Single Ascending Dose Study of WAL0921 in Healthy Subjects

Safety, Pharmacokinetics, and Pharmacodynamics of a Single, Ascending Dose of WAL0921 in Healthy Subjects

This is a randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, pharmacokinetics, and pharmacodynamics of WAL0921 in healthy subjects.

Inclusion Criteria:

1. Adults, age ≥ 18 and ≤ 65 years at the time of anticipated dosing
2. Healthy individuals without known current or chronic medical conditions in the opinion of the Investigator
3. Body mass index (BMI) ≥ 18 and ≤ 32 kg/m2

Exclusion Criteria:

1. Clinically significant findings in physical examination, vital signs (blood pressure, heart rate, and body temperature), ECG, and safety laboratory parameters at screening in the opinion of the Investigator
2. Renal function calculated by the CKD-EPI (2021) equation with eGFR <90 mL/min/1.73 m2 at the time of screening
3. Abnormal levels of proteinuria detected on Urine Protein-Creatinine Ratio (UPCR) test >0.30 g/g
4. Any disease or condition that, in the opinion of the Investigator, might significantly compromise the cardiovascular, hematological, renal, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central nervous, or gastrointestinal (including an ulcer) systems