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

NCT06687928 | Completed Phase 1

• 1 other identifier: CT-P6 1.6
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Demonstrate PK similarity

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

  Up to Day 64

• Demonstrate PK similarity

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

  Up to Day 64

Study Arms (2)

Subcutaneous CT-P6

EXPERIMENTAL

Subcutaneous CT-P6 (CT-P6 SC): 600 mg/5 mL

Biological: CT-P6 SC

Subcutaneous EU-approved Herceptin

ACTIVE COMPARATOR

Subcutaneous Herceptin (EU-approved Herceptin SC): 600 mg/5 mL

Biological: EU-Approved Herceptin SC

Interventions

CT-P6 SC BIOLOGICAL

A single fixed dose (600 mg) of CT-P6 subcutaneous

Subcutaneous CT-P6

EU-Approved Herceptin SC BIOLOGICAL

A single fixed dose (600 mg) of EU-approved Herceptin subcutaneous

Subcutaneous EU-approved Herceptin

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subject between 19 and 55 years of age
• Body weight between 60 and 90 kg, BMI between 18.0 and 29.9 kg/m2
• 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.
• 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:
• Condom with or without spermicide
• True abstinence, when this is in line with the preferred and usual lifestyle of the subject
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Celltrion: lead

Study Sites (1)

Celltrion

Yeonsu-gu, Incheon, 22006, South Korea

Location

Study Officials

• Minji Ma

  Celltrion, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A Randomized, Double-blind, Two-arm, Parallel-group, Single-dose, Phase 1 Study

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 14, 2024
• Study Start: March 26, 2025
• Primary Completion: August 5, 2025
• Study Completion: August 5, 2025
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

KR (1)