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A Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Immunogenicity of HuL001

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:
A Phase 1 Single and Multiple Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Immunogenicity of HuL001 in Healthy Volunteers and Idiopathic Pulmonary Fibrosis Subjects

Clinical Trial Summary

This is a first-in-human, two-part, Phase 1 study that will characterize the safety, tolerability, PK, and immunogenicity of HuL001.

Clinical Trial Description

This is a first-in-human, two-part, Phase 1 study that will characterize the safety, tolerability, PK, and immunogenicity of HuL001 after single ascending doses in healthy subjects followed by multiple doses in IPF subjects. The study will be conducted in 2 parts: - Part A will enroll 3 single ascending doses (SAD) cohorts in healthy subjects. (HuL001:Placebo=4:2) - Part B will enroll 1 multiple-dose cohort in IPF subjects. The proposed dose of HuL001 will be selected from the single-dose range of HuL001 evaluated in the healthy subjects of Part A. (HuL001=6) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04540770
Study type Interventional
Source HuniLife Biotechnology, Inc.
Contact Zoe Chan, MS
Phone 886226579668
Email zoechan@hunilife.com
Status Recruiting
Phase Phase 1
Start date August 31, 2021
Completion date December 31, 2023
View Details
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