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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07089823




Registration number
NCT07089823
Ethics application status
Date submitted
25/07/2025
Date registered
28/07/2025
Date last updated
6/08/2025

Titles & IDs
Public title
A Study of YP05002 in Healthy Participants
Scientific title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of YP05002 in Healthy Participants
Secondary ID [1] 0 0
YP05002-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Weight Management 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - YP05002
Other interventions - Placebo

Experimental: SAD Cohort 1 - SAD dose 1

Experimental: SAD Cohort 2 - SAD dose 2

Experimental: SAD Cohort 3 - SAD dose 3

Experimental: SAD Cohort 4 - SAD dose 4

Experimental: SAD Cohort 5 - SAD dose 5

Experimental: MAD Cohort 1 - MAD dose 1

Experimental: MAD Cohort 2 - MAD dose 2

Experimental: MAD Cohort 3 - MAD dose 3


Treatment: Drugs: YP05002
Tablet, QD

Other interventions: Placebo
Tablet, QD
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number and percentage of adverse events (AEs), serious adverse events (SAEs) in each dose group during the safety observation period (SAD)
Timepoint [1] 0 0
Up to Day 14
Primary outcome [2] 0 0
Number and percentage of adverse events (AEs), serious adverse events (SAEs) in each dose group during the safety observation period (MAD)
Timepoint [2] 0 0
Up to Day 41
Secondary outcome [1] 0 0
Cmax of YP05002 (SAD)
Timepoint [1] 0 0
Up to Day 14
Secondary outcome [2] 0 0
Cmax of YP05002 (MAD)
Timepoint [2] 0 0
Up to Day 41

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
19/08/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
76
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Melbourne Clinic - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Yaopharma Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Yalei Xie
Address 0 0
Country 0 0
Phone 0 0
+86 23 63211443
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07089823