Easier injections for asthma? study tests two delivery methods
NCT ID NCT07701239
First seen Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time
Summary
This study tests whether a prefilled autoinjector delivers the drug SHR-1703 as effectively as a standard prefilled syringe in healthy adults. The goal is to see if the autoinjector provides a similar level of drug in the blood, which could make future injections easier for people with eosinophilic asthma. Participants receive a single dose of SHR-1703 by either method, and researchers compare drug levels and safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SHR-1703 injection
- What this could lead to
- If successful, this could lead to a more convenient way for patients to receive SHR-1703, potentially improving ease of use for asthma treatment.
- What could go wrong
- This is an early-phase study in healthy people, not patients, so results may not directly translate to real-world use or show how well the drug works for asthma.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 84 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged 18-55 years at ICF signing. 2. Screening BMI 19-26 kg/m², weight 50-80 kg. 3. Normal or NCS findings at screening/baseline: physical exam, lab tests (CBC, blood chemistry, UA, coagulation), ECG, abdominal ultrasound, chest X-ray. 4. Investigator-assessed absence of diseases that could significantly impact the study or pose additional health risks; stable health expected, no medical intervention needed. Clinically significant lab abnormalities may be retested within 1 week if justified; retest results determine eligibility. 5. Females of childbearing potential and males with female partners of childbearing potential must avoid sperm/egg donation, have no pregnancy plan, and use appropriate contraception from ICF signing through 14 months post-last dose (see Section 13.1.2). 6. No heavy smoking (\<5 cigarettes/day) or alcohol abuse (≤15 g/day \[e.g., 450 mL beer, 150 mL wine, or 50 mL low-alcohol liquor\], ≤2×/week) within 6 months pre-screening; no drug abuse history. Negative drug screen and alcohol breath test at baseline. Exclusion Criteria: 1. AST, ALT, or bilirubin \> ULN at screening/baseline. 2. eGFR \< 90 mL/min/1.73m² at screening/baseline. 3. Clinically significant abnormal blood pressure (SBP \>140 or \<90 mmHg; DBP \>90 or \<60 mmHg) at screening/baseline. 4. Positive for HBsAg, HBcAb with HBV-DNA \> ULN, HIV-Ab, syphilis serology, or HCV-Ab at screening. 5. Suspected or confirmed active tuberculosis (clinical symptoms or imaging evidence within 3 months). 6. QTcF \> 450 ms on repeated 12-lead ECG at screening/baseline. 7. Participation in another drug/device clinical trial within 3 months prior to screening (defined as signed ICF and received study drug/device, or still in follow-up or within 5 half-lives of prior investigational drug, whichever is longer). 8. Use of any prescription drugs, OTC drugs, or herbal medicines within 1 month prior to dosing (except routine vitamins ≤100% RDA or occasional paracetamol ≤2 g/day for ≤5 days/month), or less than 5 half-lives washout. 9. Major trauma or surgery within 6 months prior to screening, or planned surgery during the study. 10. Blood donation or significant blood loss (≥400 mL) within 1 month, or blood transfusion within 2 months prior to screening. 11. Receipt or planned receipt of live (attenuated) vaccine within 1 month prior to dosing or during the study. 12. Suspected or confirmed parasitic infection within 6 months prior to screening. 13. Pregnant or breastfeeding women, or positive pregnancy test (HCG). 14. Investigator or site personnel directly involved in the study. 15. Any other condition deemed by the investigator to preclude study participation or increase risk to the participant.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The First Affiliated Hospital , Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000, China
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