Atopic DermatitisPhase 1NCT07239947
A Study of BBT001 in Healthy Volunteers (HVs) and in Adult Patients With Moderate to Severe Atopic Dermatitis (AD)
A Phase 1 study testing BBT001 in people with Atopic Dermatitis, run by Bambusa Therapeutics at 10 sites in China.
Trial summary
This is a Phase 1, randomized, blinded, placebo controlled, single ascending dose (SAD) study of BBT001 in healthy volunteers (HVs) and adult patients with moderate to severe Atopic Dermatitis (AD). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- BBT001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 10 sitesChina
- Study dates
- 9 Aug 2025to 30 Jun 2028
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age of 18-65 years.
- Body mass index between 18-28 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.
- Must have dermatologist-confirmed chronic atopic dermatitis (≥12 months). Inadequate response to topical treatments or where they are medically inadvisable.
- Moderate to severe atopic dermatitis
- Validated investigator's global assessment for atopic dermatitis (vIGA-ADTM) score ≥3
- Atopic lesions cover ≥10% of body surface area (BSA)
- Average peak pruritus numeric rating scale (PP-NRS) score ≥4 in the 7 days before randomization.
- Eczema Area and Severity Index (EASI) score ≥16 at screening and randomization visits.
- （for biologic/JAKi experienced subjects) Patients with prior systemic exposure to the following agents are eligible for enrollment: biologics targeting IL-4/IL-13 or IL-31 pathway or JAK inhibitors.
Who cannot join
- Significant health issues, such as: diabetes, positive tests for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B surface antigen (HBsAg), 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 issues, 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.
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- Donated >500mL blood within 2 months of screening.
- History of severe allergic reactions or hypersensitivity.
- Skin diseases other than atopic dermatitis, significant tattoos, or scarring.
- Receipt of immunoglobulin or blood products within 30 days.
- Atopic dermatitis with ocular symptoms or chronic ocular steroid use.
- Chronic pruritus from conditions other than atopic dermatitis.
- Acute/treated infections or chronic skin infections.
- Current use of sedating antihistamines or corticosteroids.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
China10 sites, 10 recruiting
- Not yet recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100032
Jianzhong Zhang, Principle Investigator, 010-88324516, rmzjz@126.com
- Not yet recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
Yunsheng Liang, Principle Investigator, 0553-2871846, yunshenglianggcp@163.com
- Not yet recruiting
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, 510440
Bin Yang, Principle Investigator, 020-8306 8888, yangbin101@hotmail.com
- Recruiting
The Second Hospital of Anhui Medical Univesity
Hefei, Anhui, 230601
Wei Hu, Principle Investigator, 0551-63869420, hwgcp@ayefy.com
Chunjun Yang
- Not yet recruiting
Shandong Provincial Hospital for Skin Diseases
Jinan, Shandong, 250011
Furen Zhang, Principle Investigator, 0531-87298882, zhangfuren@hotmail.com
- Not yet recruiting
Jiangxi Provincial Dermatology Hospital
Nanchang, Jiangxi, 330000
Guohong Hu, Principle Investigator, 0791-85214720, 20079850@qq.com
- Not yet recruiting
Shanghai Dermatology Hospital
Shanghai, Shanghai Municipality, 200050
Yangfeng Ding, 021-61833000, dingyangfeng@aliyun.com
- Not yet recruiting
The Second Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, 241001
Ruzhi Zhang, Principle Investigator, 0553-2871846, zhangruzhi628@163.com
- Not yet recruiting
Wuxi Second People's Hospital
Wuxi, Jiangsu, 214002
Xiaoli Zhang, Principle Investigator, 0510-68562222, zxl415@163.com
- Not yet recruiting
Jiangsu University Affiliated Hospital
Zhenjiang, Jiangsu, 212001
Yumei Li, Principle Investigator, 0511-85026832, l.yumei@aliyun.com
About this study
Official title: A Randomized, Blinded, Placebo-controlled, Single- and Multiple-ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Clinical Activity of BBT001 in HVs and AD Patient
This is a Phase 1, randomized, blinded, placebo controlled, single ascending dose (SAD) study of BBT001 in healthy volunteers (HVs) and adult patients with moderate to severe Atopic Dermatitis (AD).
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 (seven repeated doses in patients with moderate to severe AD, multiple ascending Dose in patients part)
- Conditions
- Atopic Dermatitis
- Being tested
- BBT001, Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BBT001Drug
BBT001 will be administered
PlaceboDrug
Placebo will be administered
| Study group | Role | What they receive |
|---|---|---|
| Part A -BBT001(Single Ascending Dose) | Experimental | A single dose of BBT001 will be administered in healthy volunteers Receives: Drug: BBT001 |
| Part A- Placebo(Single Ascending Dose) | Experimental | A single dose of Placebo will be administered in healthy volunteers Receives: Drug: Placebo |
| Part B- BBT001(Multiple Ascending Dose) | Experimental | Seven repeat doses of BBT001 will be administered in patients with moderate to severe atopic dermatitis Receives: Drug: BBT001 |
| Part B -Placebo (Multiple Ascending Dose)) | Experimental | Seven repeat doses of Placebo will be administered in patients with moderate to severe atopic dermatitis 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 BBT001
Incidence, relatedness, and severity of adverse events graded per NCI 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 vital sign measurements following treatment 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 serum blood parameters.
Laboratory assessments include hematology, blood chemistry and coagulation test
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 treatment 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 electrocardiogram (ECG) results measurements following treatment administration.
12-lead ECG will be tested at individual sites using sites' equipment and will be assessed.
Measured: Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration
Secondary outcomes (7)
Pharmacokinetics 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.
Pharmacokinetics 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
Pharmacokinetics 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
Pharmacokinetics 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
Pharmacokinetics 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
Pharmacokinetics 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 BBT001 is measured as the number and percentage of subjects who develop Anti-Drug Antibodies (ADA).
Serum Anti-Drug Antibodies will be analyzed for all subjects
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 posted20 Nov 2025
- Study start9 Aug 2025
- 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 Atopic DermatitisStudies 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
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bambusa Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tracy Ji, Study director, Bambusa (Beijing) Therapeutics Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07239947
- Sponsor's protocol ID
- BBT001-002
- Status last verified
- Jul 2026
- First submitted
- 28 Sep 2025
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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, Blinded, Placebo-controlled, Single- and Multiple-ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Clinical Activity of BBT001 in HVs and AD Patient
- ClinicalTrials.gov ID
- NCT07239947
- Acronym / sponsor ID
- BBT001-002
- Conditions
- Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Bambusa TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 9 Aug 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 20 Nov 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 is a Phase 1, randomized, blinded, placebo controlled, single ascending dose (SAD) study of BBT001 in healthy volunteers (HVs) and adult patients with moderate to severe Atopic Dermatitis (AD).
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 (seven repeated doses in patients with moderate to severe AD, multiple ascending Dose in patients part)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A -BBT001(Single Ascending Dose) | Experimental | Drug: BBT001A single dose of BBT001 will be administered in healthy volunteers |
| Part A- Placebo(Single Ascending Dose) | Experimental | Drug: PlaceboA single dose of Placebo will be administered in healthy volunteers |
| Part B- BBT001(Multiple Ascending Dose) | Experimental | Drug: BBT001Seven repeat doses of BBT001 will be administered in patients with moderate to severe atopic dermatitis |
| Part B -Placebo (Multiple Ascending Dose)) | Experimental | Drug: PlaceboSeven repeat doses of Placebo will be administered in patients with moderate to severe atopic dermatitis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age of 18-65 years.
- Body mass index between 18-28 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 (14 listed)
- Significant health issues, such as: diabetes, positive tests for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B surface antigen (HBsAg), 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 issues, or abnormal kidney function.
- Positive drug/alcohol tests or abnormal vital signs at screening or Day -1.
- Abnormal Electrocardiogram (ECG) findings
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 |
|---|---|---|
| BBT001BBT001 will be administered | Drug | Part A -BBT001(Single Ascending Dose), Part B- BBT001(Multiple Ascending Dose) |
| PlaceboPlacebo will be administered | Drug | Part A- Placebo(Single Ascending Dose), Part B -Placebo (Multiple Ascending Dose)) |
Primary outcome
Number of participants with adverse events following single and multiple administration of BBT001
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 graded per NCI CTCAE v5.0.
Number of participants with change in vital sign measurements following treatment 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 serum blood parameters.
Time frame: Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration
Laboratory assessments include hematology, blood chemistry and coagulation test
Number of participants with change in physical examination following treatment 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 electrocardiogram (ECG) results measurements following treatment administration.
Time frame: Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration
12-lead ECG will be tested at individual sites using sites' equipment and will be assessed.
7 secondary outcomes
Pharmacokinetics parameters- maximum observed Concentration (Cmax)
Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration.
Pharmacokinetics parameters- Time for maximum observed Concentration (Tmax)
Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration
Pharmacokinetics parameters- Area under the curve (AUC)
Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration
Pharmacokinetics parameters- Volume of distribution (Vz)
Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration
Pharmacokinetics parameters- Total clearance (CL)
Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration
Pharmacokinetics 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 BBT001 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.
- Individual participant dataSharing planned: No
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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.
Tracy Ji study director
Bambusa (Beijing) Therapeutics Co., Ltd.
10 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 BBT001 in people with Atopic Dermatitis, run by Bambusa Therapeutics at 10 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 14 inclusion and 14 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 10 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. 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 (+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 BBT001 (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.