To Compare the Pharmacokinetics, Safety, and Immunogenicity of Subcutaneous CT-P6 and Herceptin in Healthy Male Subjects (Trastuzumab)

Phase
Recruitment status
Participants
Lead sponsor
Start date
Number of sites

Summary
A Randomized, Double-blind, Two-arm, Parallel-group, Single-dose, Phase 1 Study to Compare the Pharmacokinetics, Safety, and Immunogenicity of Subcutaneous CT-P6 and Herceptin in Healthy Male Subjects
Short title
To Compare the Pharmacokinetics, Safety, and Immunogenicity of Subcutaneous CT-P6 and Herceptin in Healthy Male Subjects (Trastuzumab)
Official title
A Randomized, Double-blind, Two-arm, Parallel-group, Single-dose, Phase 1 Study to Compare the Pharmacokinetics, Safety, and Immunogenicity of Subcutaneous CT-P6 and Herceptin in Healthy Male Subjects

Control arm
Active comparator
Registry reports results
Listing at source
Recruitment status
Phase
Study type
Interventional

Completion date
First posted
Registry last updated
Primary completion date
Start date

Actual participants
Participants
Participant count basis
Protocol amendments
Number of sites

Data monitoring committee
Registry sponsor category
Lead sponsor
Source registry
ClinicalTrials.gov

Registry ID
ClinicalTrials.gov ID
Registry record
Open registry record

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Triple masking
Masked roles
Participants, Care providers, Investigators
Sources for study design

  1. Demonstrate PK similarity

    Timeframe: Up to Day 64

    maximum serum concentration (Cmax) of CT-P6 SC to EU-approved Herceptin SC

  2. Demonstrate PK similarity

    Timeframe: Up to Day 64

    area under the concentration-time curve from time zero to infinity (AUC0-inf) of CT-P6 SC to EU-approved Herceptin SC

Sources for outcomes

Sex
Male
Age groups
Adults
Minimum age
19 Years
Maximum age
55 Years
Healthy volunteers
Yes

  1. Healthy male subject between 19 and 55 years of age

  2. Body weight between 60 and 90 kg, BMI between 18.0 and 29.9 kg/m2

  3. Subject is informed and able to understand the full nature and purpose of the study, including possible risks and side effects, and is given ample time and opportunity to read and understand this information. The subject has the ability and agrees to cooperate with the investigator and must sign and date the written informed consent prior to performing any of the Screening procedures.

  4. Subject who is sexually active with a woman of childbearing potential must agree to use a highly effective and medically acceptable methods of contraception consistent with local regulations during the course of the study and for 7 months after administration of the study drug (Day 1). Examples include the following:

    1. Condom with or without spermicide
    2. True abstinence, when this is in line with the preferred and usual lifestyle of the subject
    3. Or, a female partner with hormonal contraceptive or barrier method

Subject who has been surgically sterilized for less than 24 weeks prior to the date of informed consent and his female partner of childbearing potential must agree to use any medically acceptable methods of contraception.

  • A medical history and/or condition that is considered significant
  • Clinically significant allergic reactions, hypersensitivity
  • History or congestive heart failure, NYHA class ≥ class II
  • Current infection of hepatitis B virus, hepatitis C virus, human immunodeficiency virus, or syphilis
  • History or current of malignancy
  • Previous exposure to trastuzumab or any drugs including Human epidermal growth factor receptor 2 (HER2) targeted monoclonal antibodies
  • History or current use of recombinant human hyaluronidase (rHuPH20) or drugs including rHuPH20
Sources for eligibility

  • CelltrionYeonsu-gu, South Korea
Sources for sites

Related records

Drugs (2)

Lead sponsors (1)

Targets (2)