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

Hengrui Medicine

Status and phase: Active, not recruiting; Phase 1

Conditions: Hypercholesterolemia and Hyperlipidemia

Treatments: Drug: SHR-1209 single-site subcutaneous injection; Drug: SHR-1209 multiple-site subcutaneous injections

Study type: Interventional

Funder types: Industry

Identifiers

NCT06837077

SHR-1209-105

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Treatment group A

Experimental group

Treatment:

Drug: SHR-1209 multiple-site subcutaneous injections

Drug: SHR-1209 single-site subcutaneous injection

Treatment group B

Experimental group

Treatment:

Drug: SHR-1209 multiple-site subcutaneous injections

Drug: SHR-1209 single-site subcutaneous injection