A Study in Healthy Male Subjects to Investigate the Comparability of Pharmacokinetics of the Fixed-Dose Combination of Pertuzumab and Trastuzumab Administered Subcutaneously Using a Handheld Syringe or Using the On-Body Delivery System

PHASE1CompletedINTERVENTIONAL
Enrollment

151

Participants

Timeline

Start Date

May 30, 2022

Primary Completion Date

May 14, 2023

Study Completion Date

October 3, 2023

Conditions
Healthy Male Subjects
Interventions
DRUG

Fixed-Dose Combination of Pertuzumab and Trastuzumab SC (PH FDC SC)

A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) will be administered by a healthcare professional subcutaneously (SC) into the anterior thigh, using either a handheld syringe with hypodermic needle (Arm 1) or the on-body delivery system (Arm 2).

DEVICE

Handheld Syringe with Hypodermic Needle

A single 10-mL dose of PH FDC SC will be administered as a subcutaneous (SC) injection using a handheld manual syringe.

DEVICE

On-Body Delivery System

A single 10-mL dose of PH FDC SC will be administered as a subcutaneous (SC) injection using the on-body delivery system (OBDS).

Trial Locations (5)

1010

New Zealand Clinical Research - Auckland, Auckland

4006

Q-Pharm Pty Ltd; Nucleus Network Brisbane Clinic, Herston

5000

CMAX Pty Ltd, Adelaide

6009

Linear Clinical Research Ltd, Nedlands

8011

New Zealand Clinical Research - Christchurch, Christchurch

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY