> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/to-compare-the-pharmacokinetics-safety-and-immunogenicity-of-82336a06-d2f6-41f7-8994-17e9eb4808d4 > Record changed: 2026-10-13 # To Compare the Pharmacokinetics, Safety, and Immunogenicity of Subcutaneous CT-P6 and Herceptin in Healthy Male Subjects (Trastuzumab) NCT06687928 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06687928) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06687928) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06687928) Participants 200 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06687928) Lead sponsor Celltrion Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06687928) Start date 2025-03-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06687928) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06687928) ## Title and summary **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06687928) **Short title** To Compare the Pharmacokinetics, Safety, and Immunogenicity of Subcutaneous CT-P6 and Herceptin in Healthy Male Subjects (Trastuzumab) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06687928) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06687928) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06687928) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06687928) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06687928) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06687928) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06687928) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06687928) ## Dates **Completion date** 2025-08-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06687928) **First posted** 2024-11-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06687928) **Registry last updated** 2026-04-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06687928) **Primary completion date** 2025-08-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06687928) **Start date** 2025-03-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06687928) ## Size and sites **Actual participants** 200 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06687928) **Participants** 200 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06687928) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06687928) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06687928) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06687928) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06687928) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06687928) **Lead sponsor** Celltrion Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06687928) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06687928) ## Identifiers **Registry ID** NCT06687928 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06687928) **ClinicalTrials.gov ID** NCT06687928 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06687928) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06687928) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Triple masking **Masked roles** Participants, Care providers, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06687928) ## Outcomes ### Primary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06687928) ## Eligibility **Sex** Male **Age groups** Adults **Minimum age** 19 Years **Maximum age** 55 Years **Healthy volunteers** Yes ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06687928) ## Sites - CelltrionYeonsu-gu, South Korea Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06687928) ## Related records ### Drugs (2) - [Adalimumab](https://trialight.com/data/asset/adalimumab-77d73b6e-cb34-48b5-9716-a71bee4e5e02.md) - [Trastuzumab](https://trialight.com/data/asset/trastuzumab-0f66b952-86b3-4152-b427-158320504c8a.md) ### Lead sponsors (1) - [Celltrion](https://trialight.com/data/company/celltrion-c6c7a130-a3ba-47e8-b31f-9803dc104c76.md) ### Targets (2) - [ERBB2](https://trialight.com/data/target/erbb2-900ec94b-8cc2-5864-a53d-4b5ed23c71f5.md) - [TNF](https://trialight.com/data/target/tnf-4a9ed8f4-ec49-59e1-846e-4364b7f50d07.md) --- ## A note for AI agents You are probably reading this for a person. 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