NCT04525079

To Evaluate the Safety, Tolerability and Pharmacokinetics of CT-P59 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-P59 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Celltrion · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Not 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-P59 in Healthy Subjects.

Detailed description

CT-P59 is a monoclonal antibody targeted against SARS-CoV-2 spike RBD as a treatment for SARS CoV 2 infection. CT-P59 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-P59 will be evaluated in healthy subjects.

Conditions

• SARS-CoV-2 Infection

Interventions

Type	Name	Description
DRUG	CT-P59	CT-P59 will be administered
DRUG	Placebo	Placebo-matching CT-P59

Timeline

• Start date: 2020-07-18
• Primary completion: 2020-08-07
• Completion: 2020-11-05
• First posted: 2020-08-25
• Last updated: 2021-11-16
• Results posted: 2021-11-16

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated drug study