A Study of YP05002 in Healthy Participants
ConditionWeight Management
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorYaopharma Co., Ltd.
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
YP05002
DrugTablet, QD
Placebo
Other interventionTablet, QD
Treatment groups
76 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Group A: SAD Cohort 1Experimental treatment 2 interventions
Group B: SAD Cohort 2Experimental treatment 2 interventions
Group C: SAD Cohort 3Experimental treatment 2 interventions
Group D: SAD Cohort 4Experimental treatment 2 interventions
Group E: SAD Cohort 5Experimental treatment 2 interventions
Group F: MAD Cohort 1Experimental treatment 2 interventions
Group G: MAD Cohort 2Experimental treatment 2 interventions
Group H: MAD Cohort 3Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Number and percentage of adverse events (AEs), serious adverse events (SAEs) in each dose group during the safety observation period (SAD)
Time frame
Up to Day 142
Number and percentage of adverse events (AEs), serious adverse events (SAEs) in each dose group during the safety observation period (MAD)
Time frame
Up to Day 41Secondary outcomes
1
Cmax of YP05002 (SAD)
PK parameters of YP05002
Time frame
Up to Day 142
Cmax of YP05002 (MAD)
PK parameters of YP05002
Time frame
Up to Day 41Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov