Comparison of Pharmacokinetics and Safety of HS632 and Xolair® With a Single Injection

NCT04361812 | Terminated Phase 1

• 1 other identifier: HS632-I
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Similarity of Pharmacokinetics and Safety

Outcome Measures

Primary Outcomes (2)

• AUC(0 -∞) of single subcutaneous administration of HS632 and Xolair in healthy subjects

  Area Under the concentration-time Curve from time zero to infinity of single subcutaneous administration of HS632 and Xolair in healthy subjects

  13weeks

• 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

  Maximum serum concentration (Cmax) of HS632 and Xolair in healthy subjects Peak plasma concentration (Cmax) after single subcutaneous administration of HS632 and Xolair in healthy subjects

  13weeks

Secondary Outcomes (7)

• AUC (0 - t) of HS632 and Xolair in single subcutaneous administration in healthy subjects

  13weeks

• 2.Tmax of single subcutaneous administration of HS632 and Xolair in healthy subjects

  13weeks

• 3.CLt/F of single subcutaneous administration of HS632 and Xolair in healthy subjects

  13weeks

• Half-life (T1/2) of single subcutaneous administration of HS632 and Xolair in healthy subjects

  13weeks

• Vd/F of single subcutaneous administration of HS632 and Xolair in healthy subjects

  13weeks

Study Arms (2)

HS632

EXPERIMENTAL

HS632 150mg for a single subcutaneous injection

Drug: HS632

Omalizumab (Xolair®)

ACTIVE COMPARATOR

Omalizumab 150mg for a single subcutaneous injection

Drug: Omalizumab (Xolair®)

Interventions

HS632 DRUG

Subcutaneous injection of HS632

Also known as: Recombinant anti IgE humanized monoclonal antibody 150mg

HS632

Omalizumab (Xolair®) DRUG

Subcutaneous injection of Omalizumab Xolair®)

Also known as: Omalizumab 150mg

Omalizumab (Xolair®)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signing the informed consent and being able to complete the test according to the plan;
• Age ≥ 18 and ≤ 40 (subject to the date of signing the informed consent), male;
• 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);
• 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)

You may not qualify if:

• 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;
• Patients with severe bleeding factors affecting venous blood collection
• Skin diseases or other diseases affecting subcutaneous injection;
• \. Patients with upper respiratory tract infection or other acute infection in the 2 weeks prior to screening;
• Patients with history of malignant tumor;
• Those who have undergone surgery within two months before signing the informed consent;
• 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;
• 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);
• \. 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;
• 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);
• Those who drinking too much tea, coffee and / or caffeinated beverages (more than 8 cups, 1 cup = 250 ml) every day;
• \. 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;
• \. Traditional Chinese medicine (except proprietary Chinese Medicine) and health care products are planned to be used during the test;
• \. Have a blood donation history within 3 months before signing the informed consent, or plan to donate blood during the trial;
• \. 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;

Sponsors & Collaborators

• BioRay Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Anhui Peng

Shanghai, Shanghai Municipality, 200040, China

Location

MeSH Terms

Interventions

Omalizumab

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Officials

• Jing Zhang, Dr. Pharm

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

• Xiaojie Wu, Dr. Pharm

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 24, 2020
• Study Start: October 15, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)