DRUG
IBI362 liquid formulation
Administered by subcutaneous injection
Status
Completed
Phase
Phase 1
Enrollment
24
Locations
1
Results
Not posted
Publications
0
Study 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.
Pharmacokinetic;Safety
Interventions
DRUG
Administered by subcutaneous injection
DRUG
Administered by subcutaneous injection
Timeline
First posted
Feb 26, 2021
Study start
Mar 3, 2021
Primary completion
Mar 9, 2021
Study completion
Jun 17, 2021
Results posted
Not reported
Registry updated
Jul 8, 2021
Outcomes
Evaluate the PK parameters of IBI362 in healthy Chinese male subjects
Time frame · From the first dose of study drug until 8 weeks
Peak Plasma Concentration (Cmax)
Evaluate the PK parameters of IBI362 in healthy Chinese male subjects
Time frame · From the first dose of study drug until 8 weeks
Area under the plasma concentration versus time curve (AUC)
Number of Participants With Adverse Events
Time frame · From the first dose of study drug until 8 weeks
The relationship of each adverse event to the investigational product was assessed by the investigator.
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.
Study locations
China. Showing up to 24 locations stored in the fast local snapshot.
The Sceond Affiliated Hospital of Nanchang University
Nanchang, China
Publications
No PMID-linked publications were present in this registry snapshot.
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