Atopic Dermatitis study: BYN-001
Official title A Study of BYN-001 in Healthy Adults and in Adults With Moderate to Severe Atopic Dermatitis
ClinicalTrials.gov ID: NCT07746817
What this study is testing
What is BYN-001?
BYN-001 is an investigational injectable medicine being studied as a potential treatment for atopic dermatitis. It is designed to block a specific protein in the body called IL-25 that may contribute to skin inflammation and itching.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see how safe and well tolerated BYN-001 is, and to learn how it behaves in the body. It also looks at whether the drug affects the immune system.
- Who it's for
- Healthy adults and adults who have moderate to severe atopic dermatitis.
- What's involved
- Participants will receive either BYN-001 or a placebo in a series of doses. They will have regular clinic visits, blood tests, and other safety checks to monitor the drug’s effects.
- Time commitment
- The study lasts several weeks to months, with multiple scheduled visits for dosing and monitoring.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- Part A and B Key
- Age 18-55 years of age
- Must be in good health with no significant medical conditions
- Willing and able to attend all study visits and comply with study requirements
- Able and willing to provide written informed consent Part A and B
You likely can't join if
- Evidence of clinically significant condition or disease
- Any physical or psychosocial condition that prohibits study completion
- Know history of illicit drug use or abuse, alcoholism and/or smoking more than -5 cigarettes a day in the prior 3 months
- History of sever allergic reactions of hypersensitivity Part C Inclusion Criteria
- Age 18-55 years of age
- Must be in good health with no significant medical conditions
See the full eligibility criteria
- Part A and B Key
- Age 18-55 years of age
- Must be in good health with no significant medical conditions
- Willing and able to attend all study visits and comply with study requirements
- Able and willing to provide written informed consent Part A and B
- Evidence of clinically significant condition or disease
- Any physical or psychosocial condition that prohibits study completion
- Know history of illicit drug use or abuse, alcoholism and/or smoking more than -5 cigarettes a day in the prior 3 months
- History of sever allergic reactions of hypersensitivity Part C Inclusion Criteria
- Age 18-55 years of age
- Must be in good health with no significant medical conditions
- Willing and able to attend all study visits and comply with study requirements
- Able and willing to provide written informed consent
- Documented chromic atopic dermatitis within 1 year prior to screening
- Moderate to severe atopic dermatitis Part C Key Exclusion Criteria
- Evidence of clinically significant condition or disease
- Any physical or psychosocial condition that prohibits study completion
- Know history of illicit drug use or abuse, alcoholism and/or smoking more than 5 cigarettes a day in the prior 3 months
- History of sever allergic reactions of hypersensitivity
- Incomplete washout of prior atopic dermatitis medications
- Other confounding skin diseases
The study team makes the final eligibility decision.
Where it is enrolling
- Melbourne, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Melbourne, Victoria, Australia. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.