A Study of YP05002 in Healthy Participants

Yaopharma Co., Ltd.

Status and phase: Enrolling; Phase 1

Conditions: Weight Management

Treatments: Other: Placebo; Drug: YP05002

Study type: Interventional

Funder types: Industry

Identifiers

NCT07089823

YP05002-001

Details and patient eligibility

About

This is a phase I, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, efficacy, food effect of YP05002 Tablets in healthy participants

Enrollment: 76 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
2. Healthy male and female participants aged 18-65 years (both inclusive).No restrictions on race.
3. In good health as determined by the Investigator, with no clinically significant findings from medical/psychiatric history, physical examination, 12-lead ECG, vital signs measurements, clinical laboratory evaluations.

Exclusion criteria

1. Have evidence of any clinically significant active or chronic disease.
2. Histories of using drug that affect drug absorption, distribution, metabolism, or excretion within 14 days or within 5-half-life prior to the first dose (whichever is longer); gastrointestinal disorders with impaired gastric emptying; or prolonged use of medications that directly modulate gastrointestinal motility.
3. Had clinically relevant acute or chronic medical conditions or diseases that would pose a risk to participant's safety or interfere with the study assessments, as determined by the Investigator.
4. Any malignancy (except basal cell carcinoma and squamous cell carcinoma of the skin) in the previous 5 years.
5. Diagnosis of any type of pancreatitis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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76 participants in 8 patient groups

SAD Cohort 1

Experimental group

Description:

SAD dose 1

Treatment:

Drug: YP05002

Other: Placebo

SAD Cohort 2

Experimental group

Description:

SAD dose 2

Treatment:

Drug: YP05002

Other: Placebo

SAD Cohort 3

Experimental group

Description:

SAD dose 3

Treatment:

Drug: YP05002

Other: Placebo

SAD Cohort 4

Experimental group

Description:

SAD dose 4

Treatment:

Drug: YP05002

Other: Placebo

SAD Cohort 5

Experimental group

Description:

SAD dose 5

Treatment:

Drug: YP05002

Other: Placebo

MAD Cohort 1

Experimental group

Description:

MAD dose 1

Treatment:

Drug: YP05002

Other: Placebo

MAD Cohort 2

Experimental group

Description:

MAD dose 2

Treatment:

Drug: YP05002

Other: Placebo

MAD Cohort 3

Experimental group

Description:

MAD dose 3

Treatment:

Drug: YP05002

Other: Placebo