Clinical trial NCT06504043: A Study on Evaluating the Safety of HST101 in Healthy Chinese Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
Conditions: Hypercholesterolemia
Healthy Volunteers
LDL-Cholesterol
Lead sponsor: Hasten Biopharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-07-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: the initially enrolled 15 subjects will receive low-dose single SC administration, followed by another 15 subjects will receive high-dose single SC administration.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 outcomes:
measure: 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)
timeFrame: 57 days
Secondary outcomes:
measure: To assess the pharmacokinetic characteristics and dose proportionality relathionship of HST101 following a single SC dose
timeFrame: 57 days
measure: To assess the PD effect of a single SC dose of HST101 on serum unbound (free) PCSK9 concentrations and serum LDL-C concentrations
timeFrame: 57 days
measure: To assess the effect of a single SC dose of HST101 on blood lipids including TC, HDL-C, VLDL-C, and TG
timeFrame: 57 days
measure: To assess the effect of a single SC dose of HST101 on serum ApoB, Apo A1 concentrations
timeFrame: 57 days
measure: To assess the effect of a single SC dose of HST101 on serum Lp(a) concentrations
timeFrame: 57 days
measure: To assess the PK-PD relationship following a single SC dose of HST101
timeFrame: 57 days
measure: To assess immunogenicity (incidence, titer, and duration of ADAs/NAbs) following a single SC dose of HST101
timeFrame: 57 days
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
References: