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WAL0921 for Healthy Subjects
Phase 1
Waitlist Available
Research Sponsored by Walden Biosciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to day 64
Awards & highlights
Study Summary
This trial tests a new drug's safety, how it moves in the body and how it affects the body in healthy people.
Who is the study for?
This trial is for healthy adults between the ages of 18 and 65 with a BMI between 18 and 32 kg/m2. Participants should not have any known current or chronic medical conditions.Check my eligibility
What is being tested?
The study is testing WAL0921, a new drug, against a placebo (a substance with no active drug). It's randomized and double-blind, meaning neither the researchers nor participants know who gets the real drug or placebo.See study design
What are the potential side effects?
Since this is an early-stage trial to assess safety, specific side effects are not yet known but will be closely monitored throughout the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 to day 64
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 64
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of treatment emergent adverse events
Secondary outcome measures
AUC
Cmax
Half-life
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: WAL0921Experimental Treatment1 Intervention
Single intravenous infusion of investigational drug WAL0921
Group II: PlaceboPlacebo Group1 Intervention
Single intravenous infusion of normal saline
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
WAL0921
2023
Completed Phase 1
~40
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Walden BiosciencesLead Sponsor
Andrew Blair, MDStudy DirectorWalden Biosciences, Inc.
Peter Linde, MDStudy DirectorWalden Biosciences, Inc.
1 Previous Clinical Trials
36 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: WAL0921
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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