Tests HST101 safety in healthy Chinese adults with high LDL cholesterol
Tests a single dose of HST101 against placebo in healthy adults with high cholesterol.
Plain-language title generated from the registry record
Registry title: A Study on Evaluating the Safety of HST101 in Healthy Chinese Participants
Key facts
- Where
- Chengdu, ChinaSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 55 years old?
Source: NCT06504043, who can take part
Where in China
- West China Hospital of Sichuan UniversityChengdu, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hasten Biopharmaceutical Co., Ltd.
- Trial code
- NCT06504043
- Record updated
- 14 March 2025
- Original description
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.Read full original descriptionShow less
A Randomized, Double-Blind, Placebo-Controlled, Single-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of HST101 in Healthy Chinese Study Participants With Elevated LDL-C Levels
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.
Inclusion: 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: 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; 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; Positive blood screen for HIV antibody, Treponema pallidum antibody, HBsAg or HCV antibody; History of prescription drug abuse, illicit drug use or alcohol abuse; History of allergy to protein-based biologics including, but not limited to, mAbs and vaccine; Any other significant clinical diseases or psychological diseases that the investigator considers to be inappropriate for participation in this study; 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.