None listed
Conditions
Brief summary
This is a double-blind pharmacokinetic study designed to assess bioequivalence between a test, BP001, and reference formulation, Xolair®, of 150 mg omalizumab. The study will consist of 84 healthy male participants, each receiving a single 150 mg subcutaneous dose of BP001 or Xolair® in a randomized parallel-group design.
Interventions
Study intervention is BP001 (Omalizumab), a biosimilar of Xolair® (Omalizumab).
150mg of BP001 will be administered via subcutaneous injection, once only in the upper arm, on Day 1 of the study.
n=84 subjects are to be enrolled in the study, across 2 arms.
Arm 1 (test formulation) will consist of n=42 subjects, who will be dosed once with BP001.
Arm 2 (reference formulation) will consist of n=42 subjects, who will be dosed with the comparator, Xolair®.
Sponsors
Biosana Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male aged 18 to 55 years, inclusive; 2. Body mass index (BMI) between 18 and 30 kg/m2 inclusive, with a minimum weight of 50 kg and a maximum of 100 kg; 3. Healthy as determined by pre-study medical history, physical examination (PE), vital signs, and 12-lead electrocardiogram (ECG); 4. Negative tests for Hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV) and human immunodeficiency virus HIV-1and HIV-2 antibody at screening; 5. Normal blood chemistry values, or any abnormalities should be not clinically significant, as determined by the investigator at screening and Day -1. Serum IgE < 100 U/ml will be assessed for eligibility at screening only. Lab tests may be repeated once at the discretion of the investigator; 6. Negative screen for alcohol and drugs of abuse at screening and admission; Drugs of abuse may be repeated at the discretion of the investigator to account for a false positive ie. where a participant has consumed poppy seeds; 7. Must be practicing a highly effective method of birth control with female partners of childbearing potential from screening throughout the study and for at least 90 days after the investigational drug administration. Highly effective birth control methods include vasectomy, abstinence or condom use in combination with partner’s use of highly effective contraception (i.e. hormonal contraceptives including oral, patch, vaginal ring, implant or injection, intra uterine device (IUD), or documented evidence of surgical sterilization at least 6 months prior to screening visit (i.e. tubal ligation or hysterectomy). Subjects with same sex partners (abstinence from penile-vaginal intercourse) are eligible when this is their preferred and usual lifestyle.
Exclusion criteria
1. Unwillingness or inability to follow the procedures outlined in the protocol; 2. Positive drug screen at Screening or Day -1; 3. Have a history of drug abuse; 4. History of alcohol abuse; 5. Regular smokers within 2 months prior to screening. Social smokers (Less than or equal to 10 cigarettes/week) may be included if they agree to abstain for the duration of the trial; 6. Participation in studies with monoclonal antibody therapy within 6 months of Screening or previous exposure to omalizumab; 7. Participated in any other investigational clinical study in which administration of an investigational study drug occurred within 30 days or 5 half-lives of the product (whichever is the longest) prior to Screening; 8. History of clinical relevant history of allergy related diseases including hay fever, urticaria, allergic asthma, allergic rhinitis; Mild allergic conditions may be included at the discretion of the Investigator; 9. History of sensitivity to any component of the investigational product formulation or a history of drug or other allergy that, in the opinion of the investigator, contraindicates their participation; 10. Any concurrent disease, physical and/or mental condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results; 11. Subjects with surgical or medical conditions that may significantly alter the absorption form subcutaneous tissue, distribution, metabolism or excretion of omalizumab.
Outcome results
None listed