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Similarity of Pharmacokinetics and SafetyPhase 1NCT04361812

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

A Phase 1 study testing HS632 and Omalizumab (Xolair®) in people with Similarity of Pharmacokinetics and Safety, run by BioRay Pharmaceutical Co., Ltd. at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 40 years, men onlyHealthy volunteers can take part
What is being tested?
HS632 and Omalizumab (Xolair®)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteChina
Study dates
15 Oct 2020to 31 Dec 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Anhui Peng

    Shanghai, Shanghai Municipality, 200040

Other trials in China

About this study

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

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

Read the 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.

Being tested
HS632, Omalizumab (Xolair®)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HS632Drug

    Also called Recombinant anti IgE humanized monoclonal antibody 150mg

    Subcutaneous injection of HS632

  • Omalizumab (Xolair®)Drug

    Also called Omalizumab 150mg

    Subcutaneous injection of Omalizumab Xolair®)

Study groups in NCT04361812
Study groupRoleWhat they receive
HS632ExperimentalHS632 150mg for a single subcutaneous injection
Receives: Drug: HS632
Omalizumab (Xolair®)Active comparatorOmalizumab 150mg for a single subcutaneous injection
Receives: Drug: Omalizumab (Xolair®)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 13weeks

  2. 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

    Measured: 13weeks

Secondary outcomes (7)

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

    Area under the plasma concentration versus time curve (AUC) from 0 to the last selected time point, i.e. 2184h after the injection

    Measured: 13weeks

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

    Time to Cmax (Tmax) of single subcutaneous administration of HS632 and Xolair in healthy subjects

    Measured: 13weeks

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

    Total clearance corrected by bioavailability (CLt/F) of single subcutaneous administration of HS632 and Xolair in healthy subjects

    Measured: 13weeks

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

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

    Measured: 13weeks

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

    Apparent volume of distribution corrected by bioavailability (Vd/F) of single subcutaneous administration of HS632 and Xolair in healthy subjects

    Measured: 13weeks

  6. Incidence of Treatment-Emergent Adverse Events[Safety]

    Incidence of Treatment-Emergent Adverse Events [Safety] of distribution corrected by bioavailability (Vd/F) of single subcutaneous administration of HS632 and Xolair in healthy subjects

    Measured: 13weeks

  7. Immunogenicity of single subcutaneous administration of HS632 and Xolair in healthy subjects

    Anti drug antibody（ADA）of single subcutaneous administration of HS632 and Xolair in healthy subjects

    Measured: 13weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2020
  2. Study start15 Oct 2020
  3. Primary completion31 Dec 2021
  4. Study completion31 Dec 2021

Why it stopped: Company R\&D Strategy Adjustment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04361812
Sponsor's protocol ID
HS632-I
Status last verified
Nov 2025
First submitted
14 Apr 2020
Last updated
21 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HS632 and Omalizumab (Xolair®) in people with Similarity of Pharmacokinetics and Safety, run by BioRay Pharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Company R\&D Strategy Adjustment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUC(0 -∞) of single subcutaneous administration of HS632 and Xolair in healthy subjects (time frame: 13weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04361812.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.

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