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

NCT05370950
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Phase
Phase 1
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Recruitment status
Completed
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Participants
159
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Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
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Start date
2022-05-25
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Number of sites
1
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Summary
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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Short title
Study of Bioavailability, Pharmacodynamics and Safety of SHR-1209 Administered by Single Subcutaneous Injection at Different Sites in Healthy Volunteers
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Official 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
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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
2022-12-31
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First posted
2022-05-12
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Registry last updated
2023-01-12
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Primary completion date
2022-12-31
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Start date
2022-05-25
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Actual participants
159
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Participants
159
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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
Jiangsu HengRui Medicine Co., Ltd.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05370950
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ClinicalTrials.gov ID
NCT05370950
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Basic science
Masking
No masking
Sources for study design
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  1. Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: area under the curve (AUC0-t)

    Timeframe: Days 1-113

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

    Timeframe: Days 1-113

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

    Timeframe: Days 1-113

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

    Timeframe: Days 1-113

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

    Timeframe: Days 1-113

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

    Timeframe: Days 1-113

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

    Timeframe: Days 1-113

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

    Timeframe: Days 1-113

Sources for outcomes
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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 ≥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;
  4. 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.

  1. 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).

  2. 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.

  3. General situation:

    Have a history of drug use or drug abuse; Women who are pregnant or breastfeeding.

  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
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  • The Second Affiliated Hospital of Anhui Medical UniversityHefei, China
Sources for sites
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Sources for references
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Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)