A Study of BBT002 in Healthy Volunteers (HVs) and in Adult Patients With Chronic Obstructive Pulm… (NCT06944925) | Clinical Trial Compass
RecruitingPhase 1
A Study of BBT002 in Healthy Volunteers (HVs) and in Adult Patients With Chronic Obstructive Pulmonary Disease (COPD) or Chronic Rhiosininusitis With Nasal Polyps (CRSwNP)
United States, Australia, Georgia286 participantsStarted 2025-05-08
Plain-language summary
Randomized study of single and multiple doses of BBT002 in healthy volunteers and in adult patients with chronic obstructive pulmonary disease (COPD) or chronic rhinosinusitis with nasal polyps (CRSwNP).
Who can participate
Age range
18 Years – 80 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 18-65 years for HVs (Parts A, B, and E); age 35-80 years for patients with COPD (Parts C and F,); age 18-80 for patients with CRSwNP (Parts D and G)
. Body mass index between 18.0-32.0 kg/m square, capped weight at 120kg, for HVs (Parts A, B, and E); body mass index between 16.0-35.0 kg/m square, capped weight at 125kg for patients (Parts C, D, F, and G)
. 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)
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.
1Since this is a Phase 1 trial primarily measuring safety — like adverse events, vital signs, and ECG changes — rather than whether BBT002 actually improves my COPD symptoms, is it worth discussing whether my current stage of COPD is better served by an established treatment first?
2The trial includes both healthy volunteers and people with COPD, so how does my doctor think the safety profile seen in healthy volunteers so far might or might not translate to someone with my lung condition?
3Because this study involves both single and multiple doses of a brand-new drug called BBT002, what kinds of adverse events or changes to my heart rhythm or lab results would my doctor want me to watch out for if I were to participate?
4This trial also enrolls people with chronic rhinosinusitis with nasal polyps — does my doctor think there's anything about that broader eligibility that could affect what we learn about COPD specifically, and how that might matter for me?
5Given that BBT002 is still in Phase 1 and the trial is actively recruiting, what does my doctor think about the timing — would waiting for Phase 2 or Phase 3 results give us more information about effectiveness before making a decision?
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 BBT002
Timeframe: Parts A and E - up to 141 days post first dose administration; Parts B, C, D, F, and G - up to 169 days post first dose administration
2
Number of participants with change in Laboratory assessments
Timeframe: Parts A and E - up to 141 days post first dose administration; Parts B, C, D, F, and G - up to 169 days post first dose administration
3
Number of participants with change in vital sign measurements following dose administration.
Timeframe: Parts A and E - up to 141 days post first dose administration; Parts B, C, D, F, and G - up to 169 days post first dose administration
4
Number of participants with change in physical examination following dose administration.
Timeframe: Parts A and E - up to 141 days post first dose administration; Parts B, C, D, F, and G - up to 169 days post first dose administration
5
Number of participants with change in 12-lead ECG readings
Timeframe: Parts A and E - up to 141 days post first dose administration; Parts B, C, D, F, and G - up to 169 days post first dose administration