A Study of BBT001 in Healthy Volunteers (HVs) and in Adult Patients With Moderate to Severe Atopi… (NCT07239947) | Clinical Trial Compass
RecruitingPhase 1
A Study of BBT001 in Healthy Volunteers (HVs) and in Adult Patients With Moderate to Severe Atopic Dermatitis (AD)
China99 participantsStarted 2025-08-09
Plain-language summary
This is a Phase 1, randomized, blinded, placebo controlled, single ascending dose (SAD) study of BBT001 in healthy volunteers (HVs) and adult patients with moderate to severe Atopic Dermatitis (AD).
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age of 18-65 years.
. Body mass index between 18-28 kg/m², capped at 120 kg.
. Negative pregnancy tests for women of childbearing potential.
. Willingness to refrain from alcohol consumption for 24 hours prior to each study visit.
. Non-smokers, healthy current smokers (≤5 cigarettes/day), or ex-smokers.
. Adequate contraception use (for men and women of childbearing potential).
. No clinically significant abnormalities or history of relevant diseases.
. Must have dermatologist-confirmed chronic atopic dermatitis (≥12 months). Inadequate response to topical treatments or where they are medically inadvisable.
Exclusion criteria
. Significant health issues, such as: diabetes, positive tests for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B surface antigen (HBsAg), immunodeficiencies, autoimmune diseases, or cancer, history of conditions predisposing to infections.
. History of major metabolic, dermatological, liver, kidney, hematological, or other significant disorders.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with adverse events following single and multiple administration of BBT001
Timeframe: Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration
2
Number of participants with change in vital sign measurements following treatment administration.
Timeframe: Part A- Up to Day 141; Part B-Up to Day 169 post first dose administration
3
Number of participants with change in serum blood parameters.
Timeframe: Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration
4
Number of participants with change in physical examination following treatment administration.
Timeframe: Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration
5
Number of participants with change in 12-lead electrocardiogram (ECG) results measurements following treatment administration.
Timeframe: Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration