Evaluating BBT002 in Healthy Volunteers and COPD Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics, and exploratory clinical activity of BBT002 through a randomized, blinded, placebo-controlled approach. It consists of three parts: Part A involves single ascending doses in healthy volunteers, Part B involves multiple ascending doses in healthy volunteers, and Part C involves multiple ascending doses in adult patients with Chronic Obstructive Pulmonary Disease (COPD). The study aims to gather comprehensive data on the drug's effects and safety profile.

Why it matters

Who can join: the full rules

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

Where it's running

• Equity Medical Bowling Green
  Bowling Green, Kentucky, United States Recruiting
• Equity Medical LLC
  New York, New York, United States Recruiting
• Linear Clinical Research
  Perth, Western Australia, Australia Recruiting
• Momentum Clinical Research
  Brisbane, Australia Recruiting
• Aleksandre Aladashvili Clinic LLC
  Tbilisi, Georgia Recruiting
• Geo Hospitals Tbilisi Multiprofile Medical Center
  Tbilisi, Georgia Recruiting

Study contacts

• Study coordinator: Tracy Ji
• Email: Tracy.Ji@bambusatx.com
• Phone: +86 18001322760

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Flutter therapy added to chest physiotherapy after CABG in COPD patients

  This study tests whether adding Flutter therapy to standard chest physiotherapy helps post-CABG patients with mild-to-moderate COPD improve breathing more than chest physiotherapy alone.

  Recruiting Foundation University Islamabad · Rawalpindi · NCT07875049

• TPB-based cadence exercise and breathing training for COPD patients

  A TPB-based program tests whether breathing training, cadence-guided walking, or both can improve lung function, exercise capacity, and quality of life in adults with COPD.

  Recruiting Fu Jen Catholic University Hospital · New Taipei City, New Taipei City and 1 other locations · NCT07860008

• See how dynamic chest X-rays relate to COPD patterns and progression risk

  This study looks at existing dynamic chest radiography data to see if new imaging measurements can identify COPD patterns, gauge severity, and predict who may experience faster progression.

  Recruiting Nanfang Hospital, Southern Medical University · Guangzhou, Guangdong · NCT07762573

• Personalized mobile app warnings to reduce COPD flares

  A personalized mobile app tests whether providing temperature-related risk warnings and protective tips, in addition to usual COPD care, can lower COPD flare-ups over 12 months.

  Recruiting at 4 sites Centers for Disease Control and Prevention, China · Beijing and 3 other locations · NCT07656142

• CLEAR model to predict when people with severe COPD can be taken off ventilatory support

  This project will see if the CLEAR model can predict which adults with severe COPD on invasive or non‑invasive ventilation can be safely taken off ventilatory support.

  Recruiting Assiut University · Asyut, Assuit Egypt · NCT07579052

• Long-term safety of Tozorakimab in COPD patients with prior exacerbations

  This study tests two long-term dosing regimens of tozorakimab in people with COPD who have a history of flare-ups and who completed earlier studies.

  Recruiting at 5 sites Phase 3 AstraZeneca · Aix-en-Provence and 12 other locations · NCT07566195

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.