What is the mechanism of action of this treatment?

The most common treatments in healthy subjects are evaluated based on their pharmacokinetics and pharmacodynamics. Pharmacokinetics studies how a drug is absorbed, distributed, metabolized, and excreted by the body, while pharmacodynamics examines the drug's effects and mechanisms of action at the target site. These evaluations are crucial for ensuring the safety and efficacy of new treatments, as they help predict the drug's behavior in the body and potential side effects. This understanding is essential for developing safe and effective medications for broader patient populations.

What side effects are associated with this type of intervention?

In studies evaluating the safety, pharmacokinetics, and pharmacodynamics of treatments in healthy subjects, common side effects include nausea, injection-site reactions (such as burning or stinging), tingling sensations (paresthesia), dizziness, and fatigue. These adverse events are generally mild and transient.

What prior FDA approvals exist?

The FDA has approved various drugs following rigorous evaluations of their safety, pharmacokinetics, and pharmacodynamics in healthy subjects. These studies often involve single ascending dose trials, similar to the WAL0921 study, to determine the appropriate dosing and safety profile. Examples include antiviral agents like peramivir and zanamivir, which underwent phase I and II trials to assess their pharmacokinetics and safety before approval. Such trials are crucial for ensuring that new treatments are both effective and safe for broader patient populations.

What other types of research exist?

Promising novel alternatives to WAL0921 for healthy subjects in 2024 could include other investigational drugs undergoing similar early-phase clinical trials. For example, MYL-1401O, a trastuzumab biosimilar, has demonstrated similar pharmacokinetics and safety profiles to established treatments in phase 1 studies. Additionally, other new tyrosine kinase inhibitors or immunotherapies being evaluated in phase 1 trials for their safety and pharmacokinetics could also be considered as potential alternatives.

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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

Summary

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.

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.

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.

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

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments in healthy subjects are evaluated based on their pharmacokinetics and pharmacodynamics. Pharmacokinetics studies how a drug is absorbed, distributed, metabolized, and excreted by the body, while pharmacodynamics examines the drug's effects and mechanisms of action at the target site. These evaluations are crucial for ensuring the safety and efficacy of new treatments, as they help predict the drug's behavior in the body and potential side effects. This understanding is essential for developing safe and effective medications for broader patient populations.

Design and implementation of clinical trials in rehabilitation research.