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

ConditionAtopic Dermatitis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-72
SponsorBambusa Therapeutics

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • BBT001

    Drug

    BBT001 will be administered

  • Placebo

    Drug

    Placebo will be administered

Treatment groups

237 Participants
are divided into 11 treatment groups

11

Treatment groups

See each treatment group below.

Group A: Part A Single Ascending Dose BBT001Experimental treatment 1 intervention
Group B: Part B Multiple Ascending Dose BBT001Experimental treatment 1 intervention
Group C: Part C Multiple Ascending Dose BBT001Experimental treatment 1 intervention
Group D: Part A Single Ascending Dose PlaceboPlacebo comparator 1 intervention
Group E: Part B Multiple Ascending Dose PlaceboPlacebo comparator 1 intervention
Group F: Part C Multiple Ascending Dose PlaceboPlacebo comparator 1 intervention
Group G: Part D Single Ascending Dose BBT001Active comparator 1 intervention
Group H: Part D Single Ascending Dose PlaceboPlacebo comparator 1 intervention
Group I: Part E Multiple Ascending Dose BBT001 - Dose Level 1Active comparator 1 intervention
Group J: Part E Multiple Ascending Dose PlaceboPlacebo comparator 1 intervention
Group K: Part E Multiple Ascending Dose BBT001 - Dose Level 2Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Parts A and D - Up to Day 141; Parts B, C, and E - Up to Day 169 post first dose administration
2

Number of participants with change in serum blood parameters

Laboratory assessments include hematology, blood chemistry and coagulation test

Time frame
Parts A and D - Up to Day 141; Parts B, C, and E - Up to Day 169 post first dose administration
3

Number of participants with change in vital sign measurements following treatment administration.

Blood pressure and heart rate will be assessed.

Time frame
Parts A and D - Up to Day 141; Parts B, C, and E - Up to Day 169 post first dose administration
4

Number of participants with change in physical examination following treatment administration.

Physical examination will be assessed.

Time frame
Parts A and D - Up to Day 141; Parts B, C, and E - Up to Day 169 post first dose administration

Secondary outcomes

1

Pharmacokinetics parameters - maximum observed Concentration (Cmax)

Maximum observed concentration of the study drug in serum will be analyzed for all subjects

Time frame
At specified timepoints pre-dose and up to 169 days post first dose administration
2

Pharmacokinetics parameters - Time for maximum observed Concentration (Tmax)

Serum PK Tmax will be analyzed for all subjects

Time frame
At specified timepoints pre-dose and up to 169 days post first dose administration
3

Pharmacokinetics parameters - Area under the curve (AUC)

Area under the curve of the study drug in serum will be analyzed for all subjects

Time frame
At specified timepoints pre-dose and up to 169 days post first dose administration
4

Pharmacokinetics parameters - Volume of distribution (Vz)

Volume of distribution of the study drug in serum will be analyzed for all subjects

Time frame
At specified timepoints pre-dose and up to 169 days post first dose administration

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bambusa Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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