CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 151 enrolled
Drug / intervention
Fixed-Dose Combination of Pertuzumab and Trastuzumab SC (PH FDC SC) +2 moredrug
Likely dose
Fixed-Dose Combination of Pertuzumab and Trastuzumab SC (PH FDC SC) 600 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05275010
NCT05275010Phase 1Completed
CompareCT.gov

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

Hoffmann-La Roche·interventional·Posted Mar 11, 2022·Updated Sep 23, 2024

In Brief

A Phase 1 clinical trial evaluating Fixed-Dose Combination of Pertuzumab and Trastuzumab SC (PH FDC SC), Handheld Syringe with Hypodermic Needle, and 1 other intervention for Healthy Male Subjects. Completed, enrolled 151 participants across 5 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Male Subjects
CountriesAustralia, New Zealand
Collaborators--

Timeline

Phase 1CompletedFinished
2023202420252026
First PostedMar 11, 2022
Enrollment StartMay 30, 2022
Primary CompletionMay 14, 2023
Study CompletionOct 3, 2023
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 4.3 years ago

Interventions

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

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).

Handheld Syringe with Hypodermic Needledevice

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

On-Body Delivery Systemdevice

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