Single Ascending Dose Study of WAL0921 in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: WAL0921

• Registration Number: NCT05891366
• Lead Sponsor: Walden Biosciences

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-20
• Study Start: 2023-05-31
• Study First Submitted QC: 2023-06-05
• Study First Posted: 2023-06-06
• Primary Completion: 2024-01-09
• Study Completion: 2024-01-09
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-08
• Last Update Posted: 2024-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Single intravenous infusion of normal saline
WAL0921	WAL0921	Single intravenous infusion of investigational drug WAL0921

Primary Outcome Measures

Name	Time	Method
Incidence of treatment emergent adverse events	Day 1 to Day 64

Secondary Outcome Measures

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

Trial Locations

Locations (1)

PPD Pharmacology Unit; 🇺🇸 Austin, Texas, United States