A Pharmacokinetic Study Comparing EG1206A and Perjeta (Pertzumab) in Healthy Male Volunteers

NCT05471648 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: EGC1012021-006769-40
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is a single-center, single-dose, double-blind, parallel-group, randomized, 3-arm PK trial in healthy male volunteers comparing a biosimilar pertuzumab (EG1206A) to a single intravenous (i.v.) infusion to both European Union (EU) and United States of America (US) reference products.

Conditions

Breast Cancer

Keywords

HER2 positive; early stage breast cancer; metastatic breast cancer; combination therapy; inhibiting MAP Kinase; P13K/Akt

Outcome Measures

Primary Outcomes (1)

• AUC0-inf of pertuzumab

  Area under the plasma concentration-time curve, from time 0 h extrapolated to infinity

  Pre-dose to day 91, 21 timepoints

Secondary Outcomes (8)

• Cmax

  Pre-dose to day 91, 21 timepoints

• tmax

  Pre-dose to day 91, 21 timepoints

• t1/2

  Pre-dose to day 91, 21 timepoints

• Drug clearance (CL)

  Pre-dose to day 91, 21 timepoints

• Volume of distribution (Vd)

  Pre-dose to day 91, 21 timepoints

Other Outcomes (5)

• Local tolerability at infusion site

  Day 1 to day 15, 14 timepoints

• Vital sign - blood pressure

  Day 1 to day 91, 8 timepoints

• Vital sign - pulse rate

  Day 1 to day 91, 8 timepoints

Study Arms (3)

420 mg EirGenix Pertuzumab

EXPERIMENTAL

EirGenix Pertuzumab given intravenous with an infusion bag as a single dose of 420 mg over 60min.

Drug: 420 mg EG1206A EirGenix Pertuzumab in 14 mL Injection

420 mg Pertuzumab Perjeta EU Origin

ACTIVE COMPARATOR

EU Pertuzumab given intravenous with an infusion bag as a single dose of 420 mg over 60min.

Drug: Perjeta (EU origin) 420 mg in 14 mL Injection

420 mg Pertuzumab Perjeta US Origin

ACTIVE COMPARATOR

US Pertuzumab given intravenous with an infusion bag as a single dose of 420 mg over 60min.

Drug: Perjeta (US origin) 420 mg in 14 mL Injection

Interventions

420 mg EG1206A EirGenix Pertuzumab in 14 mL Injection DRUG

Healthy volunteers receive pertuzumab (EG1206A, 420 mg, single dose)

Also known as: Pertuzumab

420 mg EirGenix Pertuzumab

Perjeta (EU origin) 420 mg in 14 mL Injection DRUG

Healthy volunteers receive pertuzumab (Perjeta (EU origin) 420 mg, single dose)

Also known as: Pertuzumab

420 mg Pertuzumab Perjeta EU Origin

Perjeta (US origin) 420 mg in 14 mL Injection DRUG

Healthy volunteers receive pertuzumab (Perjeta (US origin), 420 mg, single dose)

Also known as: Pertuzumab

420 mg Pertuzumab Perjeta US Origin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• aged 18 to 55 years
• overtly healthy as determined by medical evaluation
• Body weight of at least 50 kg and not higher than 105 kg at screening
• BMI above/equal to 18.0 and below/equal to 30.0 kg/m2 at screening
• Male
• Agrees to the following during the treatment period and until 3 months after administration:
• Be and remain abstinent from heterosexual intercourse OR agree to use a male condom and female partners of childbearing potential must use an additional highly effective contraceptive method
• Abstain from donating sperm.
• Signed informed consent
• Valid COVID-19 immunization status as per current regulations

You may not qualify if:

• History or evidence of any clinically relevant disease, as judged by the investigator
• Any medical disorder, condition, or history of such that would impair the participant's ability to participate or complete this trial in the opinion of the investigator
• Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination, and effects of the IMP will not be normal
• Known or suspected hypersensitivity to the IMPs (active substances, or excipients of the preparations)
• Known severe allergies e.g., allergies to more than 3 allergens
• Relevant diseases within the last 4 weeks before IMP administration
• Febrile illness within 2 weeks before IMP administration.
• History of known or suspected malignant tumors
• Known or suspected disorder of the liver
• Use of systemic/topical medicines/substances which oppose the trial objectives, or which might influence them within 4 weeks before IMP administration
• Regular use of therapeutic or recreational drugs or supplements
• Use of any herbal products or St. John's wort from 4 weeks before IMP administration
• Prior treatment with pertuzumab
• Smoking
• History of alcohol or drug abuse

Sponsors & Collaborators

• EirGenix, Inc.: lead
• Sacura GmbH: collaborator

Study Sites (1)

CRS Clinical Research Services Berlin GmbH

Berlin, 13353, Germany

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Injections; pertuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Matthias Berse, Dr. med.

  CRS Clinical Research Services Berlin GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 1, Double-Blind, Randomized, Parallel-Group, Single-Dose, 3-Arm, Comparative Pharmacokinetic Trial of EirGenix' Pertuzumab and Perjeta® (Pertuzumab) sourced from US and EU Administered to Healthy Male Volunteers

Study Record Dates

• First Submitted: July 8, 2022
• First Posted: July 25, 2022
• Study Start: May 16, 2022
• Primary Completion: January 24, 2023
• Study Completion: January 24, 2023
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)