Atopic DermatitisPhase 1NCT06808477
A Study of BBT001 in Healthy Volunteers (HVs) and in Adult Patients With Atopic Dermatitis (AD)
A Phase 1 study testing BBT001 in people with Atopic Dermatitis, run by Bambusa Therapeutics at 14 sites in 4 countries.
Trial summary
This is a Phase 1, randomized, blinded, placebo controlled, single-ascending dose (SAD) and multiple-ascending dose (MAD) 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 72 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
- 237 participants
- Where
- 14 sitesin 4 countries
- Study dates
- 27 Feb 2025to 28 Feb 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 72 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
- Age of 18-65 years.
- Body mass index of 18 to 32 kg/m², weight capped at 120 kg.
Show all 14Show fewer
- No clinically significant abnormalities or history of relevant diseases.
- Age of 18-72 years.
- Body mass index ≥16 kg/m², weight capped at 125 kg.
- 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.
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.
Show all 15Show fewer
- Donated >500mL blood within 2 months of screening.
- History of severe allergic reactions or hypersensitivity.
- 1. History of atopic dermatitis
- 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
14 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
14 sites in 4 countries
New Zealand5 sites, 4 recruiting
- Recruiting
Optimal Clinical Trials Ltd - Christchurch
Christchurch
- Recruiting
Optimal Clinical Trials Central Auckland
Grafton, Auckland, 1010
Arna Letica
- Withdrawn
Aotearoa Clinical Trials
Otahuhu, Auckland, 2025
- Recruiting
Pacific Clinical Research Network (PCRN) - Auckland
Takapuna, Auckland, 0622
Paul Hamilton
- Recruiting
Pacific Clinical Research Network (PCRN) Wellington
Upper Hutt, 5018
Tim Humphrey
Poland4 sites, 4 recruiting
- Recruiting
Wojewódzki Specjalistyczny Szpital im. Dr. Wł. Biegańskiego w Łodzi
Lodz, 91-347
- Recruiting
Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie
Rzeszów, 35-055
- Recruiting
Państwowy Instytut Medyczny MSWiA
Warsaw, 02-507
- Recruiting
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska
Wroclaw, 50-566
United States3 sites, 3 recruiting
- Recruiting
First OC Dermatology
Irvine, California, 92614
- Recruiting
OptiSkin Medical
New York, New York, 10128
- Recruiting
Equity Medical, LLC
The Bronx, New York, 10455
Australia2 sites, 1 recruiting
- Recruiting
Fremantle Dermatology
Fremantle, Western Australia, 6160
- Completed
Linear Clinical Research
Perth, Western Australia, 6009
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 Adult Patients With AD
This is a Phase 1, randomized, blinded, placebo controlled, single-ascending dose (SAD) and multiple-ascending dose (MAD) study of BBT001 in healthy volunteers (HVs) and adult patients with moderate to severe Atopic Dermatitis (AD).
Read the detailed description
This study a is a randomized, double-blinded, placebo-controlled single (SAD) and multiple-ascending dose (MAD) study to evaluate safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics, and exploratory clinical activity of BBT001 in healthy volunteers (HVs) and in adult patients with atopic dermatitis. BBT001 is a drug candidate being developed for the treatment of atopic dermatitis.
- 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 Single Ascending Dose BBT001 | Experimental | A single dose of BBT001 will be administered in healthy volunteers Receives: Drug: BBT001 |
| Part B Multiple Ascending Dose BBT001 | Experimental | Multiple doses of BBT001 will be administered in healthy volunteers. Receives: Drug: BBT001 |
| Part C Multiple Ascending Dose BBT001 | Experimental | Multiple doses of BBT001 will be administered in patients with atopic dermatitis. Receives: Drug: BBT001 |
| 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 | Multiple doses of Placebo will be administered in healthy volunteers. Receives: Drug: Placebo |
| Part C Multiple Ascending Dose Placebo | Placebo comparator | Multiple doses of Placebo will be administered in patients with atopic dermatitis. Receives: Drug: Placebo |
| Part D Single Ascending Dose BBT001 | Active comparator | A single dose of BBT001 will be administered in healthy volunteers Receives: Drug: BBT001 |
| Part D Single Ascending Dose Placebo | Placebo comparator | A single dose of placebo will be administered in healthy volunteers Receives: Drug: Placebo |
| Part E Multiple Ascending Dose BBT001 - Dose Level 1 | Active comparator | Multiple doses of BBT001 will be administered in patients with atopic dermatitis. Receives: Drug: BBT001 |
| Part E Multiple Ascending Dose Placebo | Placebo comparator | Multiple doses of placebo will be administered in patients with atopic dermatitis. Receives: Drug: Placebo |
| Part E Multiple Ascending Dose BBT001 - Dose Level 2 | Active comparator | Multiple doses of BBT001 will be administered in patients with atopic dermatitis Receives: Drug: BBT001 |
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: Parts A and D - Up to Day 141; Parts B, C, and E - 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: Parts A and D - Up to Day 141; Parts B, C, and E - 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: Parts A and D - Up to Day 141; Parts B, C, and E - 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: Parts A and D - Up to Day 141; Parts B, C, and E - 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: Parts A and D - Up to Day 141; Parts B, C, and E - 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 posted5 Feb 2025
- Study start27 Feb 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 237 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bambusa Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lisa Li, Study director, Bambusa Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06808477
- Sponsor's protocol ID
- BBT001-001
- Status last verified
- Sep 2026
- First submitted
- 30 Jan 2025
- Last updated
- 29 Sep 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 29 Sep 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 Adult Patients With AD
- ClinicalTrials.gov ID
- NCT06808477
- Acronym / sponsor ID
- BBT001-001
- Conditions
- Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 237 participants (estimated)
- Lead sponsor
- Bambusa TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 5 Feb 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) and multiple-ascending dose (MAD) study of BBT001 in healthy volunteers (HVs) and adult patients with moderate to severe Atopic Dermatitis (AD).
Detailed description
This study a is a randomized, double-blinded, placebo-controlled single (SAD) and multiple-ascending dose (MAD) study to evaluate safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics, and exploratory clinical activity of BBT001 in healthy volunteers (HVs) and in adult patients with atopic dermatitis. BBT001 is a drug candidate being developed for the treatment of atopic dermatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Part A Single Ascending Dose BBT001 | Experimental | Drug: BBT001A single dose of BBT001 will be administered in healthy volunteers |
| Part B Multiple Ascending Dose BBT001 | Experimental | Drug: BBT001Multiple doses of BBT001 will be administered in healthy volunteers. |
| Part C Multiple Ascending Dose BBT001 | Experimental | Drug: BBT001Multiple doses of BBT001 will be administered in patients with atopic dermatitis. |
| 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: PlaceboMultiple doses of Placebo will be administered in healthy volunteers. |
| Part C Multiple Ascending Dose Placebo | Placebo comparator | Drug: PlaceboMultiple doses of Placebo will be administered in patients with atopic dermatitis. |
| Part D Single Ascending Dose BBT001 | Active comparator | Drug: BBT001A single dose of BBT001 will be administered in healthy volunteers |
| Part D Single Ascending Dose Placebo | Placebo comparator | Drug: PlaceboA single dose of placebo will be administered in healthy volunteers |
| Part E Multiple Ascending Dose BBT001 - Dose Level 1 | Active comparator | Drug: BBT001Multiple doses of BBT001 will be administered in patients with atopic dermatitis. |
| Part E Multiple Ascending Dose Placebo | Placebo comparator | Drug: PlaceboMultiple doses of placebo will be administered in patients with atopic dermatitis. |
| Part E Multiple Ascending Dose BBT001 - Dose Level 2 | Active comparator | Drug: BBT001Multiple doses of BBT001 will be administered in patients with atopic dermatitis |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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).
- Age of 18-65 years.
Key exclusion criteria (15 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 Single Ascending Dose BBT001, Part B Multiple Ascending Dose BBT001, Part C Multiple Ascending Dose BBT001, Part D Single Ascending Dose BBT001, Part E Multiple Ascending Dose BBT001 - Dose Level 1, Part E Multiple Ascending Dose BBT001 - Dose Level 2 |
| PlaceboPlacebo will be administered | Drug | Part A Single Ascending Dose Placebo, Part B Multiple Ascending Dose Placebo, Part C Multiple Ascending Dose Placebo, Part D Single Ascending Dose Placebo, Part E Multiple Ascending Dose Placebo |
Primary outcome
Number of participants with adverse events following single and multiple administration of BBT001
Time frame: Parts A and D - Up to Day 141; Parts B, C, and E - 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 serum blood parameters
Time frame: Parts A and D - Up to Day 141; Parts B, C, and E - Up to Day 169 post first dose administration
Laboratory assessments include hematology, blood chemistry and coagulation test
Number of participants with change in vital sign measurements following treatment administration.
Time frame: Parts A and D - Up to Day 141; Parts B, C, and E - 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 treatment administration.
Time frame: Parts A and D - Up to Day 141; Parts B, C, and E - 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: Parts A and D - Up to Day 141; Parts B, C, and E - Up to Day 169 post first dose administration
12-lead ECG 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 29 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Atopic Dermatitis
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
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.
Lisa Li study director
Bambusa Therapeutics, Inc.
14 sites in 4 countries: 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 14 sites in 4 countries.
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 15 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 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in New Zealand, Poland, United States, Australia. 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 Lisa Li (+1 617-848-6188, Lisa.Li@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: Parts A and D - Up to Day 141; Parts B, C, and E - 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 29 Sep 2026.