NCT04295356

To Compare the Pharmacokinetics and Safety of the Auto-injector and Pre-filled Syringe of CT-P17

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Celltrion · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	CT-P17	subjects will receive a single dose (40 mg) of CT-P17 via AI on Day 1 followed by 10 weeks
BIOLOGICAL	CT-P17	subjects will receive a single dose (40 mg) of CT-P17 via PFS on Day 1 followed by 10 weeks

Timeline

• Start date: 2019-06-21
• Primary completion: 2019-11-15
• Completion: 2019-11-15
• First posted: 2020-03-04
• Last updated: 2021-01-19
• Results posted: 2020-12-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study