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AsthmaPhase 1NCT05042401

A Trial of SHR-1703 in Asthma

A Phase 1 study testing SHR-1703 in people with Asthma, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

SHR-1703 is a monoclonal antibody under development for severe asthma. This study is the first study in patients with asthma. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics ，pharmacodynamics and immunogenic characteristics of multiple subcutaneous injections of SHR-1703 in… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Asthma
What is being tested?
SHR-1703
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
23 participants
Where
1 siteChina
Study dates
12 Oct 2021to 15 Jun 2023
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
  • Able to read, comprehend and write at a sufficient level to complete study materials.
  • Aged 18 to 65 years (inclusive).
  • Body weight equal or more than 40.0 kg.
  • Diagnosis of asthma
  • The condition was stable 4 weeks before screening, and no drugs or standard asthma drugs were used. Treatment medications include asthma maintenance medications and/or emergency relief medications as needed. If the use of asthma maintenance treatment drugs, it is necessary to maintain a stable usage and dosage and stable condition. Asthma maintenance medications include one or more of inhaled corticosteroids (ICS), inhaled long-acting beta2 agonists (LABA), and inhaled long-acting cholinergic receptor antagonists (LAMA). Emergency relief drugs are limited to short-acting β2 receptor agonists (SABA) or short-acting cholinergic receptor antagonists (SAMA) inhaled on demand;
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  • Serum eosinophil count at screening and baseline ≥0.15/L;
  • Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and total bilirubin were less than the upper limit of normal range (ULN) during screening;
  • During the screening period, the FEV1/ estimated value of lung function test before bronchodilators was ≥45% (the examination time was between 6:00 a.m. and 12:00 a.m.), and the short-acting bronchodilators were stopped for at least 4 hours before the examination;
  • Subjects (including partners) had no family planning and were voluntarily using effective contraceptives during the study period and during the last visit (see appendix for specific contraceptives).

Who cannot join

  • People who are allergic to IL-5 antibody drugs and excipients or other biological agents;
  • Patients with diseases other than asthma that lead to elevated blood eosinophilic granulomatosis, including but not limited to eosinophilic granulomatosis with polyangiitis (EGPA), eosinophilic esophagitis, etc.;
  • Have a history or history of clinically significant lung diseases other than asthma, including active pulmonary tuberculosis, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, chronic obstructive pulmonary disease, lung cancer, etc.;
  • ≥1 clinically significant exacerbation of asthma within 4 weeks prior to screening or within the screening period (clinically significant exacerbation of asthma was defined as ≥3 days of systemic glucocorticosteroid treatment and/or exacerbation of asthma requiring emergency department visits and hospitalization);
  • A life-threatening acute exacerbation of asthma occurred within 5 years prior to screening. Acute episodes of life-threatening asthma were defined as requiring intubation and/or hypercapnia, respiratory arrest or disturbance of consciousness;
  • Bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear, occurring within 4 weeks prior to baseline, resulting in changes in asthma management or, in the investigator's opinion, possible changes that are expected to affect subjects' asthma status or their ability to participate in the study;
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  • Patients with a history of malignant tumor;
  • The combination of other disease states and/or medical interventions that interfere with clinical research. Interference with clinical studies includes but is not limited to interference with liver and kidney function and other safety data analysis, blood eosinophil level analysis, etc
  • Hepatitis B virus surface antigen (HBsAg), human immunodeficiency virus antibody (HIV-AB), syphilis serological test, hepatitis C virus antibody (HCV-AB) were positive during screening;
  • Participants in any drug clinical trial within 3 months prior to baseline were defined as: participants in the trial drug (excluding placebo); Or they are still in the follow-up period of a clinical study or within the 5 half-life of the investigational drug, whichever is longer, before screening;
  • Received any biologic treatment for inflammatory disease in the 6 months prior to baseline that affected asthma and/or blood eosinophil levels, or did not exceed 5 half-lives, whichever is longer;
  • Regular systemic use of glucocorticoids for conditions other than asthma during the 6 months prior to baseline;
  • Before using the study drug use within 14 days of any interference on clinical studies (including but not limited to affect kidney function, blood eosinophil level, etc.) of drugs (including prescription drugs, over-the-counter drugs, Chinese herbal medicine and dietary supplements, etc.), or use of drugs is not more than five half-life of longer (in); Prescription drugs include but are not limited to: Penicillin and cephalosporin, sulfa, tetracycline, granulocyte macrophage colony stimulating factor (gm-csf), interleukin 2 (IL 2) and ranitidine non-steroidal anti-inflammatory drugs, ureide within, allopurinol, b, L - tryptophan, willow nitrogen sulfonyl pyridine, carbamazepine, hydrochlorothiazide, ring spore, nevirapine, clozapine, o o n peace made pp azole, etc .
  • Blood donation history within 1 month before screening, or severe blood loss (total blood volume ≥400 mL), or received blood transfusion within 2 months;
  • Those who receive live (attenuated) vaccine within 1 month prior to screening or plan to receive live (attenuated) vaccine during the test;
  • Suspected parasitic infection/infection within 6 months prior to screening;
  • Pregnancy status (defined as a state from conception to termination of pregnancy and positive for human chorionic gonadotropin) or breastfeeding;
  • Previous smokers who had smoked for 6 months prior to screening or who had quit smoking for more than 6 months at the time of screening had smoked more than 10 pack-years (pack-years = number of years of smoking × number of packs per day). Alcohol consumption within 3 months prior to screening (average consumption of ≥14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 m1 of wine). Have a history of substance abuse within 5 years;
  • Positive smoke screen, drug screen and alcohol breath test during screening;
  • Researchers and related staff of the research center or others directly involved in the implementation of the program;
  • The investigator considers that there are any other factors that may cause the subject to fail to complete the study or present a significant risk to the subject.

Trial locations and contacts

1 site in 1 country.

China1 site

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610044

Other trials in China

About this study

Official title: Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of a Single Subcutaneous Injection of SHR-1703 in Patients With Asthma -- a Randomized, Double-blind, Dose-increasing, Placebo Controlled Phase I Clinical Study

SHR-1703 is a monoclonal antibody under development for severe asthma. This study is the first study in patients with asthma. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics ，pharmacodynamics and immunogenic characteristics of multiple subcutaneous injections of SHR-1703 in asthmatic patients.

Conditions
Asthma
Being tested
SHR-1703, placebo
Medical subject headings
Asthma

What participants receive

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

  • SHR-1703Drug

    SHR-1703 low dose

  • placeboDrug

    placebo low dose

  • SHR-1703Drug

    SHR-1703 high dose

  • placeboDrug

    placebo high dose

Study groups in NCT05042401
Study groupRoleWhat they receive
Treatment group AExperimentalNot described
Receives: Drug: SHR-1703
Treatment group BPlacebo comparatorNot described
Receives: Drug: placebo
Treatment group CExperimentalNot described
Receives: Drug: SHR-1703
Treatment group DPlacebo comparatorNot described
Receives: Drug: placebo

What is being measured

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

  1. The incidence of adverse events of SHR-1703

    Measured: From Day 1 to Day 281

  2. Severity of adverse events of SHR-1703

    Measured: From Day 1 to Day 281

  3. Tolerability of adverse events of SHR-1703

    Measured: From Day 1 to Day 281

Secondary outcomes (8)

  1. Evaluate the concentrations of multiple subcutaneous injections of SHR-1703 in asthmatic patients

    Measured: From Day 1 to Day 281

  2. The percentage change of absolute eosinophil count from baseline

    Measured: From Day 1 to Day 281

  3. Incidence of SHR-1703 immunogenicity

    Measured: From Day 1 to Day 281

  4. Occurrence time of SHR-1703 immunogenicity

    Measured: From Day 1 to Day 281

  5. Duration of anti drug antibody (ADA) of SHR-1703

    Measured: From Day 1 to Day 281

  6. Titer of anti drug antibody (ADA) of SHR-1703

    Measured: From Day 1 to Day 281

  7. The percentage change of forced expiratory volume in 1 second from baseline

    Measured: From Day 1 to Day 281

  8. The percentage change of forced vital capacity from baseline

    Measured: From Day 1 to Day 281

Timeline

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

  1. First posted13 Sep 2021
  2. Study start12 Oct 2021
  3. Primary completion15 Jun 2023 (estimated)
  4. Study completion15 Jun 2023 (estimated)

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
Sequential
Model description
SHR-1703 low dose VS. placebo low dose. SHR-1703 high dose VS. placebo high dose
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05042401
Sponsor's protocol ID
SHR-1703-103
Status last verified
Jun 2022
First submitted
20 Jul 2021
Last updated
25 Apr 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SHR-1703 in people with Asthma, run by Jiangsu HengRui Medicine 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 10 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 25 Apr 2023. 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. Some participants in this study may receive a placebo. 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?

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?

The incidence of adverse events of SHR-1703 (time frame: From Day 1 to Day 281). The study lists 3 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 NCT05042401.

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 25 Apr 2023.

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