drugset / Trial / NCT05914909

Safety, Tolerability, PK and PD Study of AD-214 Administered to Healthy Volunteers and Patients With Interstitial Lung Disease or Chronic Kidney Disease

NCT05914909

Phase 1 Completed 8 enrolled AdAlta Limited
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a Phase I, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of a 10 mg/kg dose of AD-214 when administered to healthy volunteers (HVs) (Part A) or patients with interstitial lung disease (ILD) or chronic kidney disease (CKD) (Part B). The study will be performed in Australia at up to two clinical sites.

Timeline

Start
2023-07-17
Primary completion
2024-02-09
Completion
2024-02-09

Drugs

EvaluationDrugModalityDoseRoute
Subject AD-214 Protein / enzyme biologic 10 mg/kg Intravenous