A Study Comparing a Pre-filled Safety Syringe and an Autoinjector for SHR-1703 Injection in Healt… (NCT07701239) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Study Comparing a Pre-filled Safety Syringe and an Autoinjector for SHR-1703 Injection in Healthy Participants
China84 participantsStarted 2026-07
Plain-language 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.
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.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
peak concentration (Cmax)
Timeframe: Days 1-267
2
area under the serum concentration-time curve from time zero to the last quantifiable concentration (AUC0-t),
Timeframe: Days 1-267
3
area under the serum concentration-time curve from time zero extrapolated to infinity (AUC0-∞)
. 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
. 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.
. 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.