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
Bambusa Therapeutics
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).
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.
Eligibility
- Age range
- 18–72 years
- Sex
- All
- Healthy volunteers
- Yes
Key Inclusion Criteria 1. Negative pregnancy tests for women of childbearing potential. 2. Willingness to refrain from alcohol consumption for 24 hours prior to each study visit. 3. Non-smokers, healthy current smokers (≤5 cigarettes/day), or ex-smokers. 4. Adequate contraception use (for men and women of childbearing potential). Key Inclusion Criteria (Parts A, B, and D) 1. Age of 18-65 years. 2. Body mass index of 18 to 32 kg/m², weight capped at 120 kg. 3. No clinically significant abnormalities or history of relevant diseases. Key Inclusion Criteria (Parts C and E only) 1. Age of 18-7…
Interventions
- DrugBBT001
BBT001 will be administered
- DrugPlacebo
Placebo will be administered
Locations (14)
- First OC DermatologyIrvine, California
- OptiSkin MedicalNew York, New York
- Equity Medical, LLCThe Bronx, New York
- Fremantle DermatologyFremantle, Western Australia
- Linear Clinical ResearchPerth, Western Australia
- Optimal Clinical Trials Central AucklandGrafton, Auckland