Clinical Study of IBI362 in Healthy Chinese Male Subjects
NCT ID: NCT04773977
Last Updated: 2021-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2021-03-03
2021-06-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IBI362 liquid formulation
Participants received single subcutaneous injection of IBI362 liquid formulation
IBI362 liquid formulation
Administered by subcutaneous injection
IBI362 lyophilized powder
Participants received single subcutaneous injection of IBI362 lyophilized powder
IBI362 lyophilized powder
Administered by subcutaneous injection
Interventions
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IBI362 liquid formulation
Administered by subcutaneous injection
IBI362 lyophilized powder
Administered by subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
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
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.
20 Years
45 Years
MALE
Yes
Sponsors
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Innovent Biologics (Suzhou) Co. Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Jian Li
Role: PRINCIPAL_INVESTIGATOR
The Sceond Affiliated Hospital of Nanchang University
Locations
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The Sceond Affiliated Hospital of Nanchang University
Nanchang, , China
Countries
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Other Identifiers
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CIBI362B102
Identifier Type: -
Identifier Source: org_study_id
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