Single, Ascending Dose Study of WAL0921 in Healthy Subjects

• Sponsor: Walden Biosciences (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05891366
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 8.1
• Patients Per Site Per Month: 4.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: WAL0921; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Safety, Pharmacokinetics, and Pharmacodynamics of a Single, Ascending Dose of WAL0921 in Healthy Subjects
• Actual Study Start Date: May 31, 2023
• Anticipated Primary Completion Date: Jan 1, 2024
• Anticipated Study Completion Date: Feb 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Incidence of treatment emergent adverse events [Day 1 to Day 64]

Secondary Outcome Measures

1. Number of participants with clinically significant changes in hematology lab values [Day 64]

   Hematology labs include complete blood count with differential and coagulation panel

2. Number of participants with clinically significant changes in chemistry lab values [Day 64]

   Chemistry labs include a comprehensive metabolic panel

3. AUC [Day 1 to Day 64]

   Area Under the Drug Concentration-Time Curve

4. Cmax [Day 1 to Day 64]

   Maximum Observed Drug Concentration

5. Half-life [Day 1 to Day 64]

   Drug terminal elimination half-life

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

1. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PPD Pharmacology Unit	Austin	Texas	United States	78744

Sponsors and Collaborators

• Walden Biosciences

Investigators

• Study Director: Peter Linde, MD, Walden Biosciences, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Walden Biosciences
• ClinicalTrials.gov Identifier: NCT05891366
• Other Study ID Numbers: WAL0921-01
• First Posted: Jun 6, 2023
• Last Update Posted: Jun 6, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jun 6, 2023