Asthma With Eosinophilic PhenotypePhase 1NCT07701239
A Study Comparing a Pre-filled Safety Syringe and an Autoinjector for SHR-1703 Injection in Healthy Participants
A Phase 1 study testing SHR-1703 Injection in people with Asthma With Eosinophilic Phenotype, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
This is a single-center, randomized, parallel-group, open-label clinical study designed to compare the bioavailability and safety of SHR-1703 Injection administered subcutaneously using a pre-filled safety syringe (PFS) or a pre-filled autoinjector (AI) in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma With Eosinophilic Phenotype
- What is being tested?
- SHR-1703 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- Jul 2026to Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18-55 years at ICF signing.
- Screening BMI 19-26 kg/m², weight 50-80 kg.
- Normal or NCS findings at screening/baseline: physical exam, lab tests (CBC, blood chemistry, UA, coagulation), ECG, abdominal ultrasound, chest X-ray.
- 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.
- 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).
- 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.
Who cannot join
- AST, ALT, or bilirubin > ULN at screening/baseline.
- eGFR < 90 mL/min/1.73m² at screening/baseline.
- Clinically significant abnormal blood pressure (SBP >140 or <90 mmHg; DBP >90 or <60 mmHg) at screening/baseline.
- Positive for HBsAg, HBcAb with HBV-DNA > ULN, HIV-Ab, syphilis serology, or HCV-Ab at screening.
- Suspected or confirmed active tuberculosis (clinical symptoms or imaging evidence within 3 months).
- QTcF > 450 ms on repeated 12-lead ECG at screening/baseline.
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- 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).
- 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.
- Major trauma or surgery within 6 months prior to screening, or planned surgery during the study.
- Blood donation or significant blood loss (≥400 mL) within 1 month, or blood transfusion within 2 months prior to screening.
- Receipt or planned receipt of live (attenuated) vaccine within 1 month prior to dosing or during the study.
- Suspected or confirmed parasitic infection within 6 months prior to screening.
- Pregnant or breastfeeding women, or positive pregnancy test (HCG).
- Investigator or site personnel directly involved in the study.
- Any other condition deemed by the investigator to preclude study participation or increase risk to the participant.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital ， Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Xingjiang Hu
About this study
Official title: A Study to Evaluate the Relative Bioavailability of SHR-1703 Injection Following Subcutaneous Administration Via a Prefilled Safety Syringe and a Prefilled Autoinjector in Healthy Participants
This is a single-center, randomized, parallel-group, open-label clinical study designed to compare the bioavailability and safety of SHR-1703 Injection administered subcutaneously using a pre-filled safety syringe (PFS) or a pre-filled autoinjector (AI) in healthy participants.
A total of 84 healthy participants are planned to be enrolled and randomized in a 1:1 ratio to either the PFS group or the AI group. Participants in the PFS group will receive a single subcutaneous injection of SHR-1703 Injection using a pre-filled safety syringe, while participants in the AI group will receive a single subcutaneous injection of SHR-1703 Injection using a pre-filled autoinjector.
- Conditions
- Asthma With Eosinophilic Phenotype
- Being tested
- SHR-1703 Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1703 InjectionDrug
A single subcutaneous dose of SHR-1703 Injection administered via pre-filled safety syringe.
SHR-1703 InjectionDrug
A single subcutaneous dose of SHR-1703 Injection administered via autoinjector.
| Study group | Role | What they receive |
|---|---|---|
| PFS Group (n=42) | Experimental | Not described Receives: Drug: SHR-1703 Injection |
| AI Group (n=42) | Experimental | Not described Receives: Drug: SHR-1703 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
peak concentration (Cmax)
Measured: Days 1-267
area under the serum concentration-time curve from time zero to the last quantifiable concentration (AUC0-t),
Measured: Days 1-267
area under the serum concentration-time curve from time zero extrapolated to infinity (AUC0-∞)
Measured: Days 1-267
Secondary outcomes (6)
Tmax,
Measured: Days 1-267
t1/2
Measured: Days 1-267
CL/F,
Measured: Days 1-267
Vz/F.
Measured: Days 1-267
Safety and tolerability as assessed by the incidence and severity of AEs,
Measured: Days 1-267
Immunogenicity of SHR-1703 as assessed by the presence and incidence of anti-drug antibodies (ADAs) and, if applicable, neutralizing antibodies (NAbs).
Measured: Days 1-267
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma With Eosinophilic PhenotypeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07701239
- Sponsor's protocol ID
- SHR-1703-105
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Relative Bioavailability of SHR-1703 Injection Following Subcutaneous Administration Via a Prefilled Safety Syringe and a Prefilled Autoinjector in Healthy Participants
- ClinicalTrials.gov ID
- NCT07701239
- Acronym / sponsor ID
- SHR-1703-105
- Conditions
- Asthma With Eosinophilic Phenotype
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Jul 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, randomized, parallel-group, open-label clinical study designed to compare the bioavailability and safety of SHR-1703 Injection administered subcutaneously using a pre-filled safety syringe (PFS) or a pre-filled autoinjector (AI) in healthy participants.
A total of 84 healthy participants are planned to be enrolled and randomized in a 1:1 ratio to either the PFS group or the AI group. Participants in the PFS group will receive a single subcutaneous injection of SHR-1703 Injection using a pre-filled safety syringe, while participants in the AI group will receive a single subcutaneous injection of SHR-1703 Injection using a pre-filled autoinjector.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PFS Group (n=42) | Experimental | Drug: SHR-1703 Injection |
| AI Group (n=42) | Experimental | Drug: SHR-1703 Injection |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Aged 18-55 years at ICF signing.
- Screening BMI 19-26 kg/m², weight 50-80 kg.
- Normal or NCS findings at screening/baseline: physical exam, lab tests (CBC, blood chemistry, UA, coagulation), ECG, abdominal ultrasound, chest X-ray.
- 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.
- 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).
Key exclusion criteria (15 listed)
- AST, ALT, or bilirubin > ULN at screening/baseline.
- eGFR < 90 mL/min/1.73m² at screening/baseline.
- Clinically significant abnormal blood pressure (SBP >140 or <90 mmHg; DBP >90 or <60 mmHg) at screening/baseline.
- Positive for HBsAg, HBcAb with HBV-DNA > ULN, HIV-Ab, syphilis serology, or HCV-Ab at screening.
- Suspected or confirmed active tuberculosis (clinical symptoms or imaging evidence within 3 months).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-1703 InjectionA single subcutaneous dose of SHR-1703 Injection administered via pre-filled safety syringe. | Drug | PFS Group (n=42) |
| SHR-1703 InjectionA single subcutaneous dose of SHR-1703 Injection administered via autoinjector. | Drug | AI Group (n=42) |
Primary outcome
peak concentration (Cmax)
Time frame: Days 1-267
area under the serum concentration-time curve from time zero to the last quantifiable concentration (AUC0-t),
Time frame: Days 1-267
area under the serum concentration-time curve from time zero extrapolated to infinity (AUC0-∞)
Time frame: Days 1-267
6 secondary outcomes
Tmax,
Time frame: Days 1-267
t1/2
Time frame: Days 1-267
CL/F,
Time frame: Days 1-267
Vz/F.
Time frame: Days 1-267
Safety and tolerability as assessed by the incidence and severity of AEs,
Time frame: Days 1-267
Immunogenicity of SHR-1703 as assessed by the presence and incidence of anti-drug antibodies (ADAs) and, if applicable, neutralizing antibodies (NAbs).
Time frame: Days 1-267
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHR-1703 Injection in people with Asthma With Eosinophilic Phenotype, run by Guangdong Hengrui 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 6 inclusion and 15 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: opening soon, as of the sponsor's last update on 14 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenzheng Xiong (+86 13616029339, wenzheng.xiong.wx10@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peak concentration (Cmax) (time frame: Days 1-267). 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?
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 14 Jul 2026; AzTrials last refreshed its copy on 29 Oct 2026.