A Study of BBT001 in Healthy Volunteers (HVs) and in Adult Patients With Atopic Dermatitis (AD)
- Registration Number
- NCT06808477
- Lead Sponsor
- Bambusa Therapeutics
- Brief 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).
- Detailed 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)
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 198
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part A Single Ascending Dose BBT001 IV BBT001 A single dose of BBT001 will be administered in healthy volunteers Part B Multiple Ascending Dose BBT001 IV BBT001 Three doses of BBT001 will be administered in healthy volunteers. Part C Multiple Ascending Dose BBT001 IV BBT001 Three doses of BBT001 will be administered in patients with atopic dermatitis. Part A Single Ascending Dose Placebo IV Placebo A single dose of Placebo will be administered in healthy volunteers Part B Multiple Ascending Dose Placebo IV Placebo Three doses of Placebo will be administered in healthy volunteers. Part C Multiple Ascending Dose Placebo IV Placebo Three doses of Placebo will be administered in patients with atopic dermatitis. Part D Single Ascending Dose BBT001 SC BBT001 A single dose of BBT001 will be administered in healthy volunteers Part D Single Ascending Dose Placebo SC Placebo A single dose of placebo will be administered in healthy volunteers Part E Multiple Ascending Dose BBT001 SC - Dose Level 1 BBT001 Four doses of BBT001 will be administered in patients with atopic dermatitis. Part E Multiple Ascending Dose Placebo SC Placebo Four doses of placebo will be administered in patients with atopic dermatitis. Part E Multiple Ascending Dose BBT001 SC - Dose Level 2 BBT001 Four doses of BBT001 will be administered in patients with atopic dermatitis.
- Primary Outcome Measures
Name Time Method Number of participants with adverse events following single and multiple administration of BBT001 Part A and D - Up to Day 141; Part B, C and E - Up to Day 169 post first dose administration Incidence, relatedness, and severity of adverse events graded per NCI CTCAE v5.0.
Number of participants with change in serum blood parameters Part A and D - Up to Day 141; Part B, C and E - Up to Day 169 post first dose administration Laboratory assessments include hematology, blood chemistry and coagulation test
Number of participants with change in vital sign measurements following treatment administration. Part A and D - Up to Day 141; Part B, C and E - Up to Day 169 post first dose administration Blood pressure and heart rate will be assessed.
Number of participants with change in physical examination following treatment administration. Part A and D - Up to Day 141; Part B, C and E - Up to Day 169 post first dose administration Physical examination will be assessed.
- Secondary Outcome Measures
Name Time Method Pharmacokinetics parameters- Area under the curve (AUC) At specified timepoints pre-dose and up to 169 days post first dose administration Area under the curve of the study drug in serum will be analyzed for all subjects
Pharmacokinetics parameters- Time for maximum observed Concentration (Tmax) At specified timepoints pre-dose and up to 169 days post first dose administration Serum PK Tmax will be analyzed for all subjects
Pharmacokinetics parameters- Volume of distribution (Vz) At specified timepoints pre-dose and up to 169 days post first dose administration Volume of distribution of the study drug in serum will be analyzed for all subjects
Pharmacokinetics parameters- maximum observed Concentration (Cmax) At specified timepoints pre-dose and up to 169 days post first dose administration Maximum observed concentration of the study drug in serum will be analyzed for all subjects
Pharmacokinetics parameters- Total clearance (CL) At specified timepoints pre-dose and up to 169 days post first dose administration Total clearance of the study drug in serum will be analyzed for all subjects
The immunogenicity of BBT001 is measured as the number and percentage of subjects who develop Anti-Drug Antibodies (ADA). At specified timepoints pre-dose and up to 169 days post first dose administration Serum Anti-Drug Antibodies will be analyzed for all subjects
Pharmacokinetics parameters- - Elimination Half-life (t1/2). At specified timepoints pre-dose and up to 169 days post first dose administration Elimination half-life of the study drug in serum will be analyzed for all subjects
Related Research Topics
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Trial Locations
- Locations (7)
Equity Medical, LLC
🇺🇸The Bronx, New York, United States
Optimal Clinical Trials Ltd - Christchurch
🇳🇿Christchurch Central City, Christchurch, New Zealand
Linear Clinical Research
🇦🇺Perth, Western Australia, Australia
Optimal Clinical Trials Central Auckland
🇳🇿Grafton, Auckland, New Zealand
Aotearoa Clinical Trials
🇳🇿Otahuhu, Auckland, New Zealand
Pacific Clinical Research Network (PCRN) - Auckland
🇳🇿Takapuna, Auckland, New Zealand
Pacific Clinical Research Network (PCRN) Wellington
🇳🇿Upper Hutt, New Zealand
Equity Medical, LLC🇺🇸The Bronx, New York, United States