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

Phase 1

Recruiting

• Conditions: Safety and Tolerability
• Interventions: Drug: JMKX003002 will be administered orally; Drug: Placebo in Cohorts 1 to 5; Drug: Placebo in 2 Cohorts

• Registration Number: NCT05907382
• Lead Sponsor: Jemincare

Brief Summary

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

Detailed Description

Pharmacokinetic (PK) parameters, Pharmacodynamics

Study Timeline

• Status Verified: 2023-05
• Study Start: 2023-05-09
• Study First Submitted: 2023-05-23
• Study First Submitted QC: 2023-06-15
• Last Update Submitted: 2023-06-15
• Study First Posted: 2023-06-18
• Last Update Posted: 2023-06-18
• Primary Completion: 2023-12
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
JMKX003002 SAD experimental group	JMKX003002 will be administered orally	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.
JMKX003002 MAD experimental group	JMKX003002 will be administered orally	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.
JMKX003002 FE experimental group	JMKX003002 will be administered orally	Participants will receive 3 Sequence regimens, with a washout period between treatments.
Placebo in Cohorts 1 to 5	Placebo in Cohorts 1 to 5	Participants in Cohorts 1 to 5 will receive single oral dose of matching placebo on Day 1.
Placebo in 2 Cohorts	Placebo in 2 Cohorts	Participants in 2 Cohorts will receive orally twice -daily of matching placebo for 7 consecutive days.

Primary Outcome Measures

Name	Time	Method
Number of the Adverse Events that are related to the single dose treatment	from baseline to Day 11	single dose safety
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

Trial Locations

Locations (1)

Huashan Hospital Fudan University; 🇨🇳 Shanghai, Shanghai, China