NCT05891366
Completed
Phase 1
Safety, Pharmacokinetics, and Pharmacodynamics of a Single, Ascending Dose of WAL0921 in Healthy Subjects
Walden Biosciences1 site in 1 country40 target enrollmentStarted: May 31, 2023Last updated:
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Walden Biosciences
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Incidence of treatment emergent adverse events
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
WAL0921
Experimental
Single intravenous infusion of investigational drug WAL0921
Intervention: WAL0921 (Drug)
Placebo
Placebo Comparator
Single intravenous infusion of normal saline
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Incidence of treatment emergent adverse events
Time Frame: Day 1 to Day 64
Secondary Outcomes
- Half-life(Day 1 to Day 64)
- Cmax(Day 1 to Day 64)
- Number of participants with clinically significant changes in chemistry lab values(Day 64)
- AUC(Day 1 to Day 64)
- Number of participants with clinically significant changes in hematology lab values(Day 64)
Investigators
Study Sites (1)
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