Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of LP-98 Injection in Healthy Subjects
NCT05933824 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2026-05-15
Summary
A randomized, placebo-controlled, single-administration, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of LP-98 injection in healthy subjects in a first-in-human clinical study
Conditions
- HIV (Human Immunodeficiency Virus)
Interventions
- DRUG
-
LP-98 injection
Part A is administration is by subcutaneous LP98/placebo,Part B is administration is by intravenous drip LP98/placebo
Sponsors & Collaborators
-
Institute of Pathogen Biology, Beijing, China
collaborator OTHER -
Shanxi Kangbao Biological Product Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Shuang Li, Master · Henan Provincial Hospital for Infectious Diseases (Zhengzhou Sixth People's Hospital)
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-07-13
- Primary Completion
- 2024-04-12
- Completion
- 2024-04-12
Countries
- China
Study Locations
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