Hengrui tests autoinjector for SHR-1703 in a bridging pharmacokinetics study
The Phase 1 trial compares a pre-filled syringe and an autoinjector for SHR-1703, a device-format study rather than a new efficacy readout.
Executive Summary
- Hengrui is running a pharmacokinetic bridging study to see whether an autoinjector delivers SHR-1703 the same way a pre-filled syringe does, a device question rather than an efficacy one.
- The trial sits in healthy volunteers and carries no disclosed target or mechanism class, so it cannot speak to how SHR-1703 performs in patients or against competing therapies.
- SHR-1703 has one completed and one terminated healthy-volunteer study on record, giving this device-comparison trial a modest history to build from rather than a first-in-human debut.
- Hengrui's broader trial portfolio shows a track record of completing the great majority of its studies, which sets a normal operational baseline for this trial's conduct.
The trial
NCT07701239, titled "A Study Comparing a Pre-filled Safety Syringe and an Autoinjector for SHR-1703 Injection in Healthy Participants," is a Phase 1 interventional study set to enroll 84 healthy volunteers in China. The trial has not yet started recruiting, with a start date of July 1, 2026 and a primary completion date of April 1, 2027. The primary endpoints are pharmacokinetic measures, area under the concentration-time curve extrapolated to infinity, area under the curve to the last quantifiable concentration, and peak concentration (Cmax), each assessed over a 267-day observation window. Secondary endpoints cover clearance, immunogenicity (anti-drug antibodies and neutralizing antibodies), safety and tolerability by adverse-event incidence, and additional pharmacokinetic parameters including half-life and volume of distribution. NCT07701239A Study Comparing a Pre-filled Safety Syringe and an Autoinjector for SHR-1703 Injection in Healthy ParticipantsNCT07701239
What the design tells you
A trial built around AUC and Cmax comparisons between two injection devices, in healthy volunteers, is a bioequivalence-style bridging study. It is designed to establish whether an autoinjector, typically intended for patient self-administration, delivers the drug into the bloodstream the same way a pre-filled syringe does. That is a formulation and delivery question, not a test of whether SHR-1703 treats a disease. The trial is not registrational. NCT07701239A Study Comparing a Pre-filled Safety Syringe and an Autoinjector for SHR-1703 Injection in Healthy ParticipantsNCT07701239
Program history
SHR-1703 has been tested in healthy volunteers before this study. A Phase 1 trial run by Jiangsu HengRui Medicine Co., Ltd. enrolled 42 participants and completed in September 2021. A separate Phase 1 trial run by Atridia Pty Ltd., comparing SHR-1703 against placebo, enrolled a single participant and was terminated the same month. Those two studies are the only prior clinical history for the molecule in healthy volunteers; one completed, one terminated, a count too small to read as a rate.
Competitive field
SHR-1703's target and mechanism class are not established, so no direct comparator can be identified on that basis, and the competitive field surfaced in this indication reflects a broad healthy-volunteer landscape rather than a specific mechanism cohort. Named comparators in that healthy-volunteer search, including dupilumab, fluticasone propionate, and obicetrapib, work through different targets and modalities and are not mechanism peers to SHR-1703. The trial does not compete on a shared biological hypothesis; it competes on delivery-device execution.
Sponsor execution
Guangdong Hengrui Pharmaceutical Co., Ltd has completed 20 of 21 trials with recorded outcomes, a 95% completion rate, and runs 53 trials across all phases and statuses. That execution baseline is favorable and typical for this sponsor; it does not by itself say anything about SHR-1703's clinical profile.
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.