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

NCT07264335
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Phase
Phase 1
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Recruitment status
Completed
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Participants
160
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Lead sponsor
Guangdong Hengrui Pharmaceutical Co., Ltd
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Start date
2026-03-07
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Number of sites
1
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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.
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Short title
A Study on the Bioavailability of SHR-1819 Injection Administered Subcutaneously Using Different Injection Devices in Healthy Subjects
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Official title
A Randomized, Open-Label, Parallel-Group Clinical Study to Evaluate the Bioavailability and Safety of Subcutaneous SHR-1819 Injection Administered Using Different Injection Devices in Healthy Subjects
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 1
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Study type
Interventional
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Completion date
2026-06-26
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First posted
2025-12-04
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Registry last updated
2026-08-24
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Primary completion date
2026-06-26
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Start date
2026-03-07
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Actual participants
160
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Participants
160
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Participant count basis
Actual
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Protocol amendments
1
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Number of sites
1
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Registry sponsor category
Industry
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Lead sponsor
Guangdong Hengrui Pharmaceutical Co., Ltd
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07264335
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ClinicalTrials.gov ID
NCT07264335
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Area under the serum concentration versus time curve from time zero to the real time of last measurable concentration (AUClast).

    Timeframe: Day 1 - Day 71.

  2. Peak concentration (Cmax)

    Timeframe: Day 1 - Day 71.

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

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

    Timeframe: Day1; Day22 ; Day43; Day71.

  2. Incidence and severity of adverse events (AEs)

    Timeframe: Day 1 - Day 71.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults
Minimum age
18 Years
Maximum age
55 Years
Healthy volunteers
Yes

  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.

  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.
Sources for eligibility
clinicaltrials.gov

  • The First Affiliated Hospital of University of Science and Technology of ChinaHefei, China
Sources for sites
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Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)