Single Ascending Dose Study of WAL0921 in Healthy Subjects

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05891366
• Other study ID #: WAL0921-01
• Status: Completed
• Phase: Phase 1
• Start date: May 31, 2023
• Est. completion date: January 9, 2024

Study information

• Verified date: April 2024
• Source: Walden Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 9, 2024
• Est. primary completion date: January 9, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• WAL0921
Investigational product WAL0921
• Placebo
Placebo product

Locations

Country	Name	City	State
United States	PPD Pharmacology Unit	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Walden Biosciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment emergent adverse events		Day 1 to Day 64
Secondary	Number of participants with clinically significant changes in hematology lab values	Hematology labs include complete blood count with differential and coagulation panel	Day 64
Secondary	Number of participants with clinically significant changes in chemistry lab values	Chemistry labs include a comprehensive metabolic panel	Day 64
Secondary	AUC	Area Under the Drug Concentration-Time Curve	Day 1 to Day 64
Secondary	Cmax	Maximum Observed Drug Concentration	Day 1 to Day 64
Secondary	Half-life	Drug terminal elimination half-life	Day 1 to Day 64