Comparing a new version of trastuzumab with Herceptin in healthy men
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
This study is testing a new version of a breast cancer drug called CT-P6 in healthy men to see how it works in the body compared to the original drug, Herceptin.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 19 Years to 55 Years |
| Sex | Male |
| Sponsor | Celltrion Industry-sponsored |
| Drugs / interventions | trastuzumab |
| Locations | 1 site (Yeonsu-gu, Incheon) |
| Trial ID | NCT06687928 on ClinicalTrials.gov |
What this trial studies
This study is a randomized, double-blind, two-arm, parallel-group, single-dose Phase 1 trial designed to compare the pharmacokinetics, safety, and immunogenicity of CT-P6, a proposed biosimilar to Herceptin, in healthy male subjects. Participants will receive either CT-P6 or the EU-approved Herceptin SC to evaluate how the body processes the drug, its safety profile, and the immune response it generates. The study aims to ensure that CT-P6 has a similar quality profile to the reference product while assessing its potential as a treatment option.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy male subjects aged 19 to 55, with a body weight between 60 and 90 kg and a BMI between 18.0 and 29.9 kg/m2.
Not a fit: Patients who are not healthy or fall outside the specified age and weight criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accessible and potentially cost-effective alternative to Herceptin for patients requiring trastuzumab therapy.
How similar studies have performed: Other studies have shown success with similar biosimilar approaches, indicating a promising avenue for further development.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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. Exclusion Criteria: * 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
Where this trial is running
Yeonsu-gu, Incheon
- Celltrion — Yeonsu-gu, Incheon, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: HeeJoo Ko
- Email: heejoo.ko@celltrion.com
- Phone: +82-32-850-5807
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.