NCT05274659

A Study to Evaluate the Safety and Tolerability of KJ103 in Healthy Adults

A Randomized, Single-blinded, Placebo Controlled, Single Ascending Dose Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of KJ103 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Shanghai Bao Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, single-blinded, placebo controlled, single ascending dose phase I study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) and immunogenicity of KJ103 in healthy subjects.

Detailed description

This single ascending dose (SAD), randomized, single-blinded, placebo controlled study is the first study and it is designed to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of KJ103 in healthy subjects after a single intravenous dose. It will include up to 34 healthy subjects in up to five dose groups.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	KJ103	Recombinant Immunoglobulin G Cleaving Enzyme
DRUG	Placebo	Placebo

Timeline

• Start date: 2022-05-19
• Primary completion: 2023-03-18
• Completion: 2023-08-18
• First posted: 2022-03-10
• Last updated: 2024-08-13

Locations

1 site across 1 country: New Zealand