NCT06210607

A Trial of HS-10511 in Healthy Subjects

A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of HS-10511 in Healthy Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study is a phase I, randomized, double-blind, placebo-controlled clinical trial evaluating the safety, tolerability, and pharmacodynamic (PK) and pharmacodynamic (PD) characteristics of HS-10511 when administered as single oral dose and multiple oral doses in healthy adult subjects.

Detailed description

This study is a phase I, randomized, double-blind, placebo-controlled clinical trial evaluating the safety, tolerability, and PK and PD characteristics of HS-10511 in healthy adult subjects. This study consists of two parts: Part 1 is a single ascending dose (SAD) peroid in healthy subjects and Part 2 is a multiple ascending dose (MAD) period. Each period is composed of the screening, baseline, dosing and observation, and follow-up periods. All subjects will sign a written informed consent form (ICF) and will be assessed for eligibility criteria before entering the screening period (D-28-D-1). Subjects who meet all inclusion criteria and none of the exclusion criteria will be admitted in the baseline period (i.e., 1 day before dosing, D-1), undergo baseline assessment and randomization, complete dosing and the safety, tolerability, and PK and PD assessments within the given time period, and complete outpatient visits at the given follow-up time after discharge.

Conditions

• Hypertrophic Cardiomyopathy

Interventions

Type	Name	Description
DRUG	HS-10511 Tablets	HS-10511 tablets for 5\~6 SAD cohorts and 4 MAD cohorts
DRUG	HS-10511 Tablets Placebo	HS-10511 tablets placebo for 5\~6 SAD cohorts and 4 MAD cohorts

Timeline

• Start date: 2024-01-31
• Primary completion: 2024-06-30
• Completion: 2024-12-31
• First posted: 2024-01-18
• Last updated: 2024-01-18