A Study of YP05002 in Healthy Participants

NCT07089823 | Recruiting Phase 1 DMC

• 1 other identifier: YP05002-001
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Weight Management

Outcome Measures

Primary Outcomes (2)

• Number and percentage of adverse events (AEs), serious adverse events (SAEs) in each dose group during the safety observation period (SAD)

  Up to Day 14

• Number and percentage of adverse events (AEs), serious adverse events (SAEs) in each dose group during the safety observation period (MAD)

  Up to Day 41

Secondary Outcomes (2)

• Cmax of YP05002 (SAD)

  Up to Day 14

• Cmax of YP05002 (MAD)

  Up to Day 41

Study Arms (8)

SAD Cohort 1

EXPERIMENTAL

SAD dose 1

Drug: YP05002; Other: Placebo

SAD Cohort 2

EXPERIMENTAL

SAD dose 2

Drug: YP05002; Other: Placebo

SAD Cohort 3

EXPERIMENTAL

SAD dose 3

Drug: YP05002; Other: Placebo

SAD Cohort 4

EXPERIMENTAL

SAD dose 4

Drug: YP05002; Other: Placebo

SAD Cohort 5

EXPERIMENTAL

SAD dose 5

Drug: YP05002; Other: Placebo

MAD Cohort 1

EXPERIMENTAL

MAD dose 1

Drug: YP05002; Other: Placebo

MAD Cohort 2

EXPERIMENTAL

MAD dose 2

Drug: YP05002; Other: Placebo

MAD Cohort 3

EXPERIMENTAL

MAD dose 3

Drug: YP05002; Other: Placebo

Interventions

YP05002 DRUG

Tablet, QD

MAD Cohort 1; MAD Cohort 2; MAD Cohort 3; SAD Cohort 1; SAD Cohort 2; SAD Cohort 3; SAD Cohort 4; SAD Cohort 5

Placebo OTHER

Tablet, QD

MAD Cohort 1; MAD Cohort 2; MAD Cohort 3; SAD Cohort 1; SAD Cohort 2; SAD Cohort 3; SAD Cohort 4; SAD Cohort 5

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
• Healthy male and female participants aged 18-65 years (both inclusive).No restrictions on race.
• 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.

You may not qualify if:

• Have evidence of any clinically significant active or chronic disease.
• 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.
• 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.
• Any malignancy (except basal cell carcinoma and squamous cell carcinoma of the skin) in the previous 5 years.
• Diagnosis of any type of pancreatitis.

Sponsors & Collaborators

• Yaopharma Co., Ltd.: lead

Study Sites (1)

Nucleus Network Melbourne Clinic

Melbourne, Victoria, 3004, Australia

RECRUITING

Central Study Contacts

Yalei Xie

CONTACT

+86 23 63211443; xieyl@yaopharma.com

Study Design

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

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: July 28, 2025
• Study Start: August 19, 2025
• Primary Completion: April 12, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)