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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
• Intervention / Treatment: Drug: Placebo; Drug: BBT002

Detailed Description

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)

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Tracy Ji, Study Director; Phone Number: +86 18001322760; Email: Tracy.Ji@bambusatx.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100044
      • People's Hospital of Peking University
      • Contact: Min Wang; Phone Number: 010-88325988; Email: rmyyyljd@163.com
      • Principal Investigator: Min Wang
  • Guangdong
    • Guangzhou, Guangdong, China, 510630
      • The Third Affiliated Hospital of Sun Yat-Sen University
      • Principal Investigator: Qintai Yang
      • Contact: Qintai Yang; Phone Number: 020-85253153; Email: zssygcp@mail.sysu.edu.cn
  • Hunan
    • Changsha, Hunan, China, 410008
      • Xiangya Hospital of Central South University
      • Principal Investigator: Weihong Jiang
      • Contact: Weihong Jiang; Phone Number: 0731-84327918; Email: xyyygcp2010@126.com
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Jiangsu Province Hospital
      • Principal Investigator: Lei Cheng
      • Contact: Lei Cheng; Phone Number: 025-83714511; Email: jspent@126.com
  • Shandong
    • Jinan, Shandong, China, 250022
      • The Second Hospital of Shandong Province
      • Contact: Li Shi; Phone Number: 0531-83086465; Email: sdent2007@126.com
      • Principal Investigator: Li Shi
    • Qingdao, Shandong, China, 266003
      • Qingdao University Hospital
      • Principal Investigator: Yan Jiang
      • Contact: Yan Jiang; Phone Number: 0532-82911767; Email: jidi1767@126.com
    • Yantai, Shandong, China, 264000
      • The Affiliated Yuhuangding Hospital of Qingdao University
      • Principal Investigator: Xicheng Song
      • Contact: Xicheng Song; Phone Number: 0535-6679498; Email: gcp@ytyhdyy.com
    • Zibo, Shandong, China, 255036
      • Zibo Hospital of Shandong University
      • Principal Investigator: Wen Liu
      • Contact: Wen Liu; Phone Number: 0533-2361126; Email: gcpzbszxyy@163.com
      • Principal Investigator: Daoliang Song
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200127
      • Renji Hospital, Shanghai Jiao Tong University School of Medicine
      • Principal Investigator: Jiping Li
      • Contact: Jiping Li; Phone Number: 021-68383223; Email: rjyljg_new@163.com
  • Sichuang
    • Chengdu, Sichuang, China, 610017
      • The Second Hospital of Chengdu City
      • Contact: Jia Chen; Phone Number: 028-67830120; Email: yuanban2208@126.com
      • Principal Investigator: Jia Chen
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310014
      • Zhejiang People's Hospital
      • Contact: Lizhou Su; Phone Number: 0571-85893646; Email: zjsrmyygcp@163.com
    • Wenzhou, Zhejiang, China, 325024
      • The Second Affiliated Hospital of Wenzhou Medical University
      • Contact: Xuejun Liu; Phone Number: 0577-85676803; Email: wmuey2gcp@126.com
      • Principal Investigator: Xuejun Liu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria: Part (A&B):

1. Age of 18-55 years (HVs), 18-75 years (patients)
2. Body mass index between 18-30 kg/m², capped at 120 kg
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

Key Inclusion Criteria (Part B only)

1. Participants with physician-diagnosed CRSwNP for at least 12 months prior to randomization
2. SNOT-22 total score ≥30 at screening and randomization.
3. Documented systemic corticosteroid use (or contraindication/intolerance) within past 24 months.
4. Diagnosed asthma per GINA 2025, stable for ≥12 months. Stable on GINA Step 3 or higher therapy for 6 weeks before screening.

Exclusion Criteria:Part (A&B):

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 for (Part B only):

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A Single Ascending Dose BBT002; A single dose of BBT002 will be administered in healthy volunteers	Drug: BBT002; BBT002 will be administered in part A and part B
Placebo Comparator: Part A Single Ascending Dose Placebo; A single dose of Placebo will be administered in healthy volunteers.	Drug: Placebo; Placebo will be administered
Experimental: Part B Multiple Ascending Dose BBT002; Five doses of BBT002 will be administered in patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) and Comorbid Asthma	Drug: BBT002; BBT002 will be administered in part A and part B
Placebo Comparator: Part B Multiple Ascending Dose Placebo; Five doses of BBT002 will be administered in patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) and Comorbid Asthma	Drug: Placebo; Placebo will be administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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 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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK parameters- maximum observed concentration (Cmax)	Maximum observed concentration of the study drug in serum will be analyzed for all subjects	At specified timepoints pre-dose and up to 169 days post first dose administration
PK parameters- Time for maximum observed Concentration (Tmax)	Serum PK Tmax will be analyzed for all subjects	At specified timepoints pre-dose and up to 169 days post first dose administration
PK parameters- Area under the curve (AUC)	Area under the curve of the study drug in serum will be analyzed for all subjects	At specified timepoints pre-dose and up to 169 days post first dose administration
PK parameters- Volume of distribution (Vz)	Volume of distribution of the study drug in serum will be analyzed for all subjects	At specified timepoints pre-dose and up to 169 days post first dose administration
PK parameters- Total clearance (CL)	Total clearance of the study drug in serum will be analyzed for all subjects	At specified timepoints pre-dose and up to 169 days post first dose administration
PK parameters- - Elimination Half-life (t1/2)	Elimination half-life of the study drug in serum will be analyzed for all subjects	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).	Serum Anti-Drug Antibodies will be analyzed for all subject	At specified timepoints pre-dose and up to 169 days post first dose administration

Collaborators and Investigators

• Sponsor: Bambusa Therapeutics

Study record dates

Study Major Dates

• Study Start (Estimated): March 2, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 30, 2027

Study Registration Dates

• First Submitted: February 22, 2026
• First Submitted That Met QC Criteria: February 22, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 22, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: BBT002-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes