Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BBT002 · 2 trials · 2 indications
Incidence, relatedness, and severity of adverse events (AEs) graded per CTCAE v5.0.
Laboratory assessments include hematology, coagulation, clinical chemistry and urinalysis
Blood pressure and heart rate will be assessed.
Physical examination will be assessed.
12-lead ECG will be assessed.
| Arm | Type | Description |
|---|---|---|
| Part A Single Ascending Dose BBT002 | EXPERIMENTAL | A single dose of BBT002 will be administered in healthy volunteers |
| Part B Multiple Ascending Dose BBT002 | EXPERIMENTAL | Two doses of BBT002 will be administered in patients with COPD. |
| 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 | Two doses of Placebo will be administered in patients with COPD. |
| Part A: BBT002 | EXPERIMENTAL | A single dose of BBT002 will be administered in healthy volunteers |
| Part B: BBT002 | EXPERIMENTAL | Multiple doses of BBT002 will be administered in healthy volunteers. |
| Part C: BBT002 | EXPERIMENTAL | Multiple doses of BBT002 will be administered in patients with COPD |
| Part A: Placebo | PLACEBO_COMPARATOR | A single dose of Placebo will be administered in healthy volunteers. |
| Part B: Placebo | PLACEBO_COMPARATOR | Multiple doses of Placebo will be administered in healthy volunteers. |
| Part C: Placebo | PLACEBO_COMPARATOR | Multiple doses of Placebo will be administered in patients with COPD. |
| Part D: Placebo | PLACEBO_COMPARATOR | Multiple doses of Placebo will be administered in patients with CRSwNP. |
| Part E: Placebo | PLACEBO_COMPARATOR | Single dose of Placebo will be administered in healthy volunteers. |
| Part F: Placebo | PLACEBO_COMPARATOR | Multiple doses of Placebo will be administered in patients with COPD. |
| Part G: Placebo | PLACEBO_COMPARATOR | Multiple doses of Placebo will be administered in patients with CRSwNP. |
| Part D: BBT002 | EXPERIMENTAL | Multiple doses of BBT002 will be administered in patients with CRSwNP. |
| Part E: BBT002 | EXPERIMENTAL | Single dose of BBT002 will be administered in healthy volunteers. |
| Part F: BBT002 | EXPERIMENTAL | Multiple doses of BBT002 will be administered in patients with COPD. |
| Part G: BBT002 | EXPERIMENTAL | Multiple doses of BBT002 will be administered in patients with CRSwNP. |
| Name | Type | Description |
|---|---|---|
| BBT002 | DRUG | BBT002 will be administered |
| Placebo | DRUG | Placebo will be administered |
Inclusion Criteria:( A\&B) 1. Age of 18-65 years (HVs), 35-75 years (patients) 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-sm...