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

PHASE1RECRUITING

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 details:

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.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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

Exclusion criteria

  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.
  9. Skin diseases other than atopic dermatitis, significant tattoos, or scarring.
  10. Receipt of immunoglobulin or blood products within 30 days.
  11. Atopic dermatitis with ocular symptoms or chronic ocular steroid use.
  12. Chronic pruritus from conditions other than atopic dermatitis.
  13. Acute/treated infections or chronic skin infections.
  14. Current use of sedating antihistamines or corticosteroids.

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

TREATMENT

phase

Phase

    PHASE1

trial

Study ID

NCT06808477

Intervention or treatment

DRUG: BBT001

DRUG: Placebo

Conditions

  • Atopic Dermatitis

  • Condition: Atopic Dermatitis

  • DRUG: BBT001 and other drugs

  • Perth, Western Australia, Australia

  • Sponsor: Bambusa Therapeutics

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Are you running this trial?

If you're a clinic or sponsor, you can claim this study

Research sites nearby

Closest Location:

Linear Clinical Research

Select from list below to view details:

  • Linear Clinical Research

    Perth, Western Australia, Australia

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Who is running the clinical trial?

BT

Bambusa Therapeutics

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?

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Part A Single Ascending Dose BBT001
  • A single dose of BBT001 will be administered in healthy volunteers
Drug: BBT001
    EXPERIMENTAL: Part B Multiple Ascending Dose BBT001
    • Multiple doses of BBT001 will be administered in healthy volunteers.
    Drug: BBT001
      EXPERIMENTAL: Part C Multiple Ascending Dose BBT001
      • Multiple doses of BBT001 will be administered in patients with atopic dermatitis.
      Drug: BBT001
        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
          • Multiple doses of Placebo will be administered in healthy volunteers.
          Drug: Placebo
            PLACEBO_COMPARATOR: Part C Multiple Ascending Dose Placebo
            • Multiple doses of Placebo will be administered in patients with atopic dermatitis.
            Drug: Placebo
              ACTIVE_COMPARATOR: Part D Single Ascending Dose BBT001
              • A single dose of BBT001 will be administered in healthy volunteers
              Drug: BBT001
                PLACEBO_COMPARATOR: Part D Single Ascending Dose Placebo
                • A single dose of placebo will be administered in healthy volunteers
                Drug: Placebo
                  ACTIVE_COMPARATOR: Part E Multiple Ascending Dose BBT001 - Dose Level 1
                  • Multiple doses of BBT001 will be administered in patients with atopic dermatitis.
                  Drug: BBT001
                    PLACEBO_COMPARATOR: Part E Multiple Ascending Dose Placebo
                    • Multiple doses of placebo will be administered in patients with atopic dermatitis.
                    Drug: Placebo
                      ACTIVE_COMPARATOR: Part E Multiple Ascending Dose BBT001 - Dose Level 2
                      • Multiple doses of BBT001 will be administered in patients with atopic dermatitis
                      Drug: BBT001

                        What is the study measuring?

                        Primary Outcome

                        MeasureDescriptionTime Frame
                        Number of participants with adverse events following single and multiple administration of BBT001Incidence, relatedness, and severity of adverse events graded per NCI CTCAE v5.0.Part A- Up to Day 141; Part B and C- Up to Day 169 post first dose administration
                        Number of participants with change in serum blood parametersLaboratory assessments include hematology, blood chemistry and coagulation testPart A- Up to Day 141; Part B and C- 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.Part A- Up to Day 141; Part B and C- Up to Day 169 post first dose administration
                        Number of participants with change in physical examination following treatment administration.Physical examination will be assessed.Part A- Up to Day 141; Part B and C- Up to Day 169 post first dose administration

                        Secondary Outcome

                        MeasureDescriptionTime Frame
                        Pharmacokinetics parameters- maximum observed Concentration (Cmax)Maximum observed concentration of the study drug in serum will be analyzed for all subjectsAt 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 subjectsAt 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 subjectsAt 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 subjectsAt 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 subjectsAt 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 subjectsAt 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 subjectsAt specified timepoints pre-dose and up to 169 days post first dose administration
                        Are you running this trial?If you're a clinic or sponsor, you can claim this study.
                        Claim this trial

                        References

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

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