NCT02665637 is a Phase 1 clinical trial of Trastuzumab in Healthy Volunteers, sponsored by Celltrion.

Who is sponsoring NCT02665637?

NCT02665637 is sponsored by Celltrion.

What drugs are being tested in NCT02665637?

Interventions in NCT02665637: Trastuzumab.

What condition does NCT02665637 study?

NCT02665637 studies Healthy Volunteers.

Is NCT02665637 still recruiting?

NCT02665637 is currently completed. Last updated 24 August 2016.

Last reviewed 2016-08-24 · How we verify

NCT02665637

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Randomized, Double-blind, Two-arm, Parallel-group, Single Dose Study to Compare the Pharmacokinetics, Safety and Immunogenicity of Two Formulations of Trastuzumab (CT-P6 and US-licensed Herceptin) in Healthy Subjects

Completed Phase 1 Last updated 24 August 2016

What this trial tests

Phase 1 trial testing Trastuzumab in Healthy Volunteers in 70 participants. Completed in 1 April 2016.

Timeline

1 December 2015

Primary endpoint
1 April 2016

1 April 2016

Quick facts

Lead sponsor	Celltrion
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Enrollment	70
Start date	1 December 2015
Primary completion	1 April 2016
Estimated completion	1 April 2016
Sites	1 location across United States

Drugs / interventions tested

Trastuzumab (trastuzumab) — full drug profile →

Conditions studied

Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Celltrion — full company profile →

Who can join

Adults 18 to 55, male only, with Healthy Volunteers. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Pharmacokinetics will be assessed by AUC
Time frame: up to week 10
Pharmacokinetics will be assessed by AUC.

Sponsor's own description

This is a double-blind, two-arm, parallel-group, single-dose study.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

A randomised trial comparing the pharmacokinetics and safety of the biosimilar CT-P6 with reference trastuzumab.
Esteva FJ, Stebbing J, Wood-Horrall RN, Winkle PJ, et al · · 2018 · cited 26× · PMID 29330636 · DOI 10.1007/s00280-017-3510-7

Verify or expand the search:

Other trials of Trastuzumab

Trials testing the same drug.

NCT07413939 — RO7771950 Versus Tucatinib in Combination With Trastuzumab and Capecitabine in People With Locally Advanced or Metastati · Phase 2, PHASE3 · not yet recruiting
NCT07441460 — A Phase III Study of KN026 in Combination With HB1801 as Adjuvant Therapy for Resectable HER2-Positive Breast Cancer · Phase 3 · recruiting
NCT07402473 — EUREKA Study:Phase 2 Study to Optimize Neoadjuvant Therapy in HER2-positive Early-stage Breast Cancer · Phase 2 · not yet recruiting
NCT07377643 — IBI354 With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer · Phase 3 · recruiting
NCT07366840 — RC48 Combined With Chemotherapy in HER2-Positive Advanced Breast Cancer Patients With Prior TOP1i-ADC Failure · Phase 2, PHASE3 · not yet recruiting

Other recruiting trials for Healthy Volunteers

Currently open trials in the same condition.

NCT07504003 — Influence of Training Session Duration on Improvements in Physiological Resilience to Exercise · NA · recruiting
NCT07446400 — A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuva · Phase 1 · recruiting
NCT07495813 — A Study to See How RO7763505 Works and How Safe it is When Given to Healthy People and People With Stable Heart Disease · Phase 1 · recruiting
NCT07499050 — A Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity · Phase 1 · recruiting
NCT07342114 — A Dose-Escalation Study of RO7875913 in Healthy Participants · Phase 1 · recruiting

Other Celltrion trials

Trials by the same sponsor.

NCT07533539 — Phase I Study to Evaluate the Pharmacokinetics and Safety After Co-administration of L03RD1 and L03RD2 or Administration · Phase 1 · recruiting
NCT07200986 — Study to Compare Pharmacokinetics and Safety of CT-P52 and US-licensed Taltz in Healthy Subjects · Phase 1 · active not recruiting
NCT07128654 — A Bioequivalence Study of CT-L02 Compared to Co-administration (CTL0201 and CTL0202) in Healthy Volunteers · Phase 1 · completed
NCT07158346 — Phase I Study to Evaluate the Pharmacokinetics and Safety After Co-administration of L03RD1 and L03RD2 or Administration · Phase 1 · completed
NCT06952478 — A Study to Compare Pharmacokinetics, Efficacy and Safety of Subcutaneous CT-P44 and Darzalex Faspro in Combination With · Phase 3 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02665637 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Celltrion
Last refreshed: 24 August 2016

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02665637.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing