Clinical trial NCT04361812: Comparison of Pharmacokinetics and Safety of HS632 and Xolair® With a Single Injection
Official title: A Multicenter, Randomized, Double-blind, Parallel Controlled，Single-dose Phase I Study Comparing the Pharmacokinetic and Safety Similarities of Recombinant Anti IgE Humanized Monoclonal Antibody (HS632) With Omalizumab a in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Similarity of Pharmacokinetics and Safety
Lead sponsor: BioRay Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-04-24
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the bioequivalence of HS632 and Omalizumab (Xolair®) in a single subcutaneous administration in healthy subjects.

Detailed description: This is a multicenter, randomized, double-blind, parallel controlled，single-dose phase I study to compare the pharmacokinetic and safety similarities of recombinant anti IgE humanized monoclonal antibody (HS632) With omalizumab a in Chinese healthy subjects.

Eligibility criteria: Inclusion Criteria:

* 1.Signing the informed consent and being able to complete the test according to the plan;
* 2.Age ≥ 18 and ≤ 40 (subject to the date of signing the informed consent), male;
* 3.The body mass index (BMI) is between 20and6 kg / m2 (including 20 kg / m2 and 26 kg / m2), and the body weight is between 50-75 kg (including 50 kg and 75 kg);
* 4.The subject (including the partner) has no plan of pregnancy from the date of signing informed consent to 6 months after the administration of the experimental drug and is willing to use effective contraceptive methods, such as abstinence, oral contraceptives, iUDs or double barrier methods (e.g., condom plus diaphragm)

Exclusion Criteria:

* 1.Patients with mental, respiratory, cardiovascular, digestive, urinary, reproductive, skeletal and motor, blood, endocrine, nervous and other system diseases, or patients with any previous immune diseases;
* 2.Patients with severe bleeding factors affecting venous blood collection
* 3.Skin diseases or other diseases affecting subcutaneous injection;
* 4. Patients with upper respiratory tract infection or other acute infection in the 2 weeks prior to screening;
* 5.Patients with history of malignant tumor;
* 6.Those who have undergone surgery within two months before signing the informed consent;
* 7.Drinking more than 14 units of alcohol per week (14 bottles of 360 ml beer or 630ml of 40% spirits or 2100ml of wine) within 6 months before screening, or those with positive results of alcohol breath test;
* 8.Those who have used soft drugs (e.g., marijuana) within 3 months prior to signing the informed consent or hard drugs (e.g., cocaine, phencyclidine, etc.) within 1 year prior to the trial； those who have positive drug abuse test results (morphine, methamphetamine, ketamine, MDMA, tetrahydrocannabinolic acid, cocaine);
* 9. Those who are addicted to smoking or smoke more than 5 cigarettes per day on average in the 3 months before signing the informed consent; or those who have positive nicotine results;
* 10.Those who have a history of drug or food allergy, or who have special requirements for diet and cannot abide by the unified diet or specific allergy history (asthma, urticaria, eczema dermatitis, etc.); those who have allergic rhinitis, or are known to be allergic to any component of the test drug or latex (contained in the syringe needle cover);
* 11.Those who drinking too much tea, coffee and / or caffeinated beverages (more than 8 cups, 1 cup = 250 ml) every day;
* 12. Those who have received any drug treatment (including prescription drugs, over-the-counter drugs, biological products, Traditional Chinese medicine, vitamins, dietary supplements, etc.) and health care products within 14 days before signing the informed consent;
* 13. Traditional Chinese medicine (except proprietary Chinese Medicine) and health care products are planned to be used during the test;
* 14. Have a blood donation history within 3 months before signing the informed consent, or plan to donate blood during the trial;
* 15. Those who plan to accept any biological drugs within 3 months after the administration of the test drug or those who plan to accept monoclonal antibody drugs within 9 months;
* 16. Those who plan to donate sperm within 6 months after the administration of the test drug;
* 17. Those who plan to undergo (including cosmetic surgery, dental surgery and oral surgery) during the trial period;
* 18. Those who plan to take part in strenuous exercise during the experiment, including physical contact exercise or collision exercise;
* 19. Participants in other clinical trials within 3 months before signing the informed consent;
* 20. Vaccinated within 6 months before signing the informed consent;
* 21. In the screening period or baseline period, the researchers think that the physical examination and laboratory examination of the subjects have clinical significance abnormalities; or the following indicators exceed the following standards: the rate of pulse in awake state is less than 50 times / min or more than 100 times / min, the systolic pressure in sitting position is equal to or more than 140 mmHg or the diastolic pressure is more than 90 mmHg, and the ear temperature is more than 37.5 ℃; any one of eosinophil, neutrophil, platelet is beyond the normal range; eGFR is less than 90 mL / min / 1.73m2 (estimated by MDRD formula of kidney disease diet improvement test, see Annex I);
* 22. Patients with clinically significant ECG abnormalities in screening or baseline period, or with QTcF ≥ 450 ms, or with a history of clinically significant ECG abnormalities in the past;
* 23. The results of chest X-rayor chest CT examination or B-ultrasonic examination are clinically significant abnormalities according to the judgment of the researcher;
* 24.Any one of HIV antibody, HBsAg, HBeAg, HBcAg, HCV antibody and Treponema pallidum antibody is positive;
* 25. The researchers think those who are considered by the investigator unsuitable for the trail or who may not be able to complete the trial for other reasons is not suitable to be enrolled or may not be able to complete the experiment for other reasons;
* 26. Employees or relatives of researchers, research centers, sponsors and contract research organizations.

Primary outcomes:
measure: AUC(0 -∞) of single subcutaneous administration of HS632 and Xolair in healthy subjects
timeFrame: 13weeks
measure: Cmax of single subcutaneous administration of HS632 and Xolair in healthy subjects Peak plasma concentration (Cmax) after single subcutaneous administration of HS632 and Xolair in healthy subjects
timeFrame: 13weeks
Secondary outcomes:
measure: AUC (0 - t) of HS632 and Xolair in single subcutaneous administration in healthy subjects
timeFrame: 13weeks
measure: 2.Tmax of single subcutaneous administration of HS632 and Xolair in healthy subjects
timeFrame: 13weeks
measure: 3.CLt/F of single subcutaneous administration of HS632 and Xolair in healthy subjects
timeFrame: 13weeks
measure: Half-life (T1/2) of single subcutaneous administration of HS632 and Xolair in healthy subjects
timeFrame: 13weeks
measure: Vd/F of single subcutaneous administration of HS632 and Xolair in healthy subjects
timeFrame: 13weeks
measure: Incidence of Treatment-Emergent Adverse Events[Safety]
timeFrame: 13weeks
measure: Immunogenicity of single subcutaneous administration of HS632 and Xolair in healthy subjects
timeFrame: 13weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Anhui Peng
state: Shanghai
Study officials:
affiliation: Huashan Hospital
name: Jing Zhang, Dr. Pharm
role: PRINCIPAL_INVESTIGATOR
affiliation: Huashan Hospital
name: Xiaojie Wu, Dr. Pharm
role: PRINCIPAL_INVESTIGATOR
References: