Chronic Obstructive Pulmonary Disease (COPD)Phase 1NCT07288554
A Study of BBT002 in Healthy Volunteers (HVs) and in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 1 study testing BBT002 in people with Chronic Obstructive Pulmonary Disease (COPD), run by Bambusa Therapeutics at 11 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 Obstructive Pulmonary Disease (COPD). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- BBT002
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 11 sitesChina
- Study dates
- 5 Sep 2025to 30 May 2027
- Phase
- Phase 1
- 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 18-65 years (HVs), 35-75 years (patients)
- Body mass index between 18-32 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
- Adequate contraception use (for men and women of childbearing potential)
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- No clinically significant abnormalities or history of relevant diseases
- Documented history of COPD with a post-bronchodilator FEV1/FVC < 0.70
- FEV1 ≥ 30% and FEV1<80% predicted at screening.
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
- Current diagnosis of other significant pulmonary disease
- Significant or unstable cardiovascular diseases
- Recent clinically significant infection
- Inability to perform spirometry
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
China11 sites, 11 recruiting
- Recruiting
Chengdu fifth People's Hospital
Chengdu, Sichuang, 611130
Xiao Liu, 028-962120, sccd5120@163.com
Xiao Liu
- Recruiting
The third affiliated hosptial of Guangzhou Medical University
Guangzhou, Guangdong, 020-81292183
Liping Wei, 020-81292183, gysybgs@126.com
Liping Wei
- Recruiting
The First Affiliated Hospital of Guangdong Medical University
Guangzhou, Guangdong, 510000
Yumin Zhou, (020) 83062114, zhouyumin410@126.com
Nanshan Zhong
- Recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014
Yilan Sun, 0571-87666666, zjsrmyygcp@163.com
Yilan Sun
- Recruiting
The Second Hospital of Anhui Medical Univesity
Hefei, Anhui, 230601
Wei Hu, 13856086475, huwei@ahmu.edu.com
Qian Zhang
- Recruiting
Jiangmen Central Hospital
Jiangmen, Guangdong, 529000
Yanming Huang, 0750-3165500, jmszxyy@jiangmen.gov.cn
Yanming Huang
- Recruiting
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330006
Min Jiang, 0791-86895550, jmjxnc@163.com
Min Jiang
- Recruiting
Qingyuan People's Hospital
Qingyuan, Guangdong
0763-3313033, 2682105044@qq.com
Dongbo Tian
- Recruiting
The First People's Hospital of Xinxiang City
Xinxiang, Henan, 453000
Rongkai Li, 0373-3665025, lirongkai@163.com
Rongkai Li
- Recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221002
Bi Chen, 0376-85806000, chenbi207@126.com
Bi Chen
- Recruiting
Yichang Central People's Hospital
Yichang, Hubei, 443000
Xiaoqi Xiong, 0717-6483495, glacierxq@126.com
Xiaoqi Xiong
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 Obstructive Pulmonary Disease (COPD)
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 Obstructive Pulmonary Disease (COPD).
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 (two repeated doses in patients with COPD, MAD in patients part)
- Being tested
- BBT002, Placebo
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
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 | Two doses of BBT002 will be administered in patients with COPD. 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 | Two doses of Placebo will be administered in patients with COPD. 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 adverse events (AEs) graded per CTCAE v5.0.
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 vital sign measurements following dose administration.
Blood pressure and heart rate 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 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 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- 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- 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- 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 posted17 Dec 2025
- Study start5 Sep 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 68 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
- NCT07288554
- Sponsor's protocol ID
- BBT002-002
- Status last verified
- Jul 2026
- First submitted
- 16 Dec 2025
- 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 Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT07288554
- Acronym / sponsor ID
- BBT002-002
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Bambusa TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 5 Sep 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 17 Dec 2025 (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 Obstructive Pulmonary Disease (COPD).
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 (two repeated doses in patients with COPD, 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: BBT002Two doses of BBT002 will be administered in patients with COPD. |
| 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: PlaceboTwo doses of Placebo will be administered in patients with COPD. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age of 18-65 years (HVs), 35-75 years (patients)
- Body mass index between 18-32 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 adverse events (AEs) graded per CTCAE v5.0.
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 vital sign measurements following dose administration.
Time frame: Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration
Blood pressure and heart rate will be assessed.
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 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- 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- Area under the curve (AUC)
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.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BBT002 in people with Chronic Obstructive Pulmonary Disease (COPD), run by Bambusa Therapeutics at 11 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 9 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 11 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 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.
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, 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.