A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Clinical Activity of BBT002 in Healthy Volunteers and Patients with Chronic Obstructive Pulmonary Disease (COPD) or Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) and Comorbid Asthma

Status Authorised, recruitment pending · 1 EU/EEA countries · 7 sites · Protocol BBT002-001

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - First administration to humans

Status Authorised, recruitment pending

Participants planned 134

Countries 1

Sites 7

Chronic Obstructive Pulmonary Disease (COPD) Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) Comorbid Asthma

Key facts

Sponsor: Bambusa Therapeutics Inc.
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Decision date (initial): 2026-02-16
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No

External identifiers

EU CT number: 2025-523142-28-00
ClinicalTrials.gov: NCT06944925

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Chronic Obstructive Pulmonary Disease (COPD) Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) Comorbid Asthma

Version	Level	Code	Term	System organ class
20.0	PT	10003553	Asthma	100000004855
27.0	PT	10080060	Chronic rhinosinusitis with nasal polyps	100000004855
21.1	LLT	10010952	COPD	10038738
28.0	LLT	10077006	Asthma-COPD overlap syndrome	10038738

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bambusa Therapeutics Inc.

Sponsor organisation: Bambusa Therapeutics Inc.
Address: 22 Boston Wharf Road Floor 7
City: Boston
Postcode: 02210-3032
Country: United States

Scientific contact point

Organisation: Bambusa Therapeutics Inc.
Contact name: Thang Ho

Public contact point

Organisation: Bambusa Therapeutics Inc.
Contact name: Lisa Li

Locations

1 EU/EEA country · 7 investigational sites

By country

Country	MS status	Planned subjects	Sites
Poland	Authorised, recruitment pending	36	7
Rest of world Georgia, Australia, China	—	98	—

Investigational sites

Poland

7 sites · Authorised, recruitment pending

Centrum Wsparcia Badań Klinicznych Pomorskiego Uniwersytetu Medycznego w Szczecinie

Centrum Wsparcia Badań Klinicznych, ul. Unii Lubelskiej 1, 71-252, Szczecin

Bioresearch Group Sp. z o.o.

Bioresearch Group, Ul. Mokra 7, Kajetany, Nadarzyn

Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.

Centrum Nowoczesnych Terapii, Plac Szczepanski 3, 31-011, Cracow