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Recruiting NCT06944925

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)

Phase I Interventional Chronic Obstructive Pulmonary Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BBT002, Placebo.
Who it may be relevant to
Registry conditions: Chronic Obstructive Pulmonary Disease. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Georgia, New Zealand, Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Detailed description

This study a is a randomized, double-blinded, placebo-controlled single (SAD) and multiple-ascending dose (MAD) study to evaluate safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics, and exploratory clinical activity of BBT002 in healthy volunteers (HVs) and in adult patients with COPD or CRSwNP. BBT002 is a drug candidate being developed for the treatment of COPD or CRSwNP. BBT002 will be given by intravenous injection or subcutaneous injection.

Interventions

  • Drug BBT002
    BBT002 will be administered.
  • Drug Placebo
    Placebo will be administered.

Primary outcome measures

  • Number of participants with adverse events following single and multiple administration of BBT002 [Time frame: Parts A and E - up to 141 days post first dose administration; Parts B, C, D, F, and G - up to 169 days post first dose administration]
  • Number of participants with change in Laboratory assessments [Time frame: Parts A and E - up to 141 days post first dose administration; Parts B, C, D, F, and G - up to 169 days post first dose administration]
  • Number of participants with change in vital sign measurements following dose administration. [Time frame: Parts A and E - up to 141 days post first dose administration; Parts B, C, D, F, and G - up to 169 days post first dose administration]
  • Number of participants with change in physical examination following dose administration. [Time frame: Parts A and E - up to 141 days post first dose administration; Parts B, C, D, F, and G - up to 169 days post first dose administration]
  • Number of participants with change in 12-lead ECG readings [Time frame: Parts A and E - up to 141 days post first dose administration; Parts B, C, D, F, and G - up to 169 days post first dose administration]
Secondary outcome measures (7)
  • PK parameters- maximum observed concentration (Cmax) [Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration]
  • PK parameters- Time of maximum observed Concentration (Tmax) [Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration]
  • PK parameters- Area under the curve (AUC) [Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration]
  • PK parameters- Volume of distribution (Vz) [Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration]
  • PK parameters- Total clearance (CL) [Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration]
  • PK parameters- - Elimination Half-life (t1/2). [Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration]
  • The immunogenicity of BBT002 is measured as the number and percentage of subjects who develop Anti-Drug Antibodies (ADA). [Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration]

Eligibility criteria

Key Inclusion Criteria (Parts A, B, C, D, E, F, and G)

  • 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

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)

  • 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
  • Positive drug/alcohol tests or abnormal vital signs at screening or Day -1
  • Abnormal Electrocardiogram(ECG) findings
  • History of drug/alcohol abuse in the past 2 years
  • History of severe allergic reactions or hypersensitivity

Key Exclusion Criteria (Part C and F only)

  • Current diagnosis of other significant pulmonary disease
  • Significant or unstable cardiovascular diseases
  • Recent clinically significant infection
  • Inability to perform spirometry

Key Exclusion Criteria (Parts D and G)

  • Steroid refractoriness: Refractory to systemic corticosteriods for CRSwNP
  • Sinonasal surgery (recent/extensiv)
  • Consitions interfering with nasal assessments
  • Excluded sinonasal/systemic diseases

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Triple blind
Primary purpose
Treatment

Study locations

Georgia · 4 centers
  • Aleksandre Aladashvili Clinic LLC — Tbilisi
  • Geo Hospitals Tbilisi Multiprofile Medical Center — Tbilisi
  • LEPL The First University Clinic of Tbilisi State Medical University — Tbilisi
  • Ltd Aversi Clinic — Tbilisi
United States · 3 centers
  • Equity Medical Bowling Green — Bowling Green
  • Equity Medical - Owensboro — Owensboro
  • Equity Medical LLC — New York
New Zealand · 3 centers
  • Momentum Clinical Research Hamilton — Rotorua
  • Momentum Clinical Research — Pukekohe
  • Momentum Clinical Research — Wellington
Australia · 2 centers
  • Linear Clinical Research — Perth
  • Momentum Clinical Research — Brisbane
Poland · 2 centers
  • Uniwersyteckie Centrum Kliniczne Osrodka Badan Klinicznych Wczesnych Faz — Gdansk
  • Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. — Krakow

Identifiers

NCT: NCT06944925 · BBT002-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗