A Study of BBT001 in Healthy Volunteers (HVs) and in Adult Patients With Atopic Dermatitis (AD)

November 13, 2025 updated by: Bambusa Therapeutics

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 Patients

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study consists of five parts:

  • Part A (single dose of IV administration in HVs in sequential ascending dose cohorts, SAD IV in HVs part)
  • Part B (3 repeat doses of IV administration in HVs in sequential ascending dose cohorts, multiple ascending dose (MAD) IV in HVs part)
  • Part C (3 repeat doses in participants with moderate to severe AD, MAD IV in patients part)
  • Part D (single dose of SC administration in HVs in sequential ascending dose cohorts, SAD SC in HVs part)
  • Part E (4 repeat doses in participants with moderate to severe AD, MAD SC in patients part)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
198

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • Western Australia
      • Perth, Western Australia, Australia, 6009
        • Recruiting
        • Linear Clinical Research
        • Contact:
          • Peter Schrader, Dr
  • New Zealand
      • Upper Hutt, New Zealand, 5018
        • Recruiting
        • Pacific Clinical Research Network (PCRN) Wellington
        • Contact:
          • Tim Humphrey
    • Auckland
      • Grafton, Auckland, New Zealand, 1010
        • Recruiting
        • Optimal Clinical Trials Central Auckland
        • Contact:
          • Arna Letica
      • Otahuhu, Auckland, New Zealand, 2025
        • Recruiting
        • Aotearoa Clinical Trials
        • Contact:
          • Cheng Huang
      • Takapuna, Auckland, New Zealand, 0622
        • Recruiting
        • Pacific Clinical Research Network (PCRN) - Auckland
        • Contact:
          • Paul Hamilton
    • Christchurch
      • Christchurch Central City, Christchurch, New Zealand
        • Not yet recruiting
        • Optimal Clinical Trials Ltd - Christchurch
  • United States
    • New York
      • The Bronx, New York, United States, 10455
        • Not yet recruiting
        • Equity Medical, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Key Inclusion Criteria (Part A, B, C, D)

  1. Age of 18-65 years.
  2. Body mass index between 18-32 kg/m², capped at 120 kg.
  3. Negative pregnancy tests for women of childbearing potential.
  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.
  6. Adequate contraception use (for men and women of childbearing potential).
  7. No clinically significant abnormalities or history of relevant diseases.

Key Inclusion Criteria (Parts C and E only)

  1. Must have dermatologist-confirmed chronic atopic dermatitis (≥12 months). Inadequate response to topical treatments or where they are medically inadvisable.
  2. Moderate to severe atopic dermatitis
  3. Validated investigator's global assessment for atopic dermatitis (vIGA-ADTM) score ≥3
  4. Atopic lesions cover ≥10% of body surface area (BSA)
  5. Average peak pruritus numeric rating scale (PP-NRS) score ≥4 in the 7 days before randomization.

Key Exclusion Criteria for (Part A, B, C, D)

  1. 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.
  2. History of major metabolic, dermatological, liver, kidney, hematological, or other significant disorders.
  3. Clinically relevant abnormal lab results, including low blood counts, liver issues, or abnormal kidney function.
  4. Positive drug/alcohol tests or abnormal vital signs at screening or Day -1.
  5. Abnormal Electrocardiogram (ECG) findings
  6. History of drug/alcohol abuse in the past 2 years.
  7. Donated >500mL blood within 2 months of screening.
  8. History of severe allergic reactions or hypersensitivity.

Key Exclusion Criteria for (Parts C and E only)

  1. Skin diseases other than atopic dermatitis, significant tattoos, or scarring.
  2. Receipt of immunoglobulin or blood products within 30 days.
  3. Atopic dermatitis with ocular symptoms or chronic ocular steroid use.
  4. Chronic pruritus from conditions other than atopic dermatitis.
  5. Acute/treated infections or chronic skin infections.
  6. Current use of sedating antihistamines or corticosteroids.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part A Single Ascending Dose BBT001 IV
A single dose of BBT001 will be administered in healthy volunteers
Drug: BBT001
BBT001 will be administered
Experimental: Part B Multiple Ascending Dose BBT001 IV
Three doses of BBT001 will be administered in healthy volunteers.
Drug: BBT001
BBT001 will be administered
Experimental: Part C Multiple Ascending Dose BBT001 IV
Three doses of BBT001 will be administered in patients with atopic dermatitis.
Drug: BBT001
BBT001 will be administered
Placebo Comparator: Part A Single Ascending Dose Placebo IV
A single dose of Placebo will be administered in healthy volunteers
Drug: Placebo
Placebo will be administered
Placebo Comparator: Part B Multiple Ascending Dose Placebo IV
Three doses of Placebo will be administered in healthy volunteers.
Drug: Placebo
Placebo will be administered
Placebo Comparator: Part C Multiple Ascending Dose Placebo IV
Three doses of Placebo will be administered in patients with atopic dermatitis.
Drug: Placebo
Placebo will be administered
Active Comparator: Part D Single Ascending Dose BBT001 SC
A single dose of BBT001 will be administered in healthy volunteers
Drug: BBT001
BBT001 will be administered
Placebo Comparator: Part D Single Ascending Dose Placebo SC
A single dose of placebo will be administered in healthy volunteers
Drug: Placebo
Placebo will be administered
Active Comparator: Part E Multiple Ascending Dose BBT001 SC - Dose Level 1
Four doses of BBT001 will be administered in patients with atopic dermatitis.
Drug: BBT001
BBT001 will be administered
Placebo Comparator: Part E Multiple Ascending Dose Placebo SC
Four doses of placebo will be administered in patients with atopic dermatitis.
Drug: Placebo
Placebo will be administered
Active Comparator: Part E Multiple Ascending Dose BBT001 SC - Dose Level 2
Four doses of BBT001 will be administered in patients with atopic dermatitis.
Drug: BBT001
BBT001 will be administered

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events following single and multiple administration of BBT001
Time Frame: Part A and D - Up to Day 141; Part 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.
Part A and D - Up to Day 141; Part B, C and E - Up to Day 169 post first dose administration
Number of participants with change in serum blood parameters
Time Frame: Part A and D - Up to Day 141; Part B, C and E - Up to Day 169 post first dose administration
Laboratory assessments include hematology, blood chemistry and coagulation test
Part A and D - Up to Day 141; Part B, C and E - Up to Day 169 post first dose administration
Number of participants with change in vital sign measurements following treatment administration.
Time Frame: Part A and D - Up to Day 141; Part B, C and E - Up to Day 169 post first dose administration
Blood pressure and heart rate will be assessed.
Part A and D - Up to Day 141; Part B, C and E - Up to Day 169 post first dose administration
Number of participants with change in physical examination following treatment administration.
Time Frame: Part A and D - Up to Day 141; Part B, C and E - Up to Day 169 post first dose administration
Physical examination will be assessed.
Part A and D - Up to Day 141; Part B, C and E - Up to Day 169 post first dose administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetics parameters- maximum observed Concentration (Cmax)
Time Frame: At specified timepoints pre-dose and up to 169 days post first dose administration
Maximum observed concentration of the study drug in serum will be analyzed for all subjects
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
Serum PK Tmax will be analyzed for all subjects
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
Area under the curve of the study drug in serum will be analyzed for all subjects
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
Volume of distribution of the study drug in serum will be analyzed for all subjects
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
Total clearance of the study drug in serum will be analyzed for all subjects
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
Elimination half-life of the study drug in serum will be analyzed for all subjects
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
Serum Anti-Drug Antibodies will be analyzed for all subjects
At specified timepoints pre-dose and up to 169 days post first dose administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bambusa Therapeutics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Lisa Li, Bambusa Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 27, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 21, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 6, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BBT001-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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