Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BBT001 · 3 trials · 2 indications
Incidence, relatedness, and severity of adverse events graded per NCI CTCAE v6.0.
Blood pressure and heart rate will be assessed.
Laboratory assessments include hematology, blood chemistry and coagulation test
Physical examination will be assessed
12-lead ECG will be tested at individual sites using sites' equipment and will be assessed.
Incidence, relatedness, and severity of adverse events graded per NCI CTCAE v5.0.
Physical examination will be assessed.
Laboratory assessments include hematology, blood chemistry and coagulation test
12-lead ECG will be assessed.
| Arm | Type | Description |
|---|---|---|
| Cohort A1:BBT001 (450mg biologic naive) | ACTIVE_COMPARATOR | A multiple ascending dose (MAD) of 450 mg BBT001 will be administered to patients with chronic spontaneous urticaria (CSU) who are naïve to biologic therapy. |
| Cohort A1:Placebo (450mg biologic naive) | PLACEBO_COMPARATOR | A multiple ascending dose (MAD) of 450 mg BBT001 will be administered to patients with chronic spontaneous urticaria (CSU)who are naïve to biologic therapy. |
| Cohort A2:BBT001 (450mg biologic experienced) | ACTIVE_COMPARATOR | A multiple ascending dose (MAD) of 450 mg BBT001 will be administered to patients with chronic spontaneous urticaria (CSU) who are experienced to biologic therapy. |
| Cohort A1:placebo (450mg biologic experienced) | PLACEBO_COMPARATOR | A multiple ascending dose (MAD) of 450 mg BBT001 will be administered to patients with chronic spontaneous urticaria (CSU) who are experienced to biologic therapy |
| Cohort A3:BBT001 (900mg biologic naive) | ACTIVE_COMPARATOR | A multiple ascending dose (MAD) of 900 mg BBT001 will be administered to patients with chronic spontaneous urticaria (CSU) who are naïve to biologic therapy. |
| Cohort A3:Placebo (900mg biologic naive) | PLACEBO_COMPARATOR | A multiple ascending dose (MAD) of 900 mg BBT001 will be administered to patients with chronic spontaneous urticaria (CSU) who are naïve to biologic therapy. |
| Cohort A4:BBT001 (900mg biologic experienced) | ACTIVE_COMPARATOR | A multiple ascending dose (MAD) of 900 mg BBT001 will be administered to patients with chronic spontaneous urticaria (CSU) who are experienced to biologic therapy. |
| Cohort A4:Placobo (900mg biologic experienced) | PLACEBO_COMPARATOR | A multiple ascending dose (MAD) of 900 mg BBT001 will be administered to patients with chronic spontaneous urticaria (CSU) who are experienced to biologic therapy. |
| Part A -BBT001(Single Ascending Dose) | EXPERIMENTAL | A single dose of BBT001 will be administered in healthy volunteers |
| Part A- Placebo(Single Ascending Dose) | EXPERIMENTAL | A single dose of Placebo will be administered in healthy volunteers |
| Part B- BBT001(Multiple Ascending Dose) | EXPERIMENTAL | Seven repeat doses of BBT001 will be administered in patients with moderate to severe atopic dermatitis |
| Part B -Placebo (Multiple Ascending Dose)) | EXPERIMENTAL | Seven repeat doses of Placebo will be administered in patients with moderate to severe atopic dermatitis |
| Part A Single Ascending Dose BBT001 | EXPERIMENTAL | A single dose of BBT001 will be administered in healthy volunteers |
| Part B Multiple Ascending Dose BBT001 | EXPERIMENTAL | Multiple doses of BBT001 will be administered in healthy volunteers. |
| Part C Multiple Ascending Dose BBT001 | EXPERIMENTAL | Multiple doses of BBT001 will be administered in patients with atopic dermatitis. |
| Part A Single Ascending Dose Placebo | PLACEBO_COMPARATOR | A single dose of Placebo will be administered in healthy volunteers |
| Part B Multiple Ascending Dose Placebo | PLACEBO_COMPARATOR | Multiple doses of Placebo will be administered in healthy volunteers. |
| Part C Multiple Ascending Dose Placebo | PLACEBO_COMPARATOR | Multiple doses of Placebo will be administered in patients with atopic dermatitis. |
| Part D Single Ascending Dose BBT001 | ACTIVE_COMPARATOR | A single dose of BBT001 will be administered in healthy volunteers |
| Part D Single Ascending Dose Placebo | PLACEBO_COMPARATOR | A single dose of placebo will be administered in healthy volunteers |
| Part E Multiple Ascending Dose BBT001 - Dose Level 1 | ACTIVE_COMPARATOR | Multiple doses of BBT001 will be administered in patients with atopic dermatitis. |
| Part E Multiple Ascending Dose Placebo | PLACEBO_COMPARATOR | Multiple doses of placebo will be administered in patients with atopic dermatitis. |
| Part E Multiple Ascending Dose BBT001 - Dose Level 2 | ACTIVE_COMPARATOR | Multiple doses of BBT001 will be administered in patients with atopic dermatitis |
| Name | Type | Description |
|---|---|---|
| BBT001 | DRUG | BBT001 will be administered |
| Placebo | DRUG | Placebo will be administered |
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 pr...