Phase I Dose escalating study for CT-P27

A Phase I, Randomised, Double-Blind, Placebo-Controlled, Dose-Escalating Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenous CT-P27 in Healthy Subjects.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0001179

Enrollment

Registered

2014-07-23

Start date

2013-07-05

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Biological/Vaccine, Non-Stem Cell : Test Formulation, Dose and Regimen: Arm 1: CT-P27 2mg/kg, intravenous infusion over 90 min (± 15 min) Arm 2: CT-P27 5mg/kg, intravenous infusion over 90 min (± 15

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Subject is healthy male or female, and between 18 and 55 years old (both inclusive). 2. Subject's body mass index (BMI) is of =30.0 kg/m2 and weight is of =50.0 kg.

Exclusion criteria

Exclusion criteria: 1. Subject has a medical condition of disease including endocrine, cardiovascular, infection, cancer, or renal, neurological, hemotologic disease. 2. History or presence of regular alcohol consumption 3. Subject in pregnancy or breastfeeding 4. Veins unsuitable for infusion and/or repeat venipuncture 5. Vulnerable subjects

Design outcomes

Primary

Measure	Time frame
Safety and Tolerability of CT-P27	—

Secondary

Measure	Time frame
Pharmacokinetics of CT-P27 components (CT-P22 and CT-P23);Safety and Tolerability of CT-P27	—

Countries

Korea, Republic of

Contacts

Public ContactSoonYoung Lee

Celltrion

SoonYoung.Lee@celltrion.com+82-32-850-6595

Outcome results