Clinical trial NCT06837077: Study of SHR-1209 Administered by Single-site or Multiple-site Subcutaneous Injections in Healthy Volunteers
Official 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Hypercholesterolemia and Hyperlipidemia
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-02-20
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


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 ≥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;
4. 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:

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

Primary outcomes:
measure: Visual Analog Scale (VAS) was used to evaluate the injection site pain of single-site subcutaneous injection of SHR-1209.
timeFrame: After injection in day 1 and day 57.
measure: Visual Analog Scale (VAS) was used to evaluate the injection site pain of multiple-site subcutaneous injections of SHR-1209.
timeFrame: After injections in day 1 and day 57.
measure: Area under the curve (AUC0-56).
timeFrame: After injection in day 1 up to day 56.
measure: Peak time (Tmax) of SHR-1209.
timeFrame: After injection in day 1 up to day 56.
measure: Peak concentration (Cmax) of SHR-1209.
timeFrame: After injection in day 1 up to day 56.
Secondary outcomes:
measure: Subjects' preferred method of SHR-1209 administration between the tested injection regimens.
timeFrame: Day 68.
measure: Incidence and severity of adverse events (AEs).
timeFrame: From Day 1 to Day 169.
measure: Incidence and severity of serious adverse events (SAEs).
timeFrame: From Day 1 to Day 169.
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of USTC
state: Anhui
Study officials:
References: