NCT06504043

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

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

• Status: Enrolling By Invitation
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Hasten Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hypercholesterolemia
• Healthy Volunteers
• LDL-Cholesterol

Interventions

Type	Name	Description
DRUG	HST101	HST101 is a novel anti-PCSK9 fusion protein

Timeline

• Start date: 2024-09-17
• Primary completion: 2025-01-08
• Completion: 2025-03-31
• First posted: 2024-07-16
• Last updated: 2025-03-14

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study