What side effects are associated with this type of intervention?

Common treatments for inflammatory pain, such as NSAIDs (e.g., ibuprofen, naproxen), are associated with several side effects. These include gastrointestinal issues like bleeding and ulcers, renal impairment, and cardiovascular risks such as myocardial infarction and stroke. The severity and incidence of these side effects can vary between different NSAIDs, with some like ibuprofen generally having a lower toxicity profile compared to others. It is crucial to monitor patients closely, especially those with pre-existing conditions that may exacerbate these risks.

What prior FDA approvals exist?

The FDA has approved several NSAIDs for the treatment of inflammatory pain, including celecoxib, a COX-2 selective inhibitor, which has been used for conditions like osteoarthritis and rheumatoid arthritis. Celecoxib was approved based on its efficacy in reducing pain and inflammation with a relatively favorable gastrointestinal safety profile compared to non-selective NSAIDs. Other NSAIDs like naproxen and ibuprofen have also been approved for similar indications. Additionally, newer investigational drugs like tanezumab, an anti-NGF monoclonal antibody, showed promise in reducing pain but faced safety concerns, leading to halted development. These approvals and studies highlight the ongoing efforts to balance efficacy and safety in the treatment of inflammatory pain.

What other types of research exist?

Promising novel alternatives to AFA-281 for inflammatory pain include FS 205-397, which mimics the antipyretic/analgesic profile of paracetamol without causing hepatotoxicity or gastric lesions. Additionally, Fortagesic has shown effectiveness with fewer side effects compared to Paramol 118 in osteoarthritis patients. Both options offer potential benefits in terms of safety and tolerability.

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AFA-281 Safety Study in Healthy Volunteers

Phase 1

Recruiting

Research Sponsored by Afasci Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must be in good general health with no significant medical history and have no clinically significant abnormalities on physical examination at screening and/or before administration of the initial dose of study drug.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 72 hours after dose

Summary

This trial tests a new drug, AFA-281, in healthy volunteers to check its safety and how it behaves in the body. Volunteers take the drug for a short period. Researchers measure drug levels in the blood and monitor for any side effects.

Who is the study for?

This trial is for healthy volunteers with a BMI between 18.0 and 30.0, no significant medical history, normal lab values, and a normal ECG. People with any significant health issues or abnormal test results cannot participate.

What is being tested?

The study tests AFA-281 in two parts: Part 1 gives single doses to groups of volunteers to check safety and how the body processes the drug. If safe, Part 2 has them take it for 14 days to further assess these factors.

What are the potential side effects?

Since this is an early-phase trial for AFA-281, potential side effects are being investigated; however, common side effects may include reactions at the dosing site, gastrointestinal discomforts like nausea or diarrhea, headaches or dizziness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am in good health with no major medical issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ predose and up to 72 hours after dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~predose and up to 72 hours after dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and predose and up to 72 hours after dose for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Area under the plasma concentration versus time curve (AUC) of the study drug

Blood Pressure

Blood chemistry

+9 more

Secondary study objectives

A dose and exposure relationship

Area under the plasma concentration versus time curve (AUC) of the major metabolite in blood

Plasma Concentration (Cmax) of the major metabolite in blood

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: AFA-281Experimental Treatment1 Intervention

Part 1: AFA-281 administered as an oral capsule at 5 dose levels for one day. Part 2: AFA-281 administered as an oral capsule at 3 dose levels twice daily for 14 consecutive days. Doses will be determined after completion of Part 1.

Group II: Placebo ControlPlacebo Group1 Intervention

Double blind placebo control

0 / 1Eligibility criteria met

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

Common treatments for inflammatory pain include NSAIDs, corticosteroids, and biologics. NSAIDs work by inhibiting cyclooxygenase (COX) enzymes, reducing the production of pro-inflammatory prostaglandins, which helps alleviate pain and inflammation. Corticosteroids suppress the immune response by inhibiting multiple inflammatory pathways, including cytokine production. Biologics, such as anti-TNF agents, target specific components of the immune system to reduce inflammation. Understanding these mechanisms is crucial for patients as it helps tailor treatments to their specific inflammatory conditions, potentially improving efficacy and minimizing side effects. The trial AFA-281 focuses on evaluating the safety, tolerability, and pharmacokinetics of a new treatment, which is essential for ensuring that new therapies provide effective pain relief with manageable side effects.

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