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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: WAL0921; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78744
      • PPD Pharmacology Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WAL0921; Single intravenous infusion of investigational drug WAL0921	Drug: WAL0921; Investigational product WAL0921
Placebo Comparator: Placebo; Single intravenous infusion of normal saline	Drug: Placebo; Placebo product

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Walden Biosciences
• Investigators: Study Director: Andrew Blair, MD, Walden Biosciences, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2023
• Primary Completion (Actual): January 9, 2024
• Study Completion (Actual): January 9, 2024

Study Registration Dates

• First Submitted: May 20, 2023
• First Submitted That Met QC Criteria: June 5, 2023
• First Posted (Actual): June 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: WAL0921-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No