NCT04516564

A Study of AK119 (Anti-CD73 Antibody), a Treatment for COVID-19, in Healthy Subjects

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, First-In-Human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of AK119 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Akesobio Australia Pty Ltd · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a first-in-human (FIH), Phase 1, single-center, randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, PK and immunogenicity of AK119, a humanized monoclonal antibody targeting the CD73. The study will consist of 4 cohorts of healthy subjects. Eight subjects will be enrolled per cohort, randomized in a 3:1 ratio to receive a single dose of either the active drug AK119 (N=6) or matching placebo (N=2). Approximately 32 subjects (24 receiving active drug and 8 receiving placebo) will participate in this study.

Conditions

• Coronavirus Disease 2019 (COVID-19)

Interventions

Type	Name	Description
DRUG	AK119	Single dose of AK119 is administered via intravenous infusion to healthy subjects
DRUG	Placebo	Single dose of placebo is administered via intravenous infusion to healthy subjects

Timeline

• Start date: 2020-09-28
• Primary completion: 2021-05-04
• Completion: 2021-06-21
• First posted: 2020-08-18
• Last updated: 2025-02-28

Locations

1 site across 1 country: New Zealand