WAL0921 for Healthy Subjects

Overseen By Clinical Operations Director

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Walden Biosciences

Disqualifiers: Cardiovascular, Renal, Hepatic, Pulmonary, others

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effects of a new drug called WAL0921 in healthy individuals. Participants will receive either a single infusion of WAL0921 or a placebo, a harmless substance used for comparison. This process will help researchers understand how WAL0921 behaves in the body and how the body responds to it. Individuals without chronic medical conditions and who do not take medications regularly may be suitable for this study. As a Phase 1 trial, participants will be among the first to receive this new treatment, contributing to vital research on its effects in people.

Will I have to stop taking my current medications?

The trial is for healthy individuals without current medical conditions, so participants likely should not be on any medications. The protocol does not specify, but it seems participants should not be taking regular medications.

Is there any evidence suggesting that WAL0921 is likely to be safe for humans?

Research shows that WAL0921 is generally safe and well-tolerated. Earlier studies found that participants experienced a reduction in free suPAR, a marker linked to kidney diseases, without serious side effects. Most reported side effects were mild. In similar early studies, about 63.7% of healthy participants experienced some side effects, with 85% of these being mild and not serious. This suggests that WAL0921 is likely safe for healthy individuals, though it's important to note that this information comes from early research. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about WAL0921 because it introduces a novel approach to treatment by being administered as a single intravenous infusion, which is different from the current standard oral or multiple-dose regimens. This investigational drug may offer a faster and potentially more effective delivery method for the active ingredient directly into the bloodstream. The unique mechanism of action of WAL0921 could provide benefits over existing options by potentially targeting different biological pathways. These features might lead to quicker onset of action and improved outcomes, sparking interest and optimism among researchers.

What evidence suggests that WAL0921 could be effective?

Research shows that WAL0921, which participants in this trial may receive, may help treat kidney diseases. One study found that it lowered levels of a protein called suPAR, linked to kidney damage. The study also showed that higher doses of WAL0921 improved its effectiveness. Additionally, patients tolerated it well, and it proved safe. These findings suggest that WAL0921 could be useful in managing kidney health issues. ^{1 3 6 7 8}

Who Is on the Research Team?

Andrew Blair, MD

Principal Investigator

Walden Biosciences, Inc.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Healthy individuals without known current or chronic medical conditions in the opinion of the Investigator Body mass index (BMI) ≥ 18 and ≤ 32 kg/m2

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intravenous infusion of WAL0921 or placebo

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment

64 days

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• WAL0921

Trial Overview 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.

How Is the Trial Designed?

Group I: WAL0921 Experimental Treatment 1 Intervention

Single intravenous infusion of investigational drug WAL0921

Group II: Placebo Placebo Group 1 Intervention

Single intravenous infusion of normal saline

Who Is Running the Clinical Trial?

Walden Biosciences

Lead Sponsor

Trials

2

Recruited

140+

Published Research Related to This Trial

In a meta-analysis of 11,028 healthy participants across 394 non-oncology phase I studies, 63.7% experienced adverse events, but 85% of these were classified as mild, indicating a relatively safe profile for the study drugs.

Only 0.31% of participants experienced serious adverse events, with no deaths or life-threatening incidents reported, suggesting that while adverse events are common, they are mostly not severe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantifying the risks of non-oncology phase I research in healthy volunteers: meta-analysis of phase I studies. Emanuel, EJ., Bedarida, G., Macci, K., et al.[2018]

The study presents a curated and standardized version of the FDA Adverse Event Reporting System (FAERS) data, which enhances the quality and usability of drug safety surveillance by removing duplicates and standardizing drug and outcome vocabularies.

This new resource will facilitate faster and more reliable drug safety research by providing pre-computed statistics and reducing the time needed for data management, ultimately improving the identification of adverse drug reactions (ADRs) post-marketing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A curated and standardized adverse drug event resource to accelerate drug safety research. Banda, JM., Evans, L., Vanguri, RS., et al.[2020]

A new standardized strategy for reporting adverse events (AEs) and serious adverse events (SAEs) in substance use disorder (SUD) clinical trials was developed, which aims to reduce the reporting burden while maintaining safety monitoring.

In a review of 17 SUD trials involving 6737 participants, the new strategy showed a significant reduction in irrelevant safety event reporting, leading to a more consistent safety assessment system tailored to the risks associated with specific trial interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies for safety reporting in substance abuse trials. Lindblad, R., Campanella, M., Styers, D., et al.[2013]

In a comprehensive review of 54 phase-I studies involving 1015 healthy volunteers over 10 years, the overall incidence of adverse events was found to be 12.8%, with a higher rate for active drugs (13.7%) compared to placebo (7.9%).

Most adverse events were minor, with only 3% classified as severe, and no deaths or life-threatening events reported, highlighting that while adverse events are common in phase-I trials, they are typically not serious.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in phase-I studies: a report in 1015 healthy volunteers. Sibille, M., Deigat, N., Janin, A., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06466135

Study of WAL0921 in Patients With Glomerular Kidney ... Subjects in this study will be randomized to receive the investigational drug WAL0921 or placebo as an intravenous infusion once every 2 weeks for 7 total ...

2. biospace.com biospace.com/press-releases/walden-biosciences-fully-enrolls-first-cohort-in-phase-2-basket-study-of-wal0921-in-chronic-kidney-diseases

Walden Biosciences Fully Enrolls First Cohort in Phase 2 ... It has completed initial dosing of all subjects in the first cohort of a Phase 2 basket study evaluating WAL0921 as a treatment for chronic kidney diseases.

3. synapse.patsnap.com synapse.patsnap.com/article/walden-biosciences-completes-enrollment-for-phase-2-study-of-wal0921-in-kidney-diseases

Walden Biosciences Completes Enrollment for Phase 2 ... The results demonstrated that WAL0921 was safe, well-tolerated, and effective in rapidly reducing free suPAR levels in a dose-dependent manner.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05891366

Single Ascending Dose Study of WAL0921 in Healthy ... Study Overview. This is a randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, pharmacokinetics, and ...

5. trial.medpath.com trial.medpath.com/news/b9049de09a9fc050/walden-biosciences-engages-former-fda-director-to-advance-wal0921-phase-2-trial-in-rare-kidney-diseases

Walden Biosciences Engages Former FDA Director to ... ... healthy subjects across five cohorts. Study data showed that WAL0921 was well-tolerated and demonstrated proof-of-biology through a rapid ...

6. biospace.com biospace.com/walden-biosciences-announces-positive-topline-data-from-phase-1-clinical-study-of-wal0921-in-development-for-treatment-of-kidney-diseases

Walden Biosciences Announces Positive Topline Data ... Data from the study showed that WAL0921 was safe, well-tolerated, and demonstrated proof-of-biology through a rapid, dose-dependent reduction in free suPAR ...

7. nephcure.org nephcure.org/trials/walden-wal0921-02-study-denver-co/

Walden WAL0921-02 Study Denver, CO Study Goal. The goal of Study WAL0921-02 is to evaluate the safety, efficacy, PK, and PD of WAL0921 in subjects with DN and rare glomerular ...

8. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-4-2023-55098

WAL0921 for Healthy Subjects · Info for Participants In a meta-analysis of 11,028 healthy participants across 394 non-oncology phase I studies, 63.7% experienced adverse events, but 85% of these were classified as ...