A Study on Evaluating the Safety of HST101 in Healthy Chinese Participants

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат HST101
  HST101 is a novel anti-PCSK9 fusion protein

Первичные конечные точки

• 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) [Срок оценки: 57 days]

Вторичные конечные точки (7)

• To assess the pharmacokinetic characteristics and dose proportionality relathionship of HST101 following a single SC dose [Срок оценки: 57 days]
• To assess the PD effect of a single SC dose of HST101 on serum unbound (free) PCSK9 concentrations and serum LDL-C concentrations [Срок оценки: 57 days]
• To assess the effect of a single SC dose of HST101 on blood lipids including TC, HDL-C, VLDL-C, and TG [Срок оценки: 57 days]
• To assess the effect of a single SC dose of HST101 on serum ApoB, Apo A1 concentrations [Срок оценки: 57 days]
• To assess the effect of a single SC dose of HST101 on serum Lp(a) concentrations [Срок оценки: 57 days]
• To assess the PK-PD relationship following a single SC dose of HST101 [Срок оценки: 57 days]
• To assess immunogenicity (incidence, titer, and duration of ADAs/NAbs) following a single SC dose of HST101 [Срок оценки: 57 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• West China Hospital of Sichuan University — Чэнду

Идентификаторы

NCT: NCT06504043 · HST101-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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