Safety and Tolerability of SHR-1918 in Healthy Subjects

Hyperlipemia Clinical Trial

Official title:

A Phase 1, Randomized, Double Blind, Dose-escalation, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Subcutaneous Injection of SHR-1918 Injection in Healthy Subjects

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05432544
• Other study ID #: SHR-1918-101
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: June 27, 2022
• Est. completion date: December 12, 2023

Study information

• Verified date: July 2023
• Source: Beijing Suncadia Pharmaceuticals Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 72
• Est. completion date: December 12, 2023
• Est. primary completion date: December 11, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperlipemia
• Hyperlipidemias

Intervention

Drug:
• SHR-1918
Ascending dose
• SHR-1918 placebo
Ascending dose

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Suncadia Pharmaceuticals Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the number of subjects with adverse events (AEs)		up to day 190
Primary	To assess the number of subjects with serious adverse events (SAEs)		up to day 190
Secondary	To assess AUC0-t		up to day 190
Secondary	To assess AUC0-8		up to day 190
Secondary	To assess Tmax		up to day 190
Secondary	To assess Cmax		up to day 190
Secondary	To assess t1/2		up to day 190
Secondary	To assess CL/F		up to day 190
Secondary	To assess ?V/F.		up to day 190
Secondary	To assess LDL-C		up to day 190
Secondary	To assess TC		up to day 190
Secondary	To assess HDL-C		up to day 190
Secondary	To assess TG		up to day 190
Secondary	To assess ApoB		up to day 190
Secondary	To assess ApoA1		up to day 190
Secondary	To assess Lp(a)		up to day 190
Secondary	To assess VLDL-C.		up to day 190
Secondary	To assess ADA(or/and Nab).		up to day 190