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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AD-214 | Protein / enzyme biologic | 10 mg/kg | Intravenous |