Safety and Tolerability of SHR-1918 in Healthy Subjects

Phase 1

Active, not recruiting

• Conditions: Hyperlipemia
• Interventions: Drug: SHR-1918; Drug: SHR-1918 placebo

• Registration Number: NCT05432544
• Lead Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-21
• Study First Submitted QC: 2022-06-24
• Study Start: 2022-06-27
• Study First Posted: 2022-06-27
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-03
• Last Update Posted: 2023-07-06
• Primary Completion: 2023-12-11
• Study Completion: 2023-12-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SAD, SHR-1918	SHR-1918	Up to 6 cohorts of healthy subjects will receive a single dose of SHR-1918 injection
SAD, SHR-1918 placebo	SHR-1918 placebo	Up to 6 cohorts of healthy subjects will receive a single dose of SHR-1918 placebo injection

Primary Outcome Measures

Name	Time	Method
To assess the number of subjects with serious adverse events (SAEs)	up to day 190
To assess the number of subjects with adverse events (AEs)	up to day 190

Secondary Outcome Measures

Name	Time	Method
To assess VLDL-C.	up to day 190
To assess ADA(or/and Nab).	up to day 190
To assess Tmax	up to day 190
To assess HDL-C	up to day 190
To assess CL/F	up to day 190
To assess TG	up to day 190
To assess ApoB	up to day 190
To assess AUC0-t	up to day 190
To assess t1/2	up to day 190
To assess 、V/F.	up to day 190
To assess LDL-C	up to day 190
To assess ApoA1	up to day 190
To assess AUC0-∞	up to day 190
To assess Cmax	up to day 190
To assess TC	up to day 190
To assess Lp(a)	up to day 190

Trial Locations

Locations (1)

The Second Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China