Compare the Auto-injector and Pre-filled Syringe of CT-P47 in Healthy Subjects
NCT05617183 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 268
Last updated 2023-03-27
Summary
This is a phase 1 study to compare the Pharmacokinetics and Safety of the Auto-injector and Pre-filled syringe of CT-P47 in Healthy Subjects.
Conditions
- Healthy Subjects
Interventions
- BIOLOGICAL
-
CT-P47
CT-P47, 162 mg in 0.9 mL, a single subcutaneous (SC) injection via auto-injector (AI)
- BIOLOGICAL
-
CT-P47
CT-P47, 162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS)
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
KyungSang Yu · Seoul National University College of Medicine and Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-11-15
- Primary Completion
- 2023-04-30
- Completion
- 2023-09-30
- FDA Drug
- Yes
Countries
- South Korea
Study Locations
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