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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial tests a new drug to see if it is safe and effective for adults when given in a single shot.
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.Check my eligibility
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.See study design
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 belowSelect...
I am 18-55 years old, a nonsmoker, with a healthy weight.
Select...
I am a woman who cannot have children because I am post-menopausal or have been surgically sterilized.
Select...
I am healthy with no major illnesses affecting my body systems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
AUC0-inf
AUC0-t
Cmax
+1 moreSecondary outcome measures
CL
CL/F
Kel
+7 moreTrial 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
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Oneness Biotech Co., Ltd.Lead Sponsor
18 Previous Clinical Trials
1,222 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a man who can father children and will use birth control for about 6 months after treatment.I haven't received any blood products or been in a study with FB825 in the last 6 months.I haven't donated plasma or lost a significant amount of blood in the last 2 months.I haven't had any major illnesses or surgeries in the last 4 weeks.Your blood tests show low hemoglobin or platelet count, or high levels of AST, ALT, lipase, or serum creatinine. Any other abnormal lab results that the doctor thinks are important will also exclude you from the study.I am 18-55 years old, a nonsmoker, with a healthy weight.I have a significant ongoing health issue, including asthma or allergies.You are pregnant or breastfeeding.You have tested positive for drugs, nicotine, or alcohol in your urine or breath the day before the study starts.I agree to use birth control for 167 days after treatment.You have used illegal drugs in the past year, including marijuana within the past month or stronger drugs within the past 3 months.You are allergic to FB825 or similar drugs, or any ingredients in the medication.You have a history of factors that increase the risk of torsade de pointes syndrome.I do not have hepatitis B, C, or HIV based on recent tests.I have taken medication, including OTC, herbal, dietary supplements, or vitamins within the last 14 days.I agree to use a condom for 167 days after treatment if my partner is pregnant.I agree not to donate sperm for 167 days after treatment.You have a history of heavy alcohol use in the past year or regular alcohol use that exceeds 7 drinks per week for women or 14 drinks per week for men.I am a woman who cannot have children because I am post-menopausal or have been surgically sterilized.You have recently been to or live in a place where parasitic infections are common.I am healthy with no major illnesses affecting my body systems.
Research Study Groups:
This trial has the following groups:- Group 1: cohort 2
- Group 2: cohort 3
- Group 3: cohort 1
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the eligibility criteria for potential participants in this research?
"To enrol in this trial, potential patients should have atopic dermatitis and be within the ages of 18 to 55. Currently, 22 people are needed for complete recruitment."
Answered by AI
Are there currently recruiting opportunities for volunteers in this clinical research project?
"Clinicaltrials.gov reveals that this medical study, which was first published on May 3rd 2023 and last updated July 11th 2023, is not actively seeking participants at the moment. However, there are 219 other clinical trials searching for enrollees currently."
Answered by AI
Does the age of participants surpassing 70 years restrict them from taking part in this research?
"This medical trial is only open to patients aged 18-55, with 90 studies allocated for participants under the age of majority and 151 reserved for those over 65."
Answered by AI
Has cohort 1 been granted authorization by the FDA?
"Our team at Power assign a score of 1 to the safety rating of cohort 1, as this is an early-stage trial and there is scant evidence for its efficacy or harmlessness."
Answered by AI
What are the ultimate objectives of this clinical research?
"The clinical trial sponsor, Oneness Biotech Co., Ltd. is evaluating AUC0-inf as the primary outcome over a 24 month period of observation. Secondary outcomes like Tmax (Time of observed Cmax), T½ el (Elimination half-life) and Kel (Elimination rate constant) will also be assessed for this study."
Answered by AI
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