NCT05017168

To Evaluate the Safety, Tolerability and Pharmacokinetics of CT-P63 in Healthy Subjects

A Phase 1, Randomized, Double-blind, Placebo-controlled, Parallel Group, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of CT-P63 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Celltrion · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This is a Phase I study that randomized, double-blind, Placebo-controlled, Parallel Group, Single Ascending Dose Study to evaluate Safety, Tolerability and Pharmacokinetics of CT-P63 in Healthy Subjects.

Detailed description

CT-P63 is a monoclonal antibody targeted against SARS-CoV-2 spike RBD as a treatment for SARS CoV 2 infection. CT-P63 is currently being developed by the Sponsor as a potential treatment for SARS-CoV-2 infection. In this study, safety, tolerability, and pharmacokinetics of CT-P63 will be evaluated in healthy subjects.

Conditions

• SARS-CoV-2 Infection

Interventions

Type	Name	Description
DRUG	CT-P63	CT-P63 will be administered
DRUG	Placebo	Placebo-matching CT-P63

Timeline

• Start date: 2021-10-11
• Primary completion: 2021-11-12
• Completion: 2022-01-25
• First posted: 2021-08-23
• Last updated: 2022-08-11

Locations

1 site across 1 country: Poland