Clinical trial NCT05432544: Safety and Tolerability of SHR-1918 in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Hyperlipemia
Lead sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd
Sponsor class: INDUSTRY
First posted: 2022-06-27
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: SHR-1918 injection compared with placebo
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: To assess the number of subjects with adverse events (AEs)
timeFrame: up to day 190
measure: To assess the number of subjects with serious adverse events (SAEs)
timeFrame: up to day 190
Secondary outcomes:
measure: To assess AUC0-t
timeFrame: up to day 190
measure: To assess AUC0-∞
timeFrame: up to day 190
measure: To assess Tmax
timeFrame: up to day 190
measure: To assess Cmax
timeFrame: up to day 190
measure: To assess t1/2
timeFrame: up to day 190
measure: To assess CL/F
timeFrame: up to day 190
measure: To assess 、V/F.
timeFrame: up to day 190
measure: To assess LDL-C
timeFrame: up to day 190
measure: To assess TC
timeFrame: up to day 190
measure: To assess HDL-C
timeFrame: up to day 190
measure: To assess TG
timeFrame: up to day 190
measure: To assess ApoB
timeFrame: up to day 190
measure: To assess ApoA1
timeFrame: up to day 190
measure: To assess Lp(a)
timeFrame: up to day 190
measure: To assess VLDL-C.
timeFrame: up to day 190
measure: To assess ADA(or/and Nab).
timeFrame: up to day 190
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
References: