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Completed

NCT Number: NCT05370950

Study of Bioavailability, Pharmacodynamics and Safety of SHR-1209 Administered by Single Subcutaneous Injection at Different Sites in Healthy Volunteers

In order to meet the preferences and needs of different patients for injection sites and improve the medication compliance of patients, it is planned to compare the bioavailability, pharmacokinetics, pharmacodynamic and safety data to assess feasibility of multiple injection sites 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 Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230601, 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 ≥18.5 kg/m2 and <30.0 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 2 weeks before screening to 6 months after the administration of the study drug, and voluntarily take effective contraceptive measures and do not plan to donate sperm or ovum.

Exclusion criteria

  • History of the following diseases or treatments:

Diseases that affect drug absorption, distribution, metabolism, and excretion determined by the investigator; Serious infection within 3 months before screening; History of drug allergy or atopic allergic disease (asthma, urticaria).

  • Any one of the following tests at Screening period or Baseline period:

Human immunodeficiency virus antibody (HIV-Ab), syphilis serological examination, hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab) positive; Positive blood pregnancy test.

  • General situation:

Have a history of drug use or 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

Drug

SHR-1209,single subcutaneous injection of 450mg

Primary outcomes

  1. Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: area under the curve (AUC0-t)

    Time frame: Days 1-113

  2. Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: area under the curve (AUC0-∞)

    Time frame: Days 1-113

  3. Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: peak concentration (Coax)

    Time frame: Days 1-113

Secondary outcomes

  1. Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: time to peak (Tmax)

    Time frame: Days 1-113

  2. Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: terminal elimination half-life (t1/2)

    Time frame: Days 1-113

  3. Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: apparent volume of distribution (Vz/F)

    Time frame: Days 1-113

  4. Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: apparent clearance (CL/F)

    Time frame: Days 1-113

  5. Incidence and severity of adverse events (AE), serious adverse events (SAE), etc.

    Time frame: Days 1-113

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

A Single-center, Randomized, Parallel, Open-label Study to Compare the Bioavailability, Pharmacodynamics, and Safety of SHR-1209 Given as Single Subcutaneous Injection at Different Sites in Healthy Volunteers

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 12, 2022
Registry last updated
Jan 12, 2023

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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