Clinical trial NCT05370950: Study of Bioavailability, Pharmacodynamics and Safety of SHR-1209 Administered by Single Subcutaneous Injection at Different Sites in Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypercholesterolemia and Hyperlipidemia
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-05-12
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-center, random, parallel, open-label
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

Primary outcomes:
measure: Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: area under the curve (AUC0-t)
timeFrame: Days 1-113
measure: Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: area under the curve (AUC0-∞)
timeFrame: Days 1-113
measure: Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: peak concentration (Coax)
timeFrame: Days 1-113
Secondary outcomes:
measure: Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: time to peak (Tmax)
timeFrame: Days 1-113
measure: Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: terminal elimination half-life (t1/2)
timeFrame: Days 1-113
measure: Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: apparent volume of distribution (Vz/F)
timeFrame: Days 1-113
measure: Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: apparent clearance (CL/F)
timeFrame: Days 1-113
measure: Incidence and severity of adverse events (AE), serious adverse events (SAE), etc.
timeFrame: Days 1-113
Other outcomes:
Locations:
city: Hefei
country: China
facility: The Second Affiliated Hospital of Anhui Medical University
state: Anhui
Study officials:
References: