Actively Recruiting
Study to Evaluate Safety and Effects of BBT002 in Healthy Adults and Adults With Chronic Rhinosinusitis with Nasal Polyps, With or Without Asthma
Led by Bambusa Therapeutics · Updated on 2026-07-22
64
Participants Needed
12
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating BBT002, a drug being studied for its safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics, and clinical activity in healthy volunteers and people with Chronic Rhinosinusitis with Nasal Polyps CRSwNP, with or without asthma. This randomized, double-blind, placebo-controlled study includes participants from 18 to 75 years old and aims to understand how BBT002 behaves in the body and its effects on these conditions. The study has two parts Part A involves a single dose of BBT002 or placebo given to healthy volunteers in increasing dose groups. Part B includes patients with CRSwNP, with or without asthma, who receive five repeated doses of BBT002 or placebo. The doses are given sequentially, and the study monitors participants for safety and drug activity over time. Participants will undergo various assessments including monitoring for adverse events, vital signs, physical exams, laboratory tests, and ECG readings up to 141 days after a single dose in healthy volunteers and up to 169 days after the first dose in patients. Researchers will also measure how the drug is processed in the body and check for immune responses. The total study duration extends until June 2028, ensuring comprehensive evaluation throughout the treatment and follow-up periods.
CONDITIONS
Brief Title
A Study of BBT002 in Healthy Volunteers (HVs) and in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) With or Without Comorbid Asthma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 55 years for healthy volunteers; 18 to 75 years for patients with CRSwNP
- Body mass index between 18 and 30 kg/m², maximum weight 120 kg
- Negative pregnancy tests for women who can become pregnant
- Willing to avoid alcohol for 24 hours before each study visit
- Non-smokers, healthy light smokers (up to 5 cigarettes/day), or ex-smokers
- For patients: physician-diagnosed CRSwNP before screening
- For patients: SNOT-22 total score of 30 or higher at screening and randomization
- For patients: documented systemic corticosteroid use or intolerance in past 24 months
- For patients with asthma: diagnosis per GINA 2025, stable for at least 12 months
- For patients with asthma: stable on GINA Step 3 or higher therapy for 6 weeks before screening
- For patients with asthma: stable on regular asthma treatment if comorbid asthma is present
You will not qualify if you...
- Positive tests for HIV, hepatitis B, or hepatitis C viruses
- Immunodeficiencies, autoimmune diseases, cancer, or conditions increasing infection risk
- History of major metabolic, skin, liver, kidney, blood, or other serious disorders
- Abnormal lab results including low blood counts, liver enzymes, or kidney function
- Positive drug or alcohol tests or abnormal vital signs at screening or Day -1
- Abnormal electrocardiogram (ECG) findings
- History of drug or alcohol abuse in past 2 years
- History of severe allergic reactions or hypersensitivity
- For patients: any sinus or nasal surgery within 6 months before screening or more than 2 prior surgeries
- Concurrent nasal conditions interfering with study assessments
- Significant or unstable cardiovascular diseases
- Recent clinically significant infection
Research Team
T
Tracy Ji, Senior study Director
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