A phase 1 dose-escalating study for CT-P27 on its own and in combination with Tamiflu

A Phase 1 Randomised, Open Label, Dose-Escalating Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenous CT-P27 with or without Oseltamivir in Healthy Subjects

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0001617

Enrollment

Registered

2015-09-08

Start date

2015-05-20

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 : CT-P27, 40mg/kg intravenous infusion over 90 minutes CT-P27, 60mg/kg intravenous infusion over 90 minutes CT-P27, 90mg/kg intravenous infusion over 90 minutes Ose

CT-P27 40mg/kg, 60mg/kg, 90mg/kg, respectively, as 1:1:1 ratio. Each cohort consists of CT-P27 with or without oseltamivir treatment arm as 1:1 ratio. Oseltamivir will be treated orally 10 minutes bef

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy Male & Female volunteers

Exclusion criteria

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

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