Single, Ascending Dose Study of WAL0921 in Healthy Subjects

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

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: WAL0921
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults, age ≥ 18 and ≤ 65 years at the time of anticipated dosing Healthy individuals without known current or chronic medical conditions in the opinion of the Investigator Body mass index (BMI) ≥ 18 and ≤ 32 kg/m2 Exclusion Criteria: 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 Renal function calculated by the CKD-EPI (2021) equation with eGFR <90 mL/min/1.73 m2 at the time of screening Abnormal levels of proteinuria detected on Urine Protein-Creatinine Ratio (UPCR) test >0.30 g/g 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WAL0921<br>Single intravenous infusion of investigational drug WAL0921 | Drug: WAL0921<br>* Investigational product WAL0921<br>|
| Placebo Comparator: Placebo<br>Single intravenous infusion of normal saline | Drug: Placebo<br>* Placebo product<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment emergent adverse events |  | Day 1 to Day 64 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with clinically significant changes in hematology lab values | Hematology labs include complete blood count with differential and coagulation panel | Day 64 | 
| Number of participants with clinically significant changes in chemistry lab values | Chemistry labs include a comprehensive metabolic panel | Day 64 | 
| AUC | Area Under the Drug Concentration-Time Curve | Day 1 to Day 64 | 
| Cmax | Maximum Observed Drug Concentration | Day 1 to Day 64 | 
| Half-life | Drug terminal elimination half-life | Day 1 to Day 64 |