NCT04829123

The Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of HEC88473 in Healthy Subjects

A Phase 1, Double Blind, Placebo Controlled, Single and Multiple Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of HEC88473 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Dongguan HEC Biopharmaceutical R&D Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

A Phase 1, double blind, placebo controlled, single and multiple ascending dose, safety, tolerability, pharmacokinetic, and pharmacodynamic study of HEC88473 in healthy subjects

Detailed description

This is the first time HEC88473 will be administered to humans. The aim of this study is to obtain safety, tolerability, PK, PD, and immunogenicity data of HEC88473 SC administration as single and multiple ascending doses in healthy subjects.

Conditions

• Non-alcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	HEC88473 injection	HEC88473 will be provided as a 17 mg/mL solution and will be administered by subcutaneous injection in the abdomen
DRUG	Placebo	Placebo will be administered by subcutaneous injection in the abdomen

Timeline

• Start date: 2021-05-14
• Primary completion: 2022-03-02
• Completion: 2022-03-02
• First posted: 2021-04-02
• Last updated: 2023-02-15

Locations

1 site across 1 country: Australia