A Study of BBT002 in Healthy Volunteers (HVs) and in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) and Comorbid Asthma

NCT07436949 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: BBT002-003
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Outcome Measures

Primary Outcomes (5)

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

  Incidence, relatedness, and severity of AEs graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

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

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

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

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

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

  Physical examination will be assessed.

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

• Number of participants with change in Laboratory assessments

  Laboratory assessments include hematology, coagulation, clinical chemistry and urinalysis

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

• Number of participants with change in 12-lead ECG readings

  12-lead ECG will be assessed.

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

Secondary Outcomes (7)

• PK parameters- Area under the curve (AUC)

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

• PK parameters- maximum observed concentration (Cmax)

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

• PK parameters- Time for maximum observed Concentration (Tmax)

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

• PK parameters- Volume of distribution (Vz)

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

• PK parameters- Total clearance (CL)

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

Study Arms (4)

Part A Single Ascending Dose BBT002

EXPERIMENTAL

A single dose of BBT002 will be administered in healthy volunteers

Drug: BBT002

Part B Multiple Ascending Dose BBT002

EXPERIMENTAL

Five doses of BBT002 will be administered in patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) and Comorbid Asthma

Drug: BBT002

Part A Single Ascending Dose Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Part B Multiple Ascending Dose Placebo

PLACEBO COMPARATOR

Five doses of BBT002 will be administered in patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) and Comorbid Asthma

Drug: Placebo

Interventions

BBT002 DRUG

BBT002 will be administered in part A and part B

Part A Single Ascending Dose BBT002; Part B Multiple Ascending Dose BBT002

Placebo DRUG

Placebo will be administered

Part A Single Ascending Dose Placebo; Part B Multiple Ascending Dose Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Diagnosed asthma per GINA 2025, stable for ≥12 months. Stable on GINA Step 3 or higher therapy for 6 weeks before screening.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Bambusa Therapeutics: lead

Study Sites (12)

People's Hospital of Peking University

Beijing, Beijing Municipality, 100044, China

Location

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

Location

Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

Location

The Second Hospital of Shandong Province

Jinan, Shandong, 250022, China

Location

Qingdao University Hospital

Qingdao, Shandong, 266003, China

Location

The Affiliated Yuhuangding Hospital of Qingdao University

Yantai, Shandong, 264000, China

Location

Zibo Hospital of Shandong University

Zibo, Shandong, 255036, China

Location

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

Location

The Second Hospital of Chengdu City

Chengdu, Sichuang, 610017, China

Location

Zhejiang People's Hospital

Hangzhou, Zhejiang, 310014, China

Location

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325024, China

Location

Central Study Contacts

Tracy Ji, Study Director

CONTACT

+86 18001322760; Tracy.Ji@bambusatx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2026
• First Posted: February 27, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 30, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

CN (12)