NCT05414734

Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic Characteristics of HHT120 in Healthy Subjects

A Single and Multiple Assending Doses Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamic Characteristics and Food Effect After Administration of HHT120 Capsule in Healthy Subjects

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Shanghai Synergy Pharmaceutical Sciences Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a first in human clinical trial with HHT120. The purpose of this study is to characterize the safety, pharmacokinetic (PK) and Pharmacodynamic (PD) profile of single and multiple twice-daily doses of HHT120 in healthy Subjects and to assess the effects of food on the PK profile of single-dose of HHT120 in healthy Subjects.

Detailed description

There are 3 parts of the study: Part 1: Single asending dose trial; Part 2: Multiple asending dose trial; Part 3: Food effect trial ( 2-Period Crossover)

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	HHT120	Capsule, oral administration
DRUG	Placebo	Capsule, oral administration

Timeline

• Start date: 2022-07-01
• Primary completion: 2023-02-15
• Completion: 2023-03-01
• First posted: 2022-06-10
• Last updated: 2023-02-01

Locations

1 site across 1 country: China