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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)

A Randomized, Double-Blind, Placebo-controlled, Single- and Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Clinical Activity of BBT002 in Healthy Volunteers and Patients With COPD or CRSwNP

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Injections

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "BBT002 will be given by intravenous injection or subcutaneous injection."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests single and repeated doses of BBT002 in healthy adults and adults with certain lung or sinus conditions. These conditions are COPD, a long-term lung disease that makes breathing hard, and CRSwNP, long-term sinus swelling with growths called nasal polyps.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18–65 if healthy, 35–80 if you have COPD, or 18–80 if you have CRSwNP.
  • If healthy, have a BMI of 18–32 and weigh no more than 120 kg. If you have COPD or CRSwNP, have a BMI of 16–35 and weigh no more than 125 kg. BMI compares weight with height.
  • If you can become pregnant, have a negative pregnancy test. Use suitable birth control if you or your partner can become pregnant.
  • Be willing to avoid alcohol for 24 hours before each study visit.
  • Be a nonsmoker, a former smoker, or a healthy current smoker who smokes no more than 5 cigarettes a day.
  • Have no major health findings or history of other relevant diseases.
  • For the COPD groups: have a documented COPD history and a breathing test ratio called FEV1/FVC below 0.70 after medicine that opens the airways.
  • For the CRSwNP groups: have a confirmed diagnosis of long-term sinus swelling with nasal polyps.

Who can't join

  • Test positive for HIV, hepatitis B, or hepatitis C.
  • Have a weak immune system, a disease where the immune system attacks the body, cancer, or a history of conditions that raise infection risk.
  • Have a history of major problems with how your body uses energy, your skin, liver, kidneys, blood, or other serious disorders.
  • Have important abnormal lab results, such as low blood counts or abnormal liver or kidney tests.
  • Have a positive drug or alcohol test or abnormal vital signs at screening or the day before treatment, or an abnormal ECG, a test of the heart’s electrical activity.
  • Have a history of drug or alcohol abuse in the past 2 years, or severe allergic reactions.
  • For the COPD groups: have another major lung disease, serious or unstable heart or blood vessel disease, a recent important infection, or be unable to do breathing tests.
  • For the CRSwNP groups: have symptoms that do not respond to steroids that treat the whole body, recent or extensive nose or sinus surgery, conditions that prevent nasal checks, or certain other nose, sinus, or whole-body diseases.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Key Inclusion Criteria (Parts A, B, C, D, E, F, and G) 1. 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) 2. 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) 3. Negative pregnancy tests for women of childbearing potential 4. Willingness to refrain from alcohol consumption for 24 hours prior to each study visit 5. Non-smokers, healthy current smokers (≤5 cigarettes/day), or ex-smokers 6. Adequate contraception use (for men and women of childbearing potential) 7. No clinically significant abnormalities or history of relevant diseases Key Inclusion Criteria (Part C and F only) 1. Documented history of COPD with a post-bronchodilator Forced Expiratory Volume in 1 second/Forced Vital Capacity less than 0.70 Key Inclusion Criteria (Parts D and G) 1\. Participants with confirmed diagnosis of CRSwNP Key Exclusion Criteria for (Parts A, B, C, D, E, F, and G) 1. Positive viral serology for human immunodeficiency virus (HlV), hepatitis C virus (HCV), or hepatitis B (HBV) 2. Immunodeficiencies, autoimmune diseases, or cancer, history of conditions predisposing to infections 3. History of major metabolic, dermatological, liver, kidney, hematological or other significant disorders 4. Clinically relevant abnormal lab results, including low blood counts, liver enzymes, or abnormal kidney function 5. Positive drug/alcohol tests or abnormal vital signs at screening or Day -1 6. Abnormal Electrocardiogram(ECG) findings 7. History of drug/alcohol abuse in the past 2 years 8. History of severe allergic reactions or hypersensitivity Key Exclusion Criteria (Part C and F only) 1. Current diagnosis of other significant pulmonary disease 2. Significant or unstable cardiovascular diseases 3. Recent clinically significant infection 4. Inability to perform spirometry Key Exclusion Criteria (Parts D and G) 1. Steroid refractoriness: Refractory to systemic corticosteriods for CRSwNP 2. Sinonasal surgery (recent/extensiv) 3. Consitions interfering with nasal assessments 4. Excluded sinonasal/systemic diseases

Study sites (3)

KY

NY