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

NCT04295356 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2021-01-19

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • Sung Hyun Kim, Dr · Celltrion

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-21
Primary Completion
2019-11-15
Completion
2019-11-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04295356 on ClinicalTrials.gov