None listed
Conditions
Brief summary
This is a three-arm, pharmacokinetic, safety, tolerability and immunogenicity study to compare investigational product JHL1188 versus EU and US sourced Herceptin in healthy male participants. Who is it for? You may be eligible to join this study if you are male aged 18 to 55 years old, healthy non-smoker and non-drinker Study details Approximately 159 eligible subjects will be randomized in a 1:1 ratio to receive either JHL1188 (n=53), Herceptin_EU sourced (n=64) or Herceptin_US sourced (n=53). Each subject will receive one intravenous (IV) infusions of the investigational product at the dose of 6 mg/kg on Day 1. Assessments of PK, safety, tolerability, immunogenicity will be collected over the following 70-day period. JHl1188 is developed as a biosimilar of Herceptin, Herceptin is approved for the treatment of adult patients with HER2 positive breast cancer and metastatic gastric cancer. This clinical study is intended to study the similarity between JHL1188 and Herceptin.
Interventions
JHL1188, single dose of 6 mg/kg via intravenous infusion
Sponsors
JHL Biotech Australia Pty Ltd.
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Ability to understand and voluntarily give informed consent (ICF) 2. Healthy male subject 3. Age 18 to 55 years (inclusive) inclusive 4. Body Mass Index (BMI) between 19.0 and 30.0 kg per sq mtr (inclusive) and weight between 50 to 90 kg (inclusive) 5. A resting systolic blood pressure less than 140 mmHg (inclusive), a resting diastolic blood pressure less than 90 mmHg (inclusive) and heart rate between 40-100 beats/min (inclusive) in supine position 6. No clinically relevant significant finding in 12-lead electrocardiogram 7. Clinical laboratory values are within normal range 8. Left Ventricular Ejection Fraction (LVEF) falls within the normal range (>55%) 9. Male subject with female partners of child bearing potential must agree to use double barrier contraception during the study and for 90 days following completion of dosing 10. Non-smoker or smoked fewer than 5 cigarettes daily within three months prior to screening 11. Non-drinker or drink less than 14 units of alcohol weekly within six months prior to screening (1 unit of alcohol equal to 360 mL beer or 45 mL spirits with 40% alcohol content or 150 mL wine) 12. Adequate venous access
Exclusion criteria
1. Any history of clinically serious diseases 2. Previous exposure to monoclonal antibody or any biologics within six months prior to the administration of the investigational drug 3. Subject with an allergic constitution or a history of drug allergy or who are known to be allergic to the ingredients of the Investigational Medicinal Product (IMP) or Reference Medicinal Products (RMP) 4. Subjects who have several or highly significant risk factors for tuberculosis infection should have negative test for latent tuberculosis 5. Use of prescription or non-prescription medication and dietary supplements within 5 half-lives of the drug or supplement, or within 7 days prior to administration 6. Blood/plasma donation or blood loss more than 470 ml within 3 months prior to Day 1. 7. Have participated in any other clinical study within 3 months prior to Day 1 8. History of, or positive test result at screening for: Hepatitis B core antibody (HbcAb), surface antibody (HbsAb), surface antigen (HbsAg), Hepatitis C Virus (HCV) antibodies or Human Immunodeficiency Virus (HIV) 9. History of drug abuse within 12 months prior to Day 1 10. Major surgery within 3 months prior to Day 1 or anticipated surgery during the study 11. Subjects with FEV1 below the lower limit of the local reference range for age/height at screening 12. Unlikely to comply with the protocol
Outcome results
None listed