Testing BBT002 in Healthy Volunteers and Adults With COPD or Nasal Polyps
Tests BBT002 against placebo in healthy adults and in adults with COPD or nasal polyps.
Plain-language title generated from the registry record
Registry title: 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)
Key facts
- Where
- Tbilisi, GeorgiaSee the 4 sites
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for healthy volunteers and for adults with COPD or chronic rhinosinusitis with nasal polyps (CRSwNP). It tests the drug BBT002 against a placebo.
- Age
- 18-65 years for healthy volunteers; 35-80 years for people with COPD; 18-80 years for people with CRSwNP.
- Sex
- Men and women can join.
- Disease stage
- COPD: a documented history of COPD with a post-bronchodilator Forced Expiratory Volume in 1 second/Forced Vital Capacity less than 0.70. CRSwNP: a confirmed diagnosis.
- Earlier treatment
- People with CRSwNP cannot join if their disease does not respond to systemic corticosteroids. People with recent or extensive sinonasal surgery cannot join.
Main reasons for not taking part
- Positive test for HIV, hepatitis C or hepatitis B
- Immune deficiency, autoimmune disease or cancer
- Other significant lung disease, or unstable heart or blood vessel disease (COPD parts)
- Inability to do spirometry (COPD parts)
- History of drug or alcohol abuse in the past 2 years
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT06944925, who can take part
Where in Georgia
- Aleksandre Aladashvili Clinic LLCTbilisi, GeorgiaTaking people
- Geo Hospitals Tbilisi Multiprofile Medical CenterTbilisi, GeorgiaTaking people
- LEPL The First University Clinic of Tbilisi State Medical UniversityTbilisi, GeorgiaTaking people
- LTD Aversi ClinicTbilisi, GeorgiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bambusa Therapeutics
- Trial code
- NCT06944925EU 2025-523142-28-00
- Record updated
- 1 July 2026
- Original description
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).Read full original descriptionShow less
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
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).
Inclusion: 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); No clinically significant abnormalities or history of relevant diseases; Participants with confirmed diagnosis of CRSwNP.
Exclusion: Positive drug/alcohol tests or abnormal vital signs at screening or Day -1; Steroid refractoriness: Refractory to systemic corticosteriods for CRSwNP; Sinonasal surgery (recent/extensiv); Positive viral serology for human immunodeficiency virus (HlV), hepatitis C virus (HCV), or hepatitis B (HBV); Immunodeficiencies, autoimmune diseases, or cancer, history of conditions predisposing to infections; History of major metabolic, dermatological, liver, kidney, hematological or other significant disorders; History of drug/alcohol abuse in the past 2 years; History of severe allergic reactions or hypersensitivity; Current diagnosis of other significant pulmonary disease; Significant or unstable cardiovascular diseases; Recent clinically significant infection; Excluded sinonasal/systemic diseases; Clinically relevant abnormal lab results, including low blood counts, liver enzymes, or abnormal kidney function; Abnormal Electrocardiogram(ECG) findings; Inability to perform spirometry; Consitions interfering with nasal assessments.