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

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug called WAL0921 in healthy people to see if it is safe and understand how it moves through and affects the body.

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.

What safety data exists for WAL0921 in healthy subjects?

There is general safety data from phase I studies involving healthy volunteers, which show that adverse events (unwanted effects from the treatment) can occur, but the frequency and seriousness vary. These studies help understand the safety of treatments like WAL0921, even if they were tested under different names or for other conditions. ^{1 2 3 4 5}

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]

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]

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]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Quantifying the risks of non-oncology phase I research in healthy volunteers: meta-analysis of phase I studies. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Strategies for safety reporting in substance abuse trials. [2013]

3. Germany pubmed.ncbi.nlm.nih.gov

Adverse events in phase-I studies: a report in 1015 healthy volunteers. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

ADVERPred-Web Service for Prediction of Adverse Effects of Drugs. [2018]

5. England pubmed.ncbi.nlm.nih.gov

A curated and standardized adverse drug event resource to accelerate drug safety research. [2020]