Safety and Tolerability of SHR-1918 in Healthy Subjects

NCT05432544 | Unknown Phase 1

• 1 other identifier: SHR-1918-101
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• To assess the number of subjects with adverse events (AEs)

  up to day 190

• To assess the number of subjects with serious adverse events (SAEs)

  up to day 190

Secondary Outcomes (16)

• To assess AUC0-t

  up to day 190

• To assess AUC0-∞

  up to day 190

• To assess Tmax

  up to day 190

• To assess Cmax

  up to day 190

• To assess t1/2

  up to day 190

Study Arms (2)

SAD, SHR-1918

EXPERIMENTAL

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

Drug: SHR-1918

SAD, SHR-1918 placebo

PLACEBO COMPARATOR

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

Drug: SHR-1918 placebo

Interventions

SHR-1918 DRUG

Ascending dose

SAD, SHR-1918

SHR-1918 placebo DRUG

Ascending dose

SAD, SHR-1918 placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• History of disease or treatment for:
• Known allergic reaction to experimental drugs or severe allergic reaction to other antibody drugs;
• Malignncy;
• Combined cardiovascular, hepatic, renal, gastrointestinal, neuropsychiatric, hematological, or metabolic diseases;
• History of any drug use prior to screening or within 2 weeks prior to baseline
• Any one of the following tests at screening :
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or gamma-glutamyl transferase (GGT) exceeding 2 times ULN, or total bilirubin exceeding 1.5 times ULN
• Creatine kinase (CK) exceeding 3 times the upper limit of normal (ULN)
• General:
• History of drug or substance abuse;
• Average of 5 or more cigarettes per day during the 4 weeks prior to screening;
• 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;
• Vaccination within 2 weeks prior to screening or planned during the course of the trial
• 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.

Sponsors & Collaborators

• Beijing Suncadia Pharmaceuticals Co., Ltd: lead

Study Sites (1)

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 511447, China

Location

Related Publications (1)

• 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.

  PMID: 40576753 DERIVED

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SHR-1918 injection compared with placebo

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: June 27, 2022
• Study Start: June 27, 2022
• Primary Completion: December 11, 2023
• Study Completion: December 12, 2023
• Last Updated: July 6, 2023

Record last verified: 2023-07

Locations

CN (1)