Overweight/Obesity Clinical Trial
Official title:
Clinical Study to Evaluate the Pharmacokinetics and Safety of IBI362 Lyophilized Powder and IBI362 Liquid Formulation in Healthy Chinese Male Subjects
Verified date | March 2021 |
Source | Innovent Biologics (Suzhou) Co. Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a study to evaluate the pharmacokinetic characteristics and safety of IBI362 lyophilized powder and IBI362 liquid formulation in healthy Chinese male subjects.
Status | Completed |
Enrollment | 24 |
Est. completion date | June 17, 2021 |
Est. primary completion date | March 9, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 20 Years to 45 Years |
Eligibility | Inclusion Criteria: 1. 20 years old= Healthy males=45 years old 2. 19 kilograms per meter squared (kg/m²)=Body Mass Index=26 kg/m² 3. Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff Exclusion Criteria: 1. Subjects who have previously completed or discontinued from this study, or who have used IBI362. 2. Abnormal vital signs and physical examination during the screening period; 3. 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. 4. Have a previous or current mental illness. 5. A family history of medullary thyroid carcinoma or multiple endocrine tumor syndrome type 2. 6. There are other factors judged by the investigators that are not suitable for inclusion in this study. |
Country | Name | City | State |
---|---|---|---|
China | The Sceond Affiliated Hospital of Nanchang University | Nanchang |
Lead Sponsor | Collaborator |
---|---|
Innovent Biologics (Suzhou) Co. Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Number of Participants With Adverse Events | The relationship of each adverse event to the investigational product was assessed by the investigator. | From the first dose of study drug until 8 weeks |
Status | Clinical Trial | Phase | |
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Completed |
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