Status:
ENROLLING_BY_INVITATION
A Study on Evaluating the Safety of HST101 in Healthy Chinese Participants
Lead Sponsor:
Hasten Biopharmaceutical Co., Ltd.
Conditions:
Hypercholesterolemia
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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...
Detailed Description
The planned 30 study participants will be assigned to low- or high-dose 2 cohorts and 15 participants in each cohort will be randomized to either the HST101 group or the matching dose placebo group an...
Eligibility Criteria
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
- 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.
Key Trial Info
Start Date :
September 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06504043
Start Date
September 17 2024
End Date
March 31 2025
Last Update
March 14 2025
Active Locations (1)
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1
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610044