A Study of YP05002 in Healthy Participants

NCT ID: NCT07089823

Last Updated: 2025-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-19

Study Completion Date

2026-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Weight Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SAD Cohort 1

SAD dose 1

Group Type EXPERIMENTAL

YP05002

Intervention Type DRUG

Tablet, QD

Placebo

Intervention Type OTHER

Tablet, QD

SAD Cohort 2

SAD dose 2

Group Type EXPERIMENTAL

YP05002

Intervention Type DRUG

Tablet, QD

Placebo

Intervention Type OTHER

Tablet, QD

SAD Cohort 3

SAD dose 3

Group Type EXPERIMENTAL

YP05002

Intervention Type DRUG

Tablet, QD

Placebo

Intervention Type OTHER

Tablet, QD

SAD Cohort 4

SAD dose 4

Group Type EXPERIMENTAL

YP05002

Intervention Type DRUG

Tablet, QD

Placebo

Intervention Type OTHER

Tablet, QD

SAD Cohort 5

SAD dose 5

Group Type EXPERIMENTAL

YP05002

Intervention Type DRUG

Tablet, QD

Placebo

Intervention Type OTHER

Tablet, QD

MAD Cohort 1

MAD dose 1

Group Type EXPERIMENTAL

YP05002

Intervention Type DRUG

Tablet, QD

Placebo

Intervention Type OTHER

Tablet, QD

MAD Cohort 2

MAD dose 2

Group Type EXPERIMENTAL

YP05002

Intervention Type DRUG

Tablet, QD

Placebo

Intervention Type OTHER

Tablet, QD

MAD Cohort 3

MAD dose 3

Group Type EXPERIMENTAL

YP05002

Intervention Type DRUG

Tablet, QD

Placebo

Intervention Type OTHER

Tablet, QD

Interventions

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YP05002

Tablet, QD

Intervention Type DRUG

Placebo

Tablet, QD

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yaopharma Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nucleus Network Melbourne Clinic

Melbourne, Victoria, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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Yalei Xie

Role: CONTACT

+86 23 63211443

Facility Contacts

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Philip Ryan

Role: primary

+613 8593 9801

Other Identifiers

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YP05002-001

Identifier Type: -

Identifier Source: org_study_id

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