At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1, Randomized, Open-label, Two-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of the Auto-injector and Pre-filled Syringe of CT-P17 in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating CT-P17 for Healthy. Completed, enrolled 180 participants across 1 site.
Detailed Summary
This study was phase 1, randomized, open-label, two-arm, parallel group, single-dose study, which was designed to compare the pharmacokinetics (PK) and safety of CT-P17 SC administration via AI and PFS in healthy subjects. Approximately 180 subjects were enraollend and randomly assigned to one of the two treatment arms in a 1:1 ratio. In each treatment arm, all subjects received a single dose (40 mg) of CT-P17 via either AI or PFS on Day 1 followed by 10 weeks during which PK, safety, and immunogenicity measurements were made. The randomization to treatment assignment was stratified by body weight (≥80 kg vs. \<80 kg) as measured on baseline (Day -1), gender (male vs. female) and study center.
Study Details
Timeline
Interventions
subjects will receive a single dose (40 mg) of CT-P17 via AI on Day 1 followed by 10 weeks
subjects will receive a single dose (40 mg) of CT-P17 via PFS on Day 1 followed by 10 weeks