NCT04652297

Safety, Tolerability and Pharmacokinetics of Single and Multiple Oral Administration of HS-10356 in Healthy Volunteers

A Phase I, Randomized, Double-blind, Placebo-controlled Dose Escalation Trial to Assess the Safety Tolerability and Pharmacokinetics of Single and Multiple Oral Administration of HS-10356 in Healthy Volunteers

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to assess the safety and tolerability of single and multiple oral administration of HS-10356 in healthy volunteers.

Detailed description

This is a phase I, randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) clinical trial to assess the safety, tolerability, and pharmacokinetics of HS-10356 oral formulation in Chinese healthy adult volunteers. Approximately five sequential dose panels (single oral doses of 2,6,15,30,45mg HS-10356) will be evaluated in SAD. To protect the safety of volunteers, two sentinel volunteers were first enrolled in the first dose panel (2mg panel) and randomly assigned to HS-10356 or placebo in a 1:1 ratio. After the sentinel volunteers were given the dose for at least 24 hours and confirmed that they were safe, the remaining 6 volunteers were randomly assigned to HS-10356 or placebo in a ratio of 5:1. For the follow-up panels of SAD, volunteers were randomly assigned to either the experimental group or the placebo group (6 cases in HS-10356 and 2 cases in placebo) in a 3:1 ratio using block randomization method. Approximately three sequential dose panels (14 consecutive days for respectively daily oral doses of 6,15,30mg HS-10356, QD) will be evaluated in MAD. Volunteers were randomly assigned to either the experimental group or the placebo group (9 cases in the HS-10356 and 3 cases in the placebo) in a ratio of 3:1 using block randomization method. Each subject will receive only one regimen in this study. Safety data up to Day12 (±2) in SAD and up to Day25 (±2) in MAD will be reviewed prior to dose escalation. Cohorts of SAD and MAD will be added or removed depending on the assessment results of SRC.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	HS-10356	Single dose of HS-10356
DRUG	Placebo	Single dose of Placebo
DRUG	HS-10356	Multiple doses of HS-10356
DRUG	Placebo	Multiple doses of Placebo

Timeline

• Start date: 2020-12-01
• Primary completion: 2021-08-01
• Completion: 2021-08-01
• First posted: 2020-12-03
• Last updated: 2020-12-03

Locations

1 site across 1 country: China