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

NCT05907382 | Unknown Phase 1

• 1 other identifier: JY-JM3002-101
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Safety and Tolerability

Outcome Measures

Primary Outcomes (2)

• Number of the Adverse Events that are related to the single dose treatment

  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

  multiple dose safety

  from baseline to Day 18

Study Arms (5)

JMKX003002 SAD experimental group

EXPERIMENTAL

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

JMKX003002 MAD experimental group

EXPERIMENTAL

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

JMKX003002 FE experimental group

EXPERIMENTAL

Participants will receive 3 Sequence regimens, with a washout period between treatments.

Drug: JMKX003002 will be administered orally

Placebo in Cohorts 1 to 5

PLACEBO COMPARATOR

Participants in Cohorts 1 to 5 will receive single oral dose of matching placebo on Day 1.

Drug: Placebo in Cohorts 1 to 5

Placebo in 2 Cohorts

PLACEBO COMPARATOR

Participants in 2 Cohorts will receive orally twice -daily of matching placebo for 7 consecutive days.

Drug: Placebo in 2 Cohorts

Interventions

JMKX003002 will be administered orally DRUG

oral once

Also known as: JMKX003002

JMKX003002 SAD experimental group

Placebo in Cohorts 1 to 5 DRUG

oral once

Also known as: Matching placebo will be administered orally

Placebo in Cohorts 1 to 5

Placebo in 2 Cohorts DRUG

oral once

Also known as: Matching placebo will be administered orally

Placebo in 2 Cohorts

Eligibility Criteria

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

You may qualify if:

• Male or female subjects aged 18-45 years (inclusive);-
• 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;
• Subjects who understand study procedures and methods, voluntarily participate in this trial, follow study-related instructions, and sign a written informed consent form.

You may not qualify if:

• 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
• Subjects with history of or current malignancy;
• Participant who the researchers believe that there are volunteers who are not suitable for

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

Jing Xu

CONTACT

021-52887926; xujing2@jimincare.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: June 18, 2023
• Study Start: May 9, 2023
• Primary Completion: December 1, 2023
• Study Completion: March 1, 2024
• Last Updated: June 18, 2023

Record last verified: 2023-05

Locations

CN (1)