Single Ascending Dose Study of WAL0921 in Healthy Subjects

Walden Biosciences

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: WAL0921

Study type: Interventional

Funder types: Industry

Identifiers

NCT05891366

WAL0921-01

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

WAL0921

Experimental group

Description:

Single intravenous infusion of investigational drug WAL0921

Treatment:

Drug: WAL0921

Placebo

Placebo Comparator group

Description:

Single intravenous infusion of normal saline

Treatment:

Drug: Placebo