Bioequivalence double-blind, randomized, two-parallel-group phase 1 study of a humanised anti-immunoglobulin E monoclonal antibody BP001 as Lyophilized Powder Formulation Compared with the Standard Omalizumab (Xolair®) Lyophilized Powder Formulation in healthy male volunteers

Inclusion Criteria7

• Male aged 18 to 55 years, inclusive;
• Body mass index (BMI) between 18 and 30 kg/m2 inclusive, with a minimum weight of 50 kg and a maximum of 100 kg;
• Healthy as determined by pre-study medical history, physical examination (PE), vital signs, and 12-lead electrocardiogram (ECG);
• 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;
• 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;
• 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;
• 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.