To Evaluate the Safety, Tolerability and Pharmacokinetics of CT-P63 in Healthy Subjects
- Registration Number
- NCT05017168
- Lead Sponsor
- Celltrion
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description CT-P63 CT-P63 Single Ascending Dose Placebo Placebo Single Ascending Dose
- Primary Outcome Measures
Name Time Method To evaluate safety and tolerability of single ascending dose of CT-P63: Up to 14 Days 1. Proportion of patients with Treatment Emergent Adverse Events (TEAEs) by CTCAE v5.0
2. Proportion of patients with Treatment Emergent Serious Adverse Events (TESAEs) by CTCAE v5.0
3. Proportion of patients with TEAEs of special interest (IRR including hypersensitivity/anaphylactic reaction) by CTCAE v5.0
- Secondary Outcome Measures
Name Time Method To evaluate the Pharmacokinetic(PK) of CT-P63 Up to 90 Days PK parameter: Volume of distribution at steady state (Vss)
To evaluate immunogenicity of single ascending dose of CT-P63: Up to 90 Days Incidence of ADA and NAbs to CT-P63 (positive or negative)
Trial Locations
- Locations (1)
Biokinetica S.A
🇵🇱Józefów, Poland