Chronic Spontaneous Urticaria
Conditions
Brief summary
This is a Phase IIa, randomized, blinded, placebo controlled,Multiple-Ascending Dose study of BBT001 in adult patients with Chronic Spontaneous Urticaria.
Detailed description
The study consists of below cohorts: Cohort A1 (biologic-naïve): 450 mg BBT001 (n = 8) or placebo (n = 4) Cohort A2 (biologic-experienced): 450 mg BBT001 (n = 8) or placebo (n = 4) Cohort A3 (biologic-naïve) (optional): 900 mg BBT001 (n = 8) or placebo (n = 4) Cohort A4 (biologic-experienced) (optional): 900 mg BBT001 (n = 8) or placebo (n = 4)
Interventions
DRUGBBT001
BBT001 will be administered
DRUGPlacebo
Placebo will be administered
Sponsors
Bambusa Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
key inclusion criteria: 1)Male or female 18 to 75 years (inclusive) of age at time of consent. 2)Capped weight to be no more than 125 kg at screening.3)UAS7\>=16; 4)Patients must have been on daily stable doses of H1-AH;5) Written informed consent obtained from the participant prior to performing any protocol-related procedures. For A2/A4 only: Participants who have received prior treatment with any biological products (e.g., omalizumab or dupilumab) . The last dose≥ 5 half-lives prior to randomization.
Exclusion criteria
key
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events following multiple administration of BBT001 | - Up to Day 183 post first dose administration | Incidence, relatedness, and severity of adverse events graded per NCI CTCAE v6.0. |
| Number of participants with change in vital sign measurements following treatment administration. | Up to Day 183 post first dose administratio | Blood pressure and heart rate will be assessed. |
| Number of participants with change in serum blood parameters. | Up to Day 183 post first dose administration | Laboratory assessments include hematology, blood chemistry and coagulation test |
| Number of participants with change in physical examination following treatment administration | Up to Day 183 post first dose administration | Physical examination will be assessed |
| Number of participants with change in 12-lead electrocardiogram (ECG) results measurements following treatment administration. | Up to Day 183 post first dose administration | 12-lead ECG will be tested at individual sites using sites' equipment and will be assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics parameters- Time for maximum observed Concentration (Tmax) | At specified timepoints pre-dose and up to 183 days post first dose administration] | Serum PK Tmax will be analyzed for all subjects |
| Pharmacokinetics parameters- Area under the curve (AUC) | At specified timepoints pre-dose and up to 183 days post first dose administration | Area under the curve of the study drug in serum will be analyzed for all subjects |
| Pharmacokinetics parameters- Volume of distribution (Vz) | At specified timepoints pre-dose and up to 183 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) | specified timepoints pre-dose and up to 183 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 183 days post first dose administration | Total clearance of the study drug in serum will be analyzed for all subjects |
| Pharmacokinetics parameters- - Elimination Half-life (t1/2). | At specified timepoints pre-dose and up to 183 days post first dose administration | Elimination half-life 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 183 days post first dose administration | Serum Anti-Drug Antibodies will be analyzed for all subjects |
Countries
China
Contacts
CONTACTTracy Ji, Study Director
Outcome results
None listed