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NCT Number: NCT07436949

A Study of BBT002 in Healthy Volunteers (HVs) and in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) With or Without Comorbid Asthma

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) with or without Asthma.

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Key information

Conditions

Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

People's Hospital of Peking University, Beijing, Beijing Municipality, China

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About this study

The study consists of two parts:

  • Part A (single dose in HVs in sequential ascending dose cohorts, SAD in HVs part)
  • Part B (five repeated doses in patients with CRSwNP, MAD in patients part)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Part (A&B):

  • 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

Key Inclusion Criteria (Part B only)

  • Participants with physician-diagnosed CRSwNP before screening.
  • SNOT-22 total score ≥30 at screening and randomization.
  • Documented systemic corticosteroid use (or contraindication/intolerance) within past 24 months.
  • Diagnosed asthma per GINA 2025, stable for ≥12 months. Stable on GINA Step 3 or higher therapy for 6 weeks before screening.
  • For the participants have comorbid asthma, they had to be stable using their regular asthma treatment.

Exclusion criteria

Part (A&B):

  • 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 for (Part B only):

  • Any sinus/nasal surgery (including polypectomy) within 6 months before screening, History of >2 prior sinus/nasal surgeries
  • Concurrent nasal conditions that may interfere with study assessments
  • Significant or unstable cardiovascular diseases
  • Recent clinically significant infection

Treatment and study plan

BBT002

Drug

BBT002 will be administered.

Placebo

Drug

Placebo will be administered

Primary outcomes

  1. Number of participants with adverse events following single and multiple administration of BBT002

    Time frame: Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration

    Incidence, relatedness, and severity of AEs graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v6.0.

  2. Number of participants with change in vital sign measurements following dose administration.

    Time frame: Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration

    Changes in vital sign measurements, physical examination, clinical laboratory test findings, and 12-lead results.

  3. Number of participants with change in physical examination following dose administration.

    Time frame: Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration

    Physical examination will be assessed.

  4. Number of participants with change in Laboratory assessments

    Time frame: Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration

    Laboratory assessments include hematology, coagulation, clinical chemistry and urinalysis

  5. Number of participants with change in 12-lead ECG readings

    Time frame: Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration

    12-lead ECG will be assessed.

Secondary outcomes

  1. PK parameters- Area under the curve (AUC)

    Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration

    Area under the curve of the study drug in serum will be analyzed for all subjects

  2. PK parameters- maximum observed concentration (Cmax)

    Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration

    Maximum observed concentration of the study drug in serum will be analyzed for all subjects

  3. PK parameters- Time for maximum observed Concentration (Tmax)

    Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration

    Serum PK Tmax will be analyzed for all subjects

  4. PK parameters- Volume of distribution (Vz)

    Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration

    Volume of distribution of the study drug in serum will be analyzed for all subjects

  5. PK parameters- Total clearance (CL)

    Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration

    Total clearance of the study drug in serum will be analyzed for all subjects

  6. PK parameters- - Elimination Half-life (t1/2)

    Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration

    Elimination half-life of the study drug in serum will be analyzed for all subjects

  7. 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

    Serum Anti-Drug Antibodies will be analyzed for all subject

Study contacts

Contact information is provided by the study sponsor or research team.

Tracy Ji, Senior study Director

CONTACT

[email protected]

+86 18001322760

Sponsors and collaborators

Lead sponsor

Bambusa Therapeutics

Industry

Registry information

Official study 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 Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) With or Without Comorbid Asthma

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Feb 27, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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