A Trial to Evaluate the Safety Tolerability and Pharmacokinetics of B1344 by Subcutaneous Injection in Healthy Subjects
NCT05655221 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56
Last updated 2022-12-19
Summary
To evaluate the safety, tolerability, and immunogenicity of B1344 by single subcutaneous (s.c.) injection in healthy subjects
Conditions
Interventions
- DRUG
-
B1344
multi-site abdominal s.c. injections (maximum 2 mL at each site)
- OTHER
-
Placebo
multi-site abdominal s.c. injections (maximum 2 mL at each site)
Sponsors & Collaborators
-
Tasly Biopharmaceuticals Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Kongli Zhu, MD · Tasly Biopharmaceuticals Co., Ltd.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-08-30
- Primary Completion
- 2023-07-31
- Completion
- 2024-01-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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