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Completed

NCT Number: NCT05891366

Single Ascending Dose Study of WAL0921 in Healthy Subjects

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

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PPD Pharmacology Unit

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

WAL0921

Drug

Investigational product WAL0921

Placebo

Drug

Placebo product

Primary outcomes

  1. Incidence of treatment emergent adverse events

    Time frame: Day 1 to Day 64

Secondary outcomes

  1. Number of participants with clinically significant changes in hematology lab values

    Time frame: 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

    Time frame: Day 64

    Chemistry labs include a comprehensive metabolic panel

  3. AUC

    Time frame: Day 1 to Day 64

    Area Under the Drug Concentration-Time Curve

  4. Cmax

    Time frame: Day 1 to Day 64

    Maximum Observed Drug Concentration

  5. Half-life

    Time frame: Day 1 to Day 64

    Drug terminal elimination half-life

Sponsors and collaborators

Lead sponsor

Walden Biosciences

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 6, 2023
Registry last updated
Apr 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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