A Study on Evaluating the Safety of HST101 in Healthy Chinese Participants
- Registration Number
- NCT06504043
- Lead Sponsor
- Hasten Biopharmaceutical Co., Ltd.
- 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 Participants with Elevated LDL-C Levels.
- 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 and will be administered in subsequent or in-parallel manner. Cohort 1: 15 study participants will receive the low dose of HST101 or placebo at a corresponding dose. Cohort 2: additional 15 study participants will receive the high dose of HST101 or placebo at a corresponding dose.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 30
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Experimental: cohort low dose HST101 HST101 HST101 single SC administration of 150 mg or placebo; Experimental: cohort high dose HST101 HST101 HST101 single SC administration of 300 mg or placebo.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method To assess the pharmacokinetic characteristics and dose proportionality relathionship of HST101 following a single SC dose 57 days The PK parameters include Cmax, Tmax, T1/2, AUC0-t, AUCinf and others if necessary
To assess the PD effect of a single SC dose of HST101 on serum unbound (free) PCSK9 concentrations and serum LDL-C concentrations 57 days Serum free PCSK9 and LDL-C will be measured at baseline and various time points over 57 days
To assess the effect of a single SC dose of HST101 on blood lipids including TC, HDL-C, VLDL-C, and TG 57 days Serum TC,HDL-C,VLDL-C and TG（ISU:mmol/L）will be measured at baseline and various time points over 57 days to assess percent change from baseline over time
To assess the effect of a single SC dose of HST101 on serum ApoB, Apo A1 concentrations 57 days Serum Apo B(ISU:mg/dL) , Apo A1(ISU:mg/dL) concentrations will be measured at baseline and various time points over 57 days to assess percent change from baseline over time
To assess the effect of a single SC dose of HST101 on serum Lp(a) concentrations 57 days Serum Lp (a)(ISU: nmol/L) concentrations will be measured at baseline and various time points over 57 days to assess percent change from baseline over time
To assess the PK-PD relationship following a single SC dose of HST101 57 days The PK-PD relationship will be measured over 57 days
To assess immunogenicity (incidence, titer, and duration of ADAs/NAbs) following a single SC dose of HST101 57 days Measurement of ADAs/NAbs will be done at baseline and various intervals after HST101 administration
Trial Locations
- Locations (1)
West China Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China