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To Compare the Pharmacokinetics and Safety of CT-P17 and Humira in Healthy Subjects

NCT03970824 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2021-11-18

Study results available
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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

Conditions

  • Healthy

Interventions

BIOLOGICAL

CT-P17

40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS

BIOLOGICAL

US-licensed Humira

40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS

BIOLOGICAL

EU-approved Humira

40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS

Sponsors & Collaborators

Principal Investigators

  • Sang Joon Lee · Celltrion, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-05-31
Primary Completion
2019-11-13
Completion
2020-01-15

Countries

  • South Korea

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 NCT03970824 on ClinicalTrials.gov