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CompletedNCT07264335Updated Aug 24, 2026

A Study on the Bioavailability of SHR-1819 Injection Administered Subcutaneously Using Different Injection Devices in Healthy Subjects

A Phase 1 interventional study of SHR-1819 Injection in Atopic Dermatitis, sponsored by Guangdong Hengrui Pharmaceutical Co., Ltd. Completed at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-24.

Sponsored by Guangdong Hengrui Pharmaceutical Co., Ltd · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

This study is a randomized, parallel-group, open-label Phase I clinical trial designed to compare the bioavailability and safety of subcutaneous SHR-1819 injection administered via different injection devices in healthy subjects.

02

Conditions studied

  • Atopic Dermatitis

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03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 160 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Guangdong Hengrui Pharmaceutical Co., Ltd is the lead sponsor of 58 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Understanding the research procedures and methods, being able to complete the research in accordance with the procedure requirements, and sign the informed consent;
  2. The age on the date of signing the informed consent must be ≥18 years old and ≤55 years old;
  3. Body mass index (BMI) at screening period must be ≥19.0 kg/m2 and \<26.0 kg/m2, weight of male must≥ 50.0 kg and \<80.0 kg;
  4. The subjects and their female partners are willing to have no reproductive plan from signing the informed consent to 3 months after the last administration of the study drug, and voluntarily take effective contraceptive measures and do not plan to donate sperm or ovum.

Exclusion criteria

Exclusion Criteria:

  1. History of the following diseases or treatments: (1) Receipt of a live-attenuated vaccine within 1 month prior to screening or planned receipt during the study; (2) Previous participation in a clinical trial involving any investigational product (drug or device) within 3 months before screening; (3) History of food or drug allergy or atopic allergic disease (asthma, urticaria);
  2. Any one of the following tests at Screening period or Baseline period: (1) Human immunodeficiency virus antibody (HIV-Ab), syphilis serological examination, hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab) positive; (2) Exclude individuals who have experienced severe trauma or undergone major surgery within the past 6 months, or who plan to undergo surgery during the trial period;
  3. General situation: (1) Have a history of drug use or drug abuse; (2) Investigators, site staff, or any other individuals directly involved in the conduct of the protocol;
  4. Subjects who are considered by the investigator to have any other factors which are not suitable for participating in this study.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
160 participants (actual)

Study arms

  • Experimental
    Prefilled Syringe (PFS) Group

    Drug: SHR-1819 Injection

  • Experimental
    Artificial Intelligence (AI) Group

    Drug: SHR-1819 Injection

Interventions

  • DrugSHR-1819 Injection

    SHR-1819 injection.

06

What researchers measure

Primary outcomes

  1. Area under the serum concentration versus time curve from time zero to the real time of last measurable concentration (AUClast).

    Time frame: Day 1 - Day 71.

  2. Peak concentration (Cmax)

    Pharmacokinetic parameters of multiple-site subcutaneous injection of SHR-1819.

    Time frame: Day 1 - Day 71.

Secondary outcomes

  1. SHR-1819 Anti-Drug Antibodies (ADA)

    Time frame: Day1; Day22 ; Day43; Day71.

  2. Incidence and severity of adverse events (AEs)

    Time frame: Day 1 - Day 71.

07

Study locations

1 site
  • The First Affiliated Hospital of University of Science and Technology of China
    Hefei, Anhui 230000, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07264335
Lead sponsor
Guangdong Hengrui Pharmaceutical Co., Ltd
Responsible party
Sponsor
First posted
Dec 4, 2025
Start date
Mar 7, 2026
Primary completion
Jun 26, 2026
Completion
Jun 26, 2026
Last update
Aug 24, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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