NCT05275010

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

A Randomized, Open-Label, 2-Arm, Parallel Group, Single Dose, Multi-Centre 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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, open-label, 2-arm, parallel-group, single-dose, multi-center study in healthy male subjects to investigate the comparability of the pharmacokinetics of the fixed-dose combination of pertuzumab and trastuzumab administered subcutaneously using the proprietary on-body delivery system or a handheld syringe with hypodermic needle.

Conditions

• Healthy Male Subjects

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2022-05-30
• Primary completion: 2023-05-14
• Completion: 2023-10-03
• First posted: 2022-03-11
• Last updated: 2024-09-23
• Results posted: 2024-09-23

Locations

5 sites across 2 countries: Australia, New Zealand

Regulatory

• FDA-regulated drug study