A Study of Administration of Trastuzumab (Herceptin) by a Single-use Injection Device Versus a Handheld Syringe

A Randomized, Open-label, 2-arm, Parallel Group, Single Dose, Multi-center Study in Healthy Male Subjects to Investigate the Comparability of Pharmacokinetics of Trastuzumab Administered Subcutaneously as the Trastuzumab/rHuPH20 Formulation Using a Handheld Syringe or Using the Proprietary Single-use Injection Device (SID)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01344863

Enrollment

119

Registered

2011-04-29

Start date

2011-04-30

Completion date

2012-01-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

Brief summary

This randomized, open-label, parallel, 2-arm, multicenter study will compare the administration of Herceptin (trastuzumab) with a single-use injection device versus a handheld syringe in healthy male volunteers. The volunteers will receive a single dose of 600 mg Herceptin. The anticipated time of the study is 21 weeks.

Interventions

DRUGtrastuzumab [Herceptin]

600 mg subcutaneously using a single-use injection device on Day 1

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male patients, 18 to 45 years of age, inclusive * No history of hypersensitivity or allergic reactions following drug administration * No history of clinically significant or clinically relevant cardiac condition * No history of previous anticancer treatment * Body mass index (BMI) between 18-32 kg/m2, inclusive

Exclusion criteria

* Positive test result for drugs of abuse * Positive test result for hepatitis B, hepatitis C, or HIV 1 or 2 * Systolic blood pressure greater than 140 mmHG or less than 90 mmHG, or diastolic blood pressure greater than 90 mmHG or less than 50 mmHG * Clinically significant abnormal laboratory values

Design outcomes

Primary

Measure	Time frame
Area under plasma concentration curve of trastuzumab	21 days
Maximum observed plasma concentration of trastuzumab	21 days

Secondary

Measure	Time frame
Plasma concentration of trastuzumab	Day 21
Safety: Incidence of adverse events	21 weeks

Countries

New Zealand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026