Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BBT002 · 1 trial · 1 indication
Incidence, relatedness, and severity of AEs graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v6.0.
Changes in vital sign measurements, physical examination, clinical laboratory test findings, and 12-lead results.
Physical examination will be assessed.
Laboratory assessments include hematology, coagulation, clinical chemistry and urinalysis
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 | Five doses of BBT002 will be administered in patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) with or without Asthma |
| 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 | Five doses of BBT002 will be administered in patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) with or without Asthma |
| Name | Type | Description |
|---|---|---|
| BBT002 | DRUG | BBT002 will be administered. |
| Placebo | DRUG | Placebo will be administered |
Inclusion Criteria: Part (A\&B): 1. Age of 18-55 years (HVs), 18-75 years (patients) 2. Body mass index between 18-30 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. ...
BBT002 is an investigational small molecule being developed for Chronic Rhinosinusitis With Nasal Polyps (CRSwNP), a condition in the ear, nose, and throat (ENT) therapeutic area. It is currently in Phase 1 clinical development and has not been approved by any regulatory authority.
BBT002 is being developed by cbdMD, Inc., a company traded on the stock exchange under the ticker YCBD. The drug is in Phase 1 clinical development for Chronic Rhinosinusitis With Nasal Polyps (CRSwNP).
BBT002 is in Phase 1 clinical development. It is an investigational drug and has not been approved for any use. The ongoing Phase 1 trial is recruiting participants and is designed to evaluate the drug in healthy volunteers and in patients with Chronic Rhinosinusitis With Nasal Polyps (CRSwNP).
BBT002 is being studied in one active clinical trial, identified as NCT07436949. This Phase 1 study is recruiting 64 participants in China and includes healthy volunteers as well as patients with Chronic Rhinosinusitis With Nasal Polyps (CRSwNP), with or without comorbid asthma. The trial is double-blind and placebo-controlled.
BBT002 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Chronic Rhinosinusitis With Nasal Polyps (CRSwNP). The drug is being studied in a clinical trial that is still recruiting participants, and its safety and efficacy have not been established.