A Study to Evaluate Safety, Tolerability and pK of Semaglutide ER Injectable Suspension in Healthy, Adult Human Subjects
NCT06422624 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14
Last updated 2024-05-22
Summary
The purpose of the trail is to evaluate the safety, tolerability and pharmacokinetics of a single escalated doses of semaglutide extended-release injectable suspension in healthy adult, human study participants under fasting condition.
Conditions
- Diabetes Mellitus, Type 2
Interventions
- DRUG
-
Semaglutide Extended-release for Injectable Suspension, 1 mg
Singel-dose; Subcutaneous
- DRUG
-
Semaglutide Extended-release for Injectable Suspension, 4 mg
Singel-dose; Subcutaneous
- DRUG
-
Semaglutide Extended-release for Injectable Suspension, 8 mg
Singel-dose; Subcutaneous
Sponsors & Collaborators
-
Bostal Drug Delivery Co., Ltd
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-08-31
- Primary Completion
- 2024-11-30
- Completion
- 2024-11-30
- FDA Drug
- Yes
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