Single Ascending Dose Study of WAL0921 in Healthy Subjects

NCT05891366 | Completed Phase 1 FDA Drug

• 1 other identifier: WAL0921-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment emergent adverse events

  Day 1 to Day 64

Secondary Outcomes (5)

• Number of participants with clinically significant changes in hematology lab values

  Day 64

• Number of participants with clinically significant changes in chemistry lab values

  Day 64

• AUC

  Day 1 to Day 64

• Cmax

  Day 1 to Day 64

• Half-life

  Day 1 to Day 64

Study Arms (2)

WAL0921

EXPERIMENTAL

Single intravenous infusion of investigational drug WAL0921

Drug: WAL0921

Placebo

PLACEBO COMPARATOR

Single intravenous infusion of normal saline

Drug: Placebo

Interventions

WAL0921 DRUG

Investigational product WAL0921

WAL0921

Placebo DRUG

Placebo product

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Walden Biosciences: lead

Study Sites (1)

PPD Pharmacology Unit

Austin, Texas, 78744, United States

Location

Study Officials

• Andrew Blair, MD

  Walden Biosciences, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2023
• First Posted: June 6, 2023
• Study Start: May 31, 2023
• Primary Completion: January 9, 2024
• Study Completion: January 9, 2024
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)