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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBambusa Therapeutics

About this trial

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).

Eligibility criteria

Qualifiers

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.

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

Treatments tested in this trial

  • BBT001
  • Placebo

Treatment groups

63 Participants
are divided into 4 treatment groups

Sponsors and collaborators