A Pharmacokinetic Study Comparing EG12014 and Herceptin (Trastuzumab) in Healthy Male Volunteers

NCT03180242 | Completed Phase 1

• 1 other identifier: EGC001
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this trial is to assess the pharmacokinetic similarity of EG12014 (Test IMP) compared to reference products sourced from the European Union (Reference IMP 1: Herceptin® 150 mg powder for concentrate for solution for infusion) and the United States (Reference IMP 2: Herceptin® 440 mg powder for concentrate for solution for infusion) after intravenous infusion over 90 minutes of a single dose of 6 mg/kg trastuzumab in 3 parallel groups of healthy male subjects.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Area under the concentration/time curve, from time 0 h extrapolated to infinity (AUC(0-∞))

  70 days

Secondary Outcomes (10)

• Peak Plasma Concentration (Cmax)

  70 days

• Area under the concentration/time curve, calculated by the trapezoidal rule from time 0 h to last observed concentration at time t (AUC(0-t))

  70 days

• Residual area in percent (AUCres)

  70 days

• Serum concentration half-life (t½)

  70 days

• Adverse events

  70 days

Study Arms (3)

EG12014

EXPERIMENTAL

EG12014

Biological: EG12014

EU-sourced Herceptin

ACTIVE COMPARATOR

EU-sourced Herceptin

Biological: EU-sourced Herceptin

US-sourced Herceptin

ACTIVE COMPARATOR

US-sourced Herceptin

Biological: US-sourced Herceptin

Interventions

EG12014 BIOLOGICAL

EG12014, single-dose IV infusion over 90 min at 6 mg/kg

EG12014

EU-sourced Herceptin BIOLOGICAL

EU-sourced Herceptin, single-dose IV infusion over 90 min at 6 mg/kg

EU-sourced Herceptin

US-sourced Herceptin BIOLOGICAL

US-sourced Herceptin, single-dose IV infusion over 90 min at 6 mg/kg

US-sourced Herceptin

Eligibility Criteria

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

You may qualify if:

• male Caucasian subject
• age between 18 and 55 years (inclusive)
• physically and mentally healthy as judged by means of medical and standard laboratory examinations
• non-smokers or ex-smokers (stopped at least 6 months ago) with a smoking history of ≤5 pack-year equivalents (1 pack-year equivalent is equal to smoking 1 pack per day for 1 year ) and non-users of other nicotine containing products, confirmed by urine cotinine test
• BMI within the range (including the borders) of 18.5 to 30.0 kg/m2 and body weight not more than 105.0 kg
• Informed consent given in written form according to Section 5.4 of the protocol.

You may not qualify if:

• participation in another clinical trial at same time or within the preceding 3 months from the screening examination (calculated from the date of the final examination of the previous study)
• randomization into the present trial more than once
• blood donation or blood loss including plasmapheresis of \>500 ml in the last 3 months before day 0 of the study
• history of drug abuse or use of illegal drugs: use of soft drugs, e.g. marihuana within 6 months of screening or hard drugs, e.g. cocaine, amphetamines, opioids, phencyclidine within 1 year of screening
• alcohol abuse, i.e. regular use of more than 2 units of alcohol per day or 10 units per week or a history of alcoholism (one unit of alcohol equals 250 ml beer, 125 ml wine or 25 ml spirits) or recovered alcoholics
• regular consumption of beverages or food containing methylxanthines (e.g. coffee, tea, cola, caffeine containing sodas, chocolate) equivalent to more than 500 mg methylxanthines per day
• positive drug screening and/or positive alcohol test at entry screening or on hospitalization day 0
• history of allergic diathesis or any clinically significant allergic disease (e.g. asthma or bronchial hyperreactivity, or allergic reactions to insect bites)
• any history of drug hypersensitivity (especially to the active and inactive ingredients of the trastuzumab preparation, or other monoclonal antibody or protein drugs) or intolerance to any sugar (e.g. fructose, glucose, or lactose)
• presence or a history of clinically significant cardiovascular, renal, hepatic, pulmonary, metabolic, endocrine, hematological, gastrointestinal, neurological, psychiatric or other diseases
• clinically significant illness within 4 weeks before day 0 of the study and during the study
• major surgery of the gastrointestinal tract except for appendectomy
• any chronic disease which might interfere with resorption, distribution, metabolism or excretion of the drug
• positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies
• administration of depot injectable solutions or medications with a half-life \> 1 week (including study medications) within 6 months from day 0 of the study

Sponsors & Collaborators

• EirGenix, Inc.: lead

Study Design

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

Study Record Dates

• First Submitted: May 17, 2017
• First Posted: June 8, 2017
• Study Start: March 22, 2016
• Primary Completion: August 22, 2016
• Study Completion: August 22, 2016
• Last Updated: June 8, 2017

Record last verified: 2017-06