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
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
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)
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
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 a…
Interventions
- DrugBBT001
BBT001 will be administered
- DrugPlacebo
Placebo will be administered
Locations (7)
- Equity Medical, LLCThe Bronx, New York
- Linear Clinical ResearchPerth, Western Australia
- Optimal Clinical Trials Central AucklandGrafton, Auckland
- Aotearoa Clinical TrialsOtahuhu, Auckland
- Pacific Clinical Research Network (PCRN) - AucklandTakapuna, Auckland
- Optimal Clinical Trials Ltd - ChristchurchChristchurch Central City, Christchurch