A Study to Compare the Pharmacokinetics, Safety, Tolerability and Immunogenicity of JHL1188 versus Herceptin (EU and US sourced) in Healthy Male subjects

Phase 1

Withdrawn

• Conditions: Breast Cancer; Cancer - Breast

• Registration Number: ACTRN12618001597280
• Lead Sponsor: JHL Biotech Australia Pty Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-26
• Last Update Posted: 24 November 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Male
• Target Recruitment: 159

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified