Clincosm LogoSign in Get a demo

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

Sponsor
Jemincare (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05907382
Collaborator
(none)
80
Enrollment
1
Location
5
Arms
9.8
Anticipated Duration (Months)
8.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: JMKX003002 will be administered orally
  • Drug: JMKX003002 will be administered orally
  • Drug: JMKX003002 will be administered orally
  • Drug: Placebo in Cohorts 1 to 5
  • Drug: Placebo in 2 Cohorts
 Phase 1

Detailed Description

Pharmacokinetic (PK) parameters, Pharmacodynamics

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JMKX003002 in Single and Multiple Ascending Dose Randomized，Doubled-blind Phase 1 Study in Healthy Subjects
Actual Study Start Date :
May 9, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of the Adverse Events that are related to the single dose treatment [from baseline to Day 11]

      single dose safety

    2. Number of the Adverse Events that are related to the multiple dose treatment from baseline to Day 18 [from baseline to Day 18]

      multiple dose safety

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Huashan Hospital Fudan University Shanghai Shanghai China

    Sponsors and Collaborators

    • Jemincare

    Investigators

    • Principal Investigator: Jing Zhang, Huashan Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jemincare
    ClinicalTrials.gov Identifier:
    NCT05907382
    Other Study ID Numbers:
    • JY-JM3002-101
    First Posted:
    Jun 18, 2023
    Last Update Posted:
    Jun 18, 2023
    Last Verified:
    May 1, 2023
    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

    Study Results

    No Results Posted as of Jun 18, 2023