ClinicalTrials.gg
RecruitingNCT07436949Updated Jul 22, 2026

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 interventional study of BBT002 and Placebo in Chronic Rhinosinusitis With Nasal Polyps (CRSwNP), sponsored by Bambusa Therapeutics. Recruiting at 12 sites in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-22.

Sponsored by Bambusa Therapeutics · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2026; still recruiting 8 months later.

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Phase
Phase 1/2
Study type
Interventional
Enrollment
64
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 46 studies in Nasal Polyps with a site in China — 17 open to participants now, 24 under way, 7 of them phase 3. Nasal Polyps · China.

Planned enrollment
28th of 43
64 · median 90
Started
2026
with 9 others
Phase 1/2
2 of 46
1 open now
Primary completion
2027-12
later than 17 of 23 live
Registered
41st of 46
by date
Lead sponsor
1 of 46
Bambusa Therapeutics

Among the 46 studies in Nasal Polyps with a site in China, this one is the 28th largest by planned enrollment of the 43 interventional ones that give a count, is one of 10 that started in 2026, is one of 2 in phase 1/2, reaches primary completion later than 17 of the 23 other live ones, and was the 41st registered.

Nasal Polyps

236 studies on the registry are indexed under Nasal Polyps; 68 are open to participants now.

Browse Nasal Polyps studies →

Open to participants now

17 of the 46 studies in Nasal Polyps with a site in China are open now. Recruiting first, the newest first:

11 more — sign in →

All 17 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 40 Nasal Polyps studies recruiting now, 22 (55%) set no upper age limit and 12 (30%) stop at 75 or younger; 2 take children under 18; 7 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 46 studies in Nasal Polyps with a site in China, or all of them as a file.
02

Study 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) 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)
03

Conditions studied

  • Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria: Part (A\&B):

  1. Age of 18-55 years (HVs), 18-75 years (patients)
  2. between 18-30 kg/m², capped at 120 kg
  3. Negative pregnancy tests for women of
  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 before screening.
  2. SNOT-22 total score ≥30 at screening and randomization.
  3. Documented systemic use (or /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.
  5. For the participants have comorbid asthma, they had to be stable using their regular asthma treatment.

Exclusion Criteria:Part (A\&B):

  1. Positive viral serology for (HlV), virus (HCV), or (HBV)
  2. Immunodeficiencies, diseases, or cancer, history of conditions predisposing to infections
  3. History of major metabolic, dermatological, liver, kidney, hematological or other significant disorders
  4. 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 (ECG) findings
  7. History of drug/alcohol abuse in the past 2 years
  8. History of severe allergic reactions or

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
Terms in these criteria, in plain language(11)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
64 participants (estimated)

Study arms

  • Experimental
    Part A Single Ascending Dose BBT002

    A single dose of BBT002 will be administered in healthy volunteers

    Drug: BBT002

  • Experimental
    Part B Multiple Ascending Dose BBT002

    Five doses of BBT002 will be administered in patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) with or without Asthma

    Drug: BBT002

  • Placebo comparator
    Part A Single Ascending Dose Placebo

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

    Drug: Placebo

  • Placebo comparator
    Part B Multiple Ascending Dose Placebo

    Five doses of BBT002 will be administered in patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) with or without Asthma

    Drug: Placebo

Interventions

  • DrugBBT002

    BBT002 will be administered.

  • DrugPlacebo

    Placebo will be administered

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

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

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

    Physical examination will be assessed.

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

  4. Number of participants with change in Laboratory assessments

    Laboratory assessments include hematology, coagulation, clinical chemistry and urinalysis

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

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

    12-lead ECG will be assessed.

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

Secondary outcomes

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

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

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

  2. PK parameters- maximum observed concentration (Cmax)

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

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

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

    Serum PK Tmax will be analyzed for all subjects

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

  4. PK parameters- Volume of distribution (Vz)

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

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

  5. PK parameters- Total clearance (CL)

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

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

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

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

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

  7. 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

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

07

Study locations

12 of 12 sites recruiting
  • People's Hospital of Peking University
    Beijing, Beijing Municipality 100044, China
    Recruiting
    • Min Wang · Contactrmyyyljd@163.com · 010-88325988
    • Min Wang · Principal investigator
  • The Third Affiliated Hospital of Sun Yat-sen University
    Guangzhou, Guangdong 510630, China
    Recruiting
  • Xiangya Hospital of Central South University
    Changsha, Hunan 410008, China
    Recruiting
    • Weihong Jiang · Contactxyyygcp2010@126.com · 0731-84327918
    • Weihong Jiang · Principal investigator
  • Jiangsu Province Hospital
    Nanjing, Jiangsu 210029, China
    Recruiting
    • Lei Cheng · Contactjspent@126.com · 025-83714511
    • Lei Cheng · Principal investigator
  • The Second Hospital of Shandong Province
    Jinan, Shandong 250022, China
    Recruiting
    • Li Shi · Contactsdent2007@126.com · 0531-83086465
    • Li Shi · Principal investigator
  • Qingdao University Hospital
    Qingdao, Shandong 266003, China
    Recruiting
    • Yan Jiang · Contactjidi1767@126.com · 0532-82911767
    • Yan Jiang · Principal investigator
  • The Affiliated Yuhuangding Hospital of Qingdao University
    Yantai, Shandong 264000, China
    Recruiting
    • Xicheng Song · Contactgcp@ytyhdyy.com · 0535-6679498
    • Xicheng Song · Principal investigator
  • Zibo Hospital of Shandong University
    Zibo, Shandong 255036, China
    Recruiting
    • Wen Liu · Contactgcpzbszxyy@163.com · 0533-2361126
    • Daoliang Song · Principal investigator
    • Wen Liu · Principal investigator
  • Renji Hospital, Shanghai Jiao Tong University School of Medicine
    Shanghai, Shanghai Municipality 200127, China
    Recruiting
    • Jiping Li · Contactrjyljg_new@163.com · 021-68383223
    • Jiping Li · Principal investigator
  • The Second Hospital of Chengdu City
    Chengdu, Sichuang 610017, China
    Recruiting
  • Zhejiang People's Hospital
    Hangzhou, Zhejiang 310014, China
    Recruiting
  • The Second Affiliated Hospital of Wenzhou Medical University
    Wenzhou, Zhejiang 325024, China
    Recruiting
    • Xuejun Liu · Contactwmuey2gcp@126.com · 0577-85676803
    • Xuejun Liu · Principal investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2026 (actual). Primary completion is estimated for Dec 2027, 21 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 22, 2026
First posted
Feb 27, 2026
StartActual
Mar 2, 2026
Primary completionEst.
Dec 31, 2027
CompletionEst.
Jun 30, 2028
Last update
Jul 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07436949
Lead sponsor
Bambusa Therapeutics
Responsible party
Sponsor
First posted
Feb 27, 2026
Start date
Mar 2, 2026
Primary completion
Dec 31, 2027 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
Jul 22, 2026

Study contacts

Tracy Ji, Senior study Director
Contact
Tracy.Ji@bambusatx.com
+86 18001322760

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: BBT002

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