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
Overview
- Phase
- Phase 1
- Intervention
- CT-P63
- Conditions
- SARS-CoV-2 Infection
- Sponsor
- Celltrion
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- To evaluate safety and tolerability of single ascending dose of CT-P63:
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
CT-P63
Single Ascending Dose
Intervention: CT-P63
Placebo
Single Ascending Dose
Intervention: Placebo
Outcomes
Primary Outcomes
To evaluate safety and tolerability of single ascending dose of CT-P63:
Time Frame: 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 Outcomes
- To evaluate the Pharmacokinetic(PK) of CT-P63(Up to 90 Days)
- To evaluate immunogenicity of single ascending dose of CT-P63:(Up to 90 Days)