Safety and Tolerability of SHR-1918 in Healthy Subjects

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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05432544

Enrollment

Registered

2022-06-27

Start date

2022-06-27

Completion date

2023-12-12

Last updated

2023-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipemia

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.

Interventions

DRUGSHR-1918

Ascending dose

DRUGSHR-1918 placebo

Ascending dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

SHR-1918 injection compared with placebo

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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
To assess CL/F	up to day 190
To assess 、V/F.	up to day 190
To assess LDL-C	up to day 190
To assess TC	up to day 190
To assess HDL-C	up to day 190
To assess TG	up to day 190
To assess ApoB	up to day 190
To assess ApoA1	up to day 190
To assess Lp(a)	up to day 190
To assess VLDL-C.	up to day 190
To assess ADA(or/and Nab).	up to day 190
To assess AUC0-t	up to day 190

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026