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Completed

NCT Number: NCT06837077

Study of SHR-1209 Administered by Single-site or Multiple-site Subcutaneous Injections in Healthy Volunteers

In order to improve the medication convenience and compliance of patients and facilitates in the long-term control of disease condition, it is planned to reduced the number of injections to one per administration. The study aims to compare the safety and pharmacokinetics data to assess feasibility of single-site and multiple-site injection for administration.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The First Affiliated Hospital of USTC

Hefei, Anhui, 230000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 <28.0 kg/m2, weight of male must≥ 50.0 kg and <90.0 kg, and female≥ 45.0 kg and <90.0 kg;
  • The subjects and their female partners are willing to have no reproductive plan from signing the informed consent to 16 weeks 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

  • Serious infection within 3 months before screening;
  • History of food or drug allergy or atopic allergic disease (asthma, urticaria);
  • Positive blood pregnancy test;
  • Have a history of drug abuse;
  • Women who are pregnant or breastfeeding;
  • Subjects who are considered by the investigator to have any other factors which are not suitable for participating in this study.

Treatment and study plan

SHR-1209 single-site subcutaneous injection

Drug

SHR-1209 single-site subcutaneous injection.

SHR-1209 multiple-site subcutaneous injections

Drug

SHR-1209 multiple-site subcutaneous injections.

Primary outcomes

  1. Visual Analog Scale (VAS) was used to evaluate the injection site pain of single-site subcutaneous injection of SHR-1209.

    Time frame: After injection in day 1 and day 57.

  2. Visual Analog Scale (VAS) was used to evaluate the injection site pain of multiple-site subcutaneous injections of SHR-1209.

    Time frame: After injections in day 1 and day 57.

  3. Area under the curve (AUC0-56).

    Time frame: After injection in day 1 up to day 56.

  4. Peak time (Tmax) of SHR-1209.

    Time frame: After injection in day 1 up to day 56.

  5. Peak concentration (Cmax) of SHR-1209.

    Time frame: After injection in day 1 up to day 56.

Secondary outcomes

  1. Subjects' preferred method of SHR-1209 administration between the tested injection regimens.

    Time frame: Day 68.

  2. Incidence and severity of adverse events (AEs).

    Time frame: From Day 1 to Day 169.

  3. Incidence and severity of serious adverse events (SAEs).

    Time frame: From Day 1 to Day 169.

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

A Single-center, Randomized, Crossover, Open-label Phase I Study to Compare the Safety and Pharmacokinetics of SHR-1209 Given as Single-site or Multiple-site Subcutaneous Injections in Healthy Volunteers

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 20, 2025
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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