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

Jemincare

Status and phase: Enrolling; Phase 1

Conditions: Safety and Tolerability

Treatments: Drug: Placebo in Cohorts 1 to 5; Drug: JMKX003002 will be administered orally; Drug: Placebo in 2 Cohorts

Study type: Interventional

Funder types: Industry

Identifiers

NCT05907382

JY-JM3002-101

Details and patient eligibility

About

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

Full description

Pharmacokinetic (PK) parameters, Pharmacodynamics

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 5 patient groups, including a placebo group

JMKX003002 SAD experimental group

Experimental group

Description:

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.

Treatment:

Drug: JMKX003002 will be administered orally

Drug: JMKX003002 will be administered orally

Drug: JMKX003002 will be administered orally

JMKX003002 MAD experimental group

Experimental group

Description:

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.

Treatment:

Drug: JMKX003002 will be administered orally

Drug: JMKX003002 will be administered orally

Drug: JMKX003002 will be administered orally

JMKX003002 FE experimental group

Experimental group

Description:

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

Treatment:

Drug: JMKX003002 will be administered orally

Drug: JMKX003002 will be administered orally

Drug: JMKX003002 will be administered orally

Placebo in Cohorts 1 to 5

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo in Cohorts 1 to 5

Placebo in 2 Cohorts

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo in 2 Cohorts