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)

Bambusa Therapeutics

Status and phase: Enrolling; Phase 1

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: BBT002; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06944925

BBT002-001

Details and patient eligibility

About

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).

Full 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.

Enrollment: 286 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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286 participants in 14 patient groups, including a placebo group

Part A: BBT002

Experimental group

Description:

A single dose of BBT002 will be administered in healthy volunteers

Treatment:

Drug: BBT002

Part B: BBT002

Experimental group

Description:

Multiple doses of BBT002 will be administered in healthy volunteers.

Treatment:

Drug: BBT002

Part C: BBT002

Experimental group

Description:

Multiple doses of BBT002 will be administered in patients with COPD

Treatment:

Drug: BBT002

Part A: Placebo

Placebo Comparator group

Description:

A single dose of Placebo will be administered in healthy volunteers.

Treatment:

Drug: Placebo

Part B: Placebo

Placebo Comparator group

Description:

Multiple doses of Placebo will be administered in healthy volunteers.

Treatment:

Drug: Placebo

Part C: Placebo

Placebo Comparator group

Description:

Multiple doses of Placebo will be administered in patients with COPD.

Treatment:

Drug: Placebo

Part D: Placebo

Placebo Comparator group

Description:

Multiple doses of Placebo will be administered in patients with CRSwNP.

Treatment:

Drug: Placebo

Part E: Placebo

Placebo Comparator group

Description:

Single dose of Placebo will be administered in healthy volunteers.

Treatment:

Drug: Placebo

Part F: Placebo

Placebo Comparator group

Description:

Multiple doses of Placebo will be administered in patients with COPD.

Treatment:

Drug: Placebo

Part G: Placebo

Placebo Comparator group

Description:

Multiple doses of Placebo will be administered in patients with CRSwNP.

Treatment:

Drug: Placebo

Part D: BBT002

Experimental group

Description:

Multiple doses of BBT002 will be administered in patients with CRSwNP.

Treatment:

Drug: BBT002

Part E: BBT002

Experimental group

Description:

Single dose of BBT002 will be administered in healthy volunteers.

Treatment:

Drug: BBT002

Part F: BBT002

Experimental group

Description:

Multiple doses of BBT002 will be administered in patients with COPD.

Treatment:

Drug: BBT002

Part G: BBT002

Experimental group

Description:

Multiple doses of BBT002 will be administered in patients with CRSwNP.

Treatment:

Drug: BBT002