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

NCT07264335 | Active Not Recruiting Phase 1

• 1 other identifier: SHR-1819-105
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

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

  Day 1 - Day 71.

• Peak concentration (Cmax)

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

  Day 1 - Day 71.

Secondary Outcomes (2)

• SHR-1819 Anti-Drug Antibodies (ADA)

  Day1; Day22 ; Day43; Day71.

• Incidence and severity of adverse events (AEs)

  Day 1 - Day 71.

Study Arms (2)

Prefilled Syringe (PFS) Group

EXPERIMENTAL

Drug: SHR-1819 Injection

Artificial Intelligence (AI) Group

EXPERIMENTAL

Drug: SHR-1819 Injection

Interventions

SHR-1819 Injection DRUG

SHR-1819 injection.

Artificial Intelligence (AI) Group; Prefilled Syringe (PFS) Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Understanding the research procedures and methods, being able to complete the research in accordance with the procedure requirements, and sign the informed consent;
• The age on the date of signing the informed consent must be ≥18 years old and ≤55 years old;
• 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;
• 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.

You may not qualify if:

• 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);
• 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;
• 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;
• Subjects who are considered by the investigator to have any other factors which are not suitable for participating in this study.

Sponsors & Collaborators

• Guangdong Hengrui Pharmaceutical Co., Ltd: lead

Study Sites (1)

The First Affiliated Hospital of University of Science and Technology of China

Hefei, Anhui, 230000, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 4, 2025
• Study Start: March 7, 2026
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

CN (1)