NCT05933824

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Shanxi Kangbao Biological Product Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• Hiv

Interventions

Type	Name	Description
DRUG	LP-98 injection	Part A is administration is by subcutaneous LP98/placebo,Part B is administration is by intravenous drip LP98/placebo

Timeline

• Start date: 2023-07-13
• Primary completion: 2024-04-12
• Completion: 2024-04-12
• First posted: 2023-07-06
• Last updated: 2024-08-16

Locations

1 site across 1 country: China