NCT04540770

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: HuniLife Biotechnology, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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)

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	HuL001	Anti-ENO1 monoclonal antibody

Timeline

• Start date: 2021-08-31
• Primary completion: 2022-03-04
• Completion: 2024-01-19
• First posted: 2020-09-07
• Last updated: 2025-09-24

Locations

2 sites across 1 country: Taiwan

Regulatory

• FDA-regulated drug study