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

Roche

Status and phase

Completed

Phase 1

Conditions

Healthy Male Subjects

Treatments

Device: Handheld Syringe with Hypodermic Needle

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

Device: On-Body Delivery System

Study type

Interventional

Funder types

Industry

Identifiers

NCT05275010

WP42873

Details and patient eligibility

About

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.

Enrollment

151 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male subjects age 18-45 years at time of signing Informed Consent Form
Ability to comply with the study protocol
Agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, during the treatment period and for 7 months after the dose of PH FDC SC
A body mass index (BMI) between 18 and 32 kilograms per metre squared (kg/m2), inclusive
Intact normal skin without potentially obscuring tattoos, pigmentation, or lesions in the area for intended injection on the thighs
Baseline LVEF≥55% measured by echocardiogram (ECHO)
No history of hypersensitivity or confirmed, clinically significant and clinically relevant allergic reactions, either spontaneously or following any drug administration
No history of any clinically significant and clinically relevant cardiac condition
No history of previous anticancer treatments including pertuzumab, trastuzumab, anthracyclines, or any cardiotoxic drugs
No apparent family history of clinically significant and clinically relevant hypersensitivity, allergy, and severe cardiac diseases
No contraindications from detailed medical and surgical history and physical examinations
No previous enrollment in this study protocol and no concurrent enrollment in any other study protocol

Exclusion criteria

Positive urine test for drugs of abuse as per local standard (for alcohol abuse, positive breath test is also acceptable)
Positive test result for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) 1 or 2, showing: History of exposure to HBV, HCV, or HIV; or Active viral hepatitis infection (HBV or HCV) or HIV infection
Systolic blood pressure ≥140 millimetres of mercury (mmHg) or <90 mmHg, or diastolic blood pressure >90 mmHg or <50 mmHg
Use of prohibited medications including non-prescription medications, nutraceuticals, nutritional supplements or any herbal remedies taken within 10 days or 5 times the elimination half-life (whichever is longer) prior to randomization into the study
Concomitant subcutaneous, intravenous, or any parenteral drugs within 90 days prior to screening
Participation in an investigational drug or device study within 90 days or five times the elimination half-life (whichever is longer) prior to screening
Donation of blood over 500 millilitres (mL) within 3 months prior to enrollment
Known severe hypersensitivity to plaster, medical adhesive tapes, or bandages
Known allergy to murine proteins, hyaluronidase, bee, or vespid venom, or any other ingredient in the formulation of rHuPH20 (Hylenex® recombinant [hyaluronidase human injection]) or any other ingredients and excipients in the formulation of PH FDC SC
Clinically significant abnormalities in laboratory test results (including hepatic and renal panels, CBC, chemistry panel, and urinalysis)
Clinically relevant electrocardiogram abnormalities at screening or Day -1
History of any cardiac condition
Lower extremity edema or pathology (e.g., cellulitis, lymphatic disorder or prior surgery, pre-existing pain syndrome, previous lymph node dissection etc.) that could interfere with any protocol-specified outcome assessment
Any history of clinically significant and clinically relevant allergies, oncologic, psychiatric, gastrointestinal, renal, hepatic, cardiovascular or pulmonary disease
Concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in this study
Any clinically relevant history of systemic disease (e.g., malignancy, diabetes mellitus, gastrointestinal, renal, hepatic, cardiovascular, rheumatological, or pulmonary disease)
History of breast cancer or treatment for breast cancer
Current chronic daily treatment (continuous for >3 months) with corticosteroids (dose ≥10 mg/day methylprednisolone), excluding inhaled corticosteroids
Receipt of intravenous antibiotics for infection within 7 days prior to enrollment into the study

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

151 participants in 2 patient groups

Arm 1: PH FDC SC Using a Handheld Syringe

Active Comparator group

Description:

A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) will be administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using a handheld syringe with hypodermic needle.

Treatment:

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

Device: Handheld Syringe with Hypodermic Needle

Arm 2: PH FDC SC Using the OBDS

Experimental group

Description:

Treatment:

Device: On-Body Delivery System

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

Trial documents