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

NCT06504043 | Enrolling By Invitation Phase 1 FDA Drug

• 1 other identifier: HST101-101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypercholesterolemia; Healthy Volunteers; LDL-Cholesterol

Outcome Measures

Primary Outcomes (1)

• 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)

  Safety and tolerability will be assessed by the incidence and severity of treatment emergent adverse events

  57 days

Secondary Outcomes (7)

• To assess the pharmacokinetic characteristics and dose proportionality relathionship of HST101 following a single SC dose

  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

  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

• To assess the effect of a single SC dose of HST101 on serum ApoB, Apo A1 concentrations

  57 days

• To assess the effect of a single SC dose of HST101 on serum Lp(a) concentrations

  57 days

Study Arms (2)

Experimental: cohort low dose HST101

EXPERIMENTAL

HST101 single SC administration of 150 mg or placebo;

Drug: HST101

Experimental: cohort high dose HST101

EXPERIMENTAL

HST101 single SC administration of 300 mg or placebo.

Drug: HST101

Interventions

HST101 DRUG

HST101 is a novel anti-PCSK9 fusion protein

Also known as: Lerodalcibep

Experimental: cohort high dose HST101; Experimental: cohort low dose HST101

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hasten Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610044, China

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: the initially enrolled 15 subjects will receive low-dose single SC administration, followed by another 15 subjects will receive high-dose single SC administration.

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 16, 2024
• Study Start: September 17, 2024
• Primary Completion: January 8, 2025
• Study Completion: March 31, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)