A Study of BBT002 in Healthy Volunteers (HVs) and in Patients With Chronic Rhinosinusitis With Na… (NCT07436949) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
A Study of BBT002 in Healthy Volunteers (HVs) and in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) and Comorbid Asthma
China64 participantsStarted 2026-03-02
Plain-language summary
This study is 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 Participants with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) and Comorbid Asthma.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Age of 18-55 years (HVs), 18-75 years (patients)
✓. Body mass index between 18-30 kg/m², capped at 120 kg
✓. 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
✓. Participants with physician-diagnosed CRSwNP for at least 12 months prior to randomization
✓. SNOT-22 total score ≥30 at screening and randomization.
✓. Documented systemic corticosteroid use (or contraindication/intolerance) within past 24 months.
Exclusion criteria
✕. 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
✕. Clinically relevant abnormal lab results, including low blood counts, liver enzymes, or abnormal kidney function
✕
What they're measuring
1
Number of participants with adverse events following single and multiple administration of BBT002
Timeframe: Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration
2
Number of participants with change in vital sign measurements following dose administration.
Timeframe: Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration
3
Number of participants with change in physical examination following dose administration.
Timeframe: Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration
4
Number of participants with change in Laboratory assessments
Timeframe: Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration
5
Number of participants with change in 12-lead ECG readings
Timeframe: Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration