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Unknown

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 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 64
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 64 for reporting.

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 more

Trial 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

Find a Location

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

WAL0921 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05891366 — Phase 1
Healthy Subjects Research Study Groups: WAL0921, Placebo
Healthy Subjects Clinical Trial 2023: WAL0921 Highlights & Side Effects. Trial Name: NCT05891366 — Phase 1
WAL0921 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05891366 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do individuals aged under seventy-five qualify for this experiment?

"The terms of entry state that individuals between the ages of 18 and 65 are eligible to participate. Alternatively, there are 55 trials specifically for applicants below 18 years old and 370 studies catering to those over 65."

Answered by AI

Who qualifies for participation in the clinical trial?

"This medical trial is open to healthy volunteers aged 18 - 65, and 40 participants are needed."

Answered by AI

Has the WAL0921 pharmaceutical been validated by the FDA?

"The potential safety of WAL0921 was judged a 1 since this is an early trial, with minimal clinical data pointing to its efficacy and security."

Answered by AI

Are there opportunities for individuals to join this investigation currently?

"According to current records from clinicaltrials.gov, this experiment is currently enrolling participants. The original post was published on May 31st 2023 and the most recent edit occurred June 5th of that same year."

Answered by AI

How many participants is this research accommodating?

"Indeed, clinicaltrials.gov information confirms that this medical investigation is currently enrolling patients. The trial was initially posted on May 31st 2023 and most recently modified on June 5th 2023. It requires 40 participants from a single location to complete the study."

Answered by AI

Who else is applying?

What site did they apply to?
PPD Pharmacology Unit
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
~22 spots leftby Apr 2025