Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)Phase 1/2NCT07436949
A Study of BBT002 in Healthy Volunteers (HVs) and in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) With or Without Comorbid Asthma
A Phase 1/2 study testing BBT002 in people with Chronic Rhinosinusitis With Nasal Polyps (CRSwNP), run by Bambusa Therapeutics at 12 sites in China.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
- What is being tested?
- BBT002
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 12 sitesChina
- Study dates
- 2 Mar 2026to 30 Jun 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 before screening.
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
China12 sites, 12 recruiting
- Recruiting
People's Hospital of Peking University
Beijing, Beijing Municipality, 100044
Min Wang, 010-88325988, rmyyyljd@163.com
Min Wang
- Recruiting
Xiangya Hospital of Central South University
Changsha, Hunan, 410008
Weihong Jiang, 0731-84327918, xyyygcp2010@126.com
Weihong Jiang
- Recruiting
The Second Hospital of Chengdu City
Chengdu, Sichuang, 610017
Jia Chen, 028-67830120, yuanban2208@126.com
Jia Chen
- Recruiting
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
Qintai Yang, 020-85253153, zssygcp@mail.sysu.edu.cn
Qintai Yang
- Recruiting
Zhejiang People's Hospital
Hangzhou, Zhejiang, 310014
Lizhou Su, 0571-85893646, zjsrmyygcp@163.com
- Recruiting
The Second Hospital of Shandong Province
Jinan, Shandong, 250022
Li Shi, 0531-83086465, sdent2007@126.com
Li Shi
- Recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Lei Cheng, 025-83714511, jspent@126.com
Lei Cheng
- Recruiting
Qingdao University Hospital
Qingdao, Shandong, 266003
Yan Jiang, 0532-82911767, jidi1767@126.com
Yan Jiang
- Recruiting
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
Jiping Li, 021-68383223, rjyljg_new@163.com
Jiping Li
- Recruiting
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325024
Xuejun Liu, 0577-85676803, wmuey2gcp@126.com
Xuejun Liu
- Recruiting
The Affiliated Yuhuangding Hospital of Qingdao University
Yantai, Shandong, 264000
Xicheng Song, 0535-6679498, gcp@ytyhdyy.com
Xicheng Song
- Recruiting
Zibo Hospital of Shandong University
Zibo, Shandong, 255036
Wen Liu, 0533-2361126, gcpzbszxyy@163.com
Daoliang Song
About this study
Official 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
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.
Read the 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)
- Being tested
- BBT002, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BBT002Drug
BBT002 will be administered.
PlaceboDrug
Placebo will be administered
| Study group | Role | What they receive |
|---|---|---|
| Part A Single Ascending Dose BBT002 | Experimental | A single dose of BBT002 will be administered in healthy volunteers Receives: 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) with or without Asthma Receives: Drug: BBT002 |
| Part A Single Ascending Dose Placebo | Placebo comparator | A single dose of Placebo will be administered in healthy volunteers. Receives: 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) with or without Asthma Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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) v6.0.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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)
Area under the curve of the study drug in serum will be analyzed for all subjects
Measured: At specified timepoints pre-dose and up to 169 days post first dose administration
PK parameters- maximum observed concentration (Cmax)
Maximum observed concentration of the study drug in serum will be analyzed for all subjects
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At specified timepoints pre-dose and up to 169 days post first dose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start2 Mar 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bambusa Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07436949
- Sponsor's protocol ID
- BBT002-003
- Status last verified
- Jul 2026
- First submitted
- 22 Feb 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07436949
- Acronym / sponsor ID
- BBT002-003
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Bambusa TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A Single Ascending Dose BBT002 | Experimental | Drug: BBT002A single dose of BBT002 will be administered in healthy volunteers |
| Part B Multiple Ascending Dose BBT002 | Experimental | Drug: BBT002Five doses of BBT002 will be administered in patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) with or without Asthma |
| Part A Single Ascending Dose Placebo | Placebo comparator | Drug: PlaceboA single dose of Placebo will be administered in healthy volunteers. |
| Part B Multiple Ascending Dose Placebo | Placebo comparator | Drug: PlaceboFive doses of BBT002 will be administered in patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) with or without Asthma |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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 exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BBT002BBT002 will be administered. | Drug | Part A Single Ascending Dose BBT002, Part B Multiple Ascending Dose BBT002 |
| PlaceboPlacebo will be administered | Drug | Part A Single Ascending Dose Placebo, Part B Multiple Ascending Dose Placebo |
Primary outcome
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.
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.
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.
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
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.
7 secondary outcomes
PK parameters- Area under the curve (AUC)
Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration
PK parameters- maximum observed concentration (Cmax)
Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration
PK parameters- Time for maximum observed Concentration (Tmax)
Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration
PK parameters- Volume of distribution (Vz)
Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration
PK parameters- Total clearance (CL)
Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration
PK parameters- - Elimination Half-life (t1/2)
Time frame: 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).
Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BBT002 in people with Chronic Rhinosinusitis With Nasal Polyps (CRSwNP), run by Bambusa Therapeutics at 12 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tracy Ji, Senior study Director (+86 18001322760, Tracy.Ji@bambusatx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.