HST101: HST101 is a novel anti-PCSK9 fusion protein
Study summary
This is a single-center, randomized, double-blind, placebo-controlled, single HST101 SC dose cohort study to evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Chinese Participants with Elevated LDL-C Levels.
Eligibility
Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* Men and women who are ≥18 and ≤55 years of age with elevated LDL-C Levels;
* LDL-C ≥ 2.6 mmol/L (100 mg/dL) and ≤ 4.9 mmol/L (190 mg/dL) and TG ≤ 2.83 mmol/L (250 mg/dL) who are not on a lipid-lowering therapy 30 days prior to screening;
* Body mass index (BMI) ≥18 and≤28 kg/m2
Exclusion Criteria:
* Positive blood screen for HIV antibody, Treponema pallidum antibody, HBsAg or HCV antibody;
* Clinically significant liver function test abnormalities at screening, such as AST or ALT \> 2 × ULN, total bilirubin \> 1.5 × ULN, or ALP \> 2 × ULN based on normal values;
* CK \> 3 × ULN at the screening visit, it can be retested if considered to be related to exercise;
* History of prescription drug abuse, illicit drug use or alcohol abuse;
* Use of any prescription drug, herbal and compound decoction, vitamins, minerals, and OTC drugs and nutritional supplements that alter lipid metabolism within 14 days prior to Check-in and planned use of the above drugs throughout the study;
* Prior treatment with PCSK9 inhibitors, including mAbs, siRNA products, or any Adnectin products;
* History of allergy to protein-based biologics including, but not limited to, mAbs and vaccine;
* Less than 30 days or less than 5 half-lives (drug) since the end of participation in another clinical trial (drug or device), whichever is longer;
* Use of any other biologics within 3 months prior to investigational product administration;
* Any other significant clinical diseases or psychological diseases that the investigator considers to be inappropriate for participation in this study.
Primary outcome measure(s)
The primary objective of this study is to assess the safety and tolerability of a single SC dose of HST101 in Chinese healthy adult study participants with elevated LDL-C level(International Standard Unit: mmol/L) — 57 days Safety and tolerability will be assessed by the incidence and severity of treatment emergent adverse events
Trial sites (1)
Facility
City
Region
Status
West China Hospital of Sichuan University
Chengdu
Sichuan
More Hasten Biopharmaceutical Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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