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Enrolling by invitation NCT06504043

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

Phase I Interventional Hypercholesterolemia Healthy Volunteers LDL-Cholesterol

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HST101.
Who it may be relevant to
Registry conditions: Hypercholesterolemia, Healthy Volunteers, LDL-Cholesterol. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

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

Primary outcome measures

  • 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) [Time frame: 57 days]
Secondary outcome measures (7)
  • To assess the pharmacokinetic characteristics and dose proportionality relathionship of HST101 following a single SC dose [Time frame: 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 [Time frame: 57 days]
  • To assess the effect of a single SC dose of HST101 on blood lipids including TC, HDL-C, VLDL-C, and TG [Time frame: 57 days]
  • To assess the effect of a single SC dose of HST101 on serum ApoB, Apo A1 concentrations [Time frame: 57 days]
  • To assess the effect of a single SC dose of HST101 on serum Lp(a) concentrations [Time frame: 57 days]
  • To assess the PK-PD relationship following a single SC dose of HST101 [Time frame: 57 days]
  • To assess immunogenicity (incidence, titer, and duration of ADAs/NAbs) following a single SC dose of HST101 [Time frame: 57 days]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Triple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • West China Hospital of Sichuan University — Chengdu

Identifiers

NCT: NCT06504043 · HST101-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗