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Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of LP-98 Injection in Healthy Subjects

Hiv Clinical Trial

Official title:
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

Clinical Trial 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

Clinical Trial Description

The study was divided into two parts, Part A and Part B. The Part A and Part B studies were carried out separately according to the protocol flow, with the Part A study carried out first. 1. Part A is set up with 5 cohorts(5mg, 10mg, 20mg, 40mg, 80mg), administration is by subcutaneous, each subject entered only one cohort to receive the drug. 4 subjects were included in cohort 1, and 8 subjects were planned to be included in each cohort 2 to 5, to observe the safety, tolerability, PK and ADA of LP-98 injection by subcutaneous. 2. Part B is set up with 6 cohorts (5mg,10mg,20mg,40mg,80mg, 160mg), administration is by intravenous drip, each subject entered only one cohort to receive the drug. 4 subjects were included in cohort 1, and 8 subjects were planned to be included in each cohort 2 to 6, to observe the safety, tolerability, PK and ADA of LP-98 injection by intravenous drip. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05933824
Study type Interventional
Source Shanxi Kangbao Biological Product Co., Ltd.
Contact xian Yu He, Doctor
Phone +8613126823610
Email yhe@ipb.pumc.edu.cn
Status Recruiting
Phase Phase 1
Start date July 13, 2023
Completion date December 30, 2023
View Details
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