Clinical Study of IBI362 in Healthy Chinese Male Subjects
Clinical Study to Evaluate the Pharmacokinetics and Safety of IBI362 Lyophilized Powder and IBI362 Liquid Formulation in Healthy Chinese Male Subjects
1 other identifier
interventional
24
1 country
1
Brief Summary
This is a study to evaluate the pharmacokinetic characteristics and safety of IBI362 lyophilized powder and IBI362 liquid formulation in healthy Chinese male subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Mar 2021
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2021
CompletedFirst Posted
Study publicly available on registry
February 26, 2021
CompletedStudy Start
First participant enrolled
March 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 9, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 17, 2021
CompletedJuly 8, 2021
March 1, 2021
6 days
February 21, 2021
July 7, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Evaluate the PK parameters of IBI362 in healthy Chinese male subjects
Peak Plasma Concentration (Cmax)
From the first dose of study drug until 8 weeks
Evaluate the PK parameters of IBI362 in healthy Chinese male subjects
Area under the plasma concentration versus time curve (AUC)
From the first dose of study drug until 8 weeks
Secondary Outcomes (1)
Number of Participants With Adverse Events
From the first dose of study drug until 8 weeks
Study Arms (2)
IBI362 liquid formulation
EXPERIMENTALParticipants received single subcutaneous injection of IBI362 liquid formulation
IBI362 lyophilized powder
EXPERIMENTALParticipants received single subcutaneous injection of IBI362 lyophilized powder
Interventions
Eligibility Criteria
You may qualify if:
- years old≤ Healthy males≤45 years old
- kilograms per meter squared (kg/m²)≤Body Mass Index≤26 kg/m²
- Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff
You may not qualify if:
- Subjects who have previously completed or discontinued from this study, or who have used IBI362.
- Abnormal vital signs and physical examination during the screening period;
- Having cardiovascular, respiratory, liver, kidney, digestive, endocrine, hematologic, neurological, or muscle degenerative diseases can significantly affect drug absorption, metabolism, or elimination, or participation in the study increases risk or interferes with data interpretation.
- Have a previous or current mental illness.
- A family history of medullary thyroid carcinoma or multiple endocrine tumor syndrome type 2.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Sceond Affiliated Hospital of Nanchang University
Nanchang, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jian Li
The Sceond Affiliated Hospital of Nanchang University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2021
First Posted
February 26, 2021
Study Start
March 3, 2021
Primary Completion
March 9, 2021
Study Completion
June 17, 2021
Last Updated
July 8, 2021
Record last verified: 2021-03