Safety and Tolerability of SHR-1918 in Healthy Subjects

Beijing Suncadia Pharmaceuticals

Status and phase: Active, not recruiting; Phase 1

Conditions: Hyperlipemia

Treatments: Drug: SHR-1918 placebo; Drug: SHR-1918

Study type: Interventional

Funder types: Industry

Identifiers

NCT05432544

SHR-1918-101

Details and patient eligibility

About

The primary objective of this study is to assess the safety and tolerability of SHR-1918 injection in healthy subjects. In addition, this study will provide information on pharmacokinetics and pharmacodynamics of SHR-1918 injection in healthy subjects.

Enrollment: 72 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age ≥18 and ≤65 on the date of signing the informed consent, males or females;
2. 1.7 mmol/L≤TG≤5.6 mmol/L，2.6 mmol/L≤LDL-C<4.9 mmol/L;
3. Understand the study procedures and methods, volunteer to participate in the study, and sign the informed consent.

Exclusion criteria

1.History of disease or treatment for:

1. Known allergic reaction to experimental drugs or severe allergic reaction to other antibody drugs;
2. Malignncy;
3. Combined cardiovascular, hepatic, renal, gastrointestinal, neuropsychiatric, hematological, or metabolic diseases;
4. History of any drug use prior to screening or within 2 weeks prior to baseline

2.Any one of the following tests at screening :

1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or gamma-glutamyl transferase (GGT) exceeding 2 times ULN, or total bilirubin exceeding 1.5 times ULN
2. Creatine kinase (CK) exceeding 3 times the upper limit of normal (ULN)

3.General:

1. History of drug or substance abuse;
2. Average of 5 or more cigarettes per day during the 4 weeks prior to screening;
3. History of blood donation within 3 months prior to screening, or severe blood loss (≥400 mL blood loss), or received a blood transfusion within 4 weeks;
4. Vaccination within 2 weeks prior to screening or planned during the course of the trial

4.The Investigator determines that the subjects have poor compliance or have any factors that may prevent them from participating in the study, including, but not limited to, the study placing the subjects at unacceptable risk or possibly interfering with the study results.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups, including a placebo group

SAD, SHR-1918

Experimental group

Description:

Up to 6 cohorts of healthy subjects will receive a single dose of SHR-1918 injection

Treatment:

Drug: SHR-1918

SAD, SHR-1918 placebo

Placebo Comparator group

Description:

Up to 6 cohorts of healthy subjects will receive a single dose of SHR-1918 placebo injection

Treatment:

Drug: SHR-1918 placebo