Safety and Tolerability of SHR-1918 in Healthy Subjects

NCT ID: NCT05432544

Last Updated: 2023-07-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-27
• Study Completion Date: 2023-12-12

Brief Summary

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.

Conditions

Hyperlipemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

SAD, SHR-1918

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

Group Type: EXPERIMENTAL

SHR-1918

Intervention Type: DRUG

Ascending dose

SAD, SHR-1918 placebo

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

Group Type: PLACEBO_COMPARATOR

SHR-1918 placebo

Intervention Type: DRUG

Ascending dose

Interventions

SHR-1918

Ascending dose

Intervention Type: DRUG

SHR-1918 placebo

Ascending dose

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beijing Suncadia Pharmaceuticals Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Countries

China

References

Qin R, Ye L, Duan L, Li M, He W, Mei X, Li D, Jin R, Lv C, Zhu M, Wang S, Xie Z. SHR-1918, A Monoclonal Antibody Against Angiopoietin-Like 3, in Healthy Subjects: A Randomized, Double-Blind, Placebo-Controlled Study. Clin Pharmacokinet. 2025 Aug;64(8):1245-1253. doi: 10.1007/s40262-025-01539-8. Epub 2025 Jun 27.

Reference Type: DERIVED

PMID: 40576753 (View on PubMed)

Other Identifiers

SHR-1918-101

Identifier Type: -

Identifier Source: org_study_id