);-
  2. With normal or abnormal but clinically insignificant comprehensive physical examination (vital signs, physical examination), laboratory tests (hematology, blood biochemistry, urinalysis, coagulation function test) and, 12-lead ECG;
  3. Subjects who understand study procedures and methods, voluntarily participate in this trial, follow study-related instructions, and sign a written informed consent form.

Exclusion Criteria:

  1. Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematologic, metabolic, endocrine, neurologic, psychiatric disease, or any condition that may interfere with the subject successfully completing the trial
  2. Subjects with history of or current malignancy;
  3. Participant who the researchers believe that there are volunteers who are not suitable for

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: JMKX003002 SAD experimental group
Participants will be randomized into 5 cohorts to receive single oral dose of JMKX003002 on Day 1. The doses in each cohort will be escalated based on the safety and pharmacokinetics (PK) / Pharmacodynamics (PD) data of the previous cohort.
Drug: JMKX003002 will be administered orally
oral once
Other Names:
  • JMKX003002
Experimental: JMKX003002 MAD experimental group
Participants will be randomized into 2 cohorts to receive orally twice -daily of JMKX003002 for 7 consecutive days. The second cohort will be escalated based on the safety and pharmacokinetics (PK)/ Pharmacodynamics (PD) data of the previous cohort.
Drug: JMKX003002 will be administered orally
oral once
Other Names:
  • JMKX003002
Experimental: JMKX003002 FE experimental group
Participants will receive 3 Sequence regimens, with a washout period between treatments.
Drug: JMKX003002 will be administered orally
oral once
Other Names:
  • JMKX003002
Placebo Comparator: Placebo in Cohorts 1 to 5
Participants in Cohorts 1 to 5 will receive single oral dose of matching placebo on Day 1.
Drug: Placebo in Cohorts 1 to 5
oral once
Other Names:
  • Matching placebo will be administered orally
Placebo Comparator: Placebo in 2 Cohorts
Participants in 2 Cohorts will receive orally twice -daily of matching placebo for 7 consecutive days.
Drug: Placebo in 2 Cohorts
oral once
Other Names:
  • Matching placebo will be administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of the Adverse Events that are related to the single dose treatment
Time Frame: from baseline to Day 11
single dose safety
from baseline to Day 11
Number of the Adverse Events that are related to the multiple dose treatment from baseline to Day 18
Time Frame: from baseline to Day 18
multiple dose safety
from baseline to Day 18

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jemincare

Investigators

  • Principal Investigator: Jing Zhang, Huashan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2023

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

May 23, 2023

First Submitted That Met QC Criteria

June 15, 2023

First Posted (Estimated)

June 16, 2023

Study Record Updates

Last Update Posted (Estimated)

June 16, 2023

Last Update Submitted That Met QC Criteria

June 15, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • JY-JM3002-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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