What side effects are associated with this type of intervention?

Common treatments for atopic dermatitis include topical corticosteroids, calcineurin inhibitors (such as tacrolimus and pimecrolimus), and newer biologics like dupilumab. Topical corticosteroids can cause skin thinning, stretch marks, and systemic effects with prolonged use. Calcineurin inhibitors may lead to burning sensations and increased risk of skin infections. Dupilumab, administered subcutaneously, is generally well-tolerated but can cause injection site reactions, conjunctivitis, and nasopharyngitis. Other treatments like JAK inhibitors (e.g., abrocitinib) can cause nausea, headache, and increased risk of infections.

What prior FDA approvals exist?

Several treatments for atopic dermatitis have received FDA approval, including both topical and systemic therapies. Topical treatments like crisaborole ointment, 2%, and tacrolimus ointment have been approved for mild-to-moderate atopic dermatitis. Systemic treatments such as dupilumab, a biologic agent, have been approved for moderate-to-severe cases. Dupilumab has shown significant efficacy in achieving a reduction in the Eczema Area and Severity Index (EASI-75) score. Other systemic treatments include cyclosporine and methotrexate, which are used for severe refractory cases. These treatments have been evaluated in randomized, double-blind, placebo-controlled trials, similar to the study design for FB825.

What other types of research exist?

Promising novel alternatives to FB825 for Atopic Dermatitis patients include VTP-38543 cream, which has shown efficacy in a randomized controlled trial by improving SCORing of Atopic Dermatitis and other clinical assessments. Additionally, IL-17 inhibitors like ixekizumab and secukinumab, which have demonstrated efficacy in related conditions such as psoriasis, may also be considered for AD treatment.

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Monoclonal Antibodies

FB825 for Atopic Dermatitis

Phase 1

Waitlist Available

Research Sponsored by Oneness Biotech Co., Ltd.

Eligibility Criteria Checklist

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

Must have

Male or female, nonsmoker (no use of tobacco or nicotine products within 3 months prior to screening), ≥18 and ≤55 years of age, with body mass index (BMI) ≥18.5 and ≤30.0 kg/m2 and body weight ≥50.0 kg.

Female subjects of non-childbearing potential must be post-menopausal (spontaneous amenorrhea for at least 12 months prior to dosing) with follicle-stimulating hormone (FSH) levels per laboratory standard; or surgically sterile at least 3 months prior to dosing.

Must not have

The subject has received any immunoglobulin products or blood products within 6 months of Day -1 or has any previous participation in a clinical research study involving the administration of FB825.

Donation of plasma within 2 months prior to dosing or donation or loss of 500 mL or more of whole blood within 2 months prior to dosing.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Summary

This trial tests a new drug called FB825 in healthy adults to see if it is safe and to understand how it behaves in the body.

Who is the study for?

Healthy adults aged 18-55, non-smokers with a BMI of 18.5-30 and weight over 50 kg can join this trial. They must not have significant medical conditions or surgeries recently, use acceptable contraception if applicable, and cannot be pregnant or drug users. Those who've participated in other drug studies recently are excluded.

What is being tested?

The study is testing FB825's safety when given as a single subcutaneous injection compared to placebo in healthy adults. It's also looking at how the body processes the drug (pharmacokinetics). Some participants will receive FB825 intravenously for comparison.

What are the potential side effects?

Possible side effects aren't detailed here but generally could include reactions at the injection site, allergic responses to ingredients, or any unexpected health issues since it’s being tested for safety.

Eligibility Criteria

Inclusion Criteria

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

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I am 18-55 years old, a nonsmoker, with a healthy weight.

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I am a woman who cannot have children because I am post-menopausal or have been surgically sterilized.

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I am healthy with no major illnesses affecting my body systems.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't received any blood products or been in a study with FB825 in the last 6 months.

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I haven't donated plasma or lost a significant amount of blood in the last 2 months.

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I have a significant ongoing health issue, including asthma or allergies.

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I do not have hepatitis B, C, or HIV based on recent tests.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

AUC0-inf

AUC0-t

Cmax

+1 more

Secondary study objectives

CL/F

Kel

+7 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: cohort 3Experimental Treatment1 Intervention

300 mg single IV administration

Group II: cohort 2Experimental Treatment1 Intervention

FB825 450 mg or placebo with single SC administration in 3:1 ratio

Group III: cohort 1Experimental Treatment1 Intervention

FB825 300 mg or placebo with single SC administration in 3:1 ratio

0 / 7Eligibility 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 Atopic Dermatitis (AD) include topical corticosteroids, calcineurin inhibitors, and biologics like dupilumab. Topical corticosteroids work by suppressing the immune response to reduce inflammation. Calcineurin inhibitors, such as tacrolimus and pimecrolimus, inhibit T-cell activation, thereby decreasing inflammation. Dupilumab, a monoclonal antibody, targets the interleukin-4 receptor alpha subunit, blocking IL-4 and IL-13 signaling, which are key cytokines in AD's inflammatory pathway. These treatments are essential for AD patients as they address the underlying immune dysregulation and inflammation, providing symptom relief and improving quality of life.