At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 312 enrolled
Drug / intervention
CT-P17 +2 morebiological
Likely dose
CT-P17 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1, Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of CT-P17 and Humira (US-licensed Humira and EU-approved Humira) in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating CT-P17, US-licensed Humira, and 1 other intervention for Healthy. Completed, enrolled 312 participants across 9 sites.
Detailed Summary
This is a Phase 1, Randomized, Double-blind, Three-arm, Parallel group, Single-dose Study to Compare the Pharmacokinetics and Safety of CT-P17 and Humira (US licensed Humira and EU-approved Humira) in Healthy Subjects
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesSouth Korea
Collaborators--
Timeline
Phase 1CompletedFinished
2020202120222023202420252026
Enrollment StartMay 2019
First PostedJun 2019
Primary CompletionNov 2019
Study CompletionJan 2020
TodayJul 2026
First PostedJun 3, 2019
Enrollment StartMay 31, 2019
Primary CompletionNov 13, 2019
Study CompletionJan 15, 2020
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 7.1 years ago
Interventions
CT-P17biological
40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS
US-licensed Humirabiological
40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS
EU-approved Humirabiological
40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS