Approval Probability
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BGB-45035 · 1 trial · 7 indications
Laboratory values include hematology, clinical chemistry, coagulation, and urinalysis
Vital signs include blood pressure and pulse rate
As assessed via 12-lead electrocardiogram (ECG)
| Arm | Type | Description |
|---|---|---|
| Part A (Single Ascending Dose) | EXPERIMENTAL | Part A is designed to assess the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic profile of BGB-45035 following single-ascending doses (SAD) in healthy participants. |
| Part B (Multiple Ascending Dose) | EXPERIMENTAL | Part B is designed to assess safety, tolerability, PK, and pharmacodynamic profile after repeated dosing of BGB-45035 in healthy participants. |
| Part C (Chinese Substudy) | EXPERIMENTAL | Part C is designed to assess safety, tolerability, PK, and pharmacodynamic profile after repeated dosing of BGB-45035 in healthy Chinese participants. |
| Part D (Food Effect) | EXPERIMENTAL | Part D is designed to assess the effect of food on BGB-45035 exposure. |
| Part E (AD Cohort E1) | EXPERIMENTAL | AD Cohort E1 is designed to assess the safety, tolerability, and efficacy of a selected dose of BGB-45035 in participants with moderate to severe AD. |
| Part E (PN Cohort E2) | EXPERIMENTAL | PN Cohort E2 is designed to assess the safety, tolerability, and efficacy of a targeted dose of BGB-45035 in participants with moderate to severe PN. |
| Part F (Biomarker Cohort) | EXPERIMENTAL | Part F is designed to assess the pharmacodynamic activity of BGB-45035 in the skin of healthy volunteers. |
| Name | Type | Description |
|---|---|---|
| BGB-45035 | DRUG | Administered orally |
| Placebo | DRUG | Administered orally |
Inclusion Criteria for Parts A-D and Part F: 1. Female or male participants between the ages of 18 and 55 years inclusive (ages 18 and 45 years for Part C). 2. BMI of 18 to 32 kg/m\^2; and a total body weight \> 50 kg (110 lbs). 3. Evidence of a personally signed and dated informed consent document...
BGB-45035 is an investigational small molecule being studied in healthy participants and in adults with autoimmune dermatological diseases, including atopic dermatitis and prurigo nodularis. It is currently in Phase 1 clinical development for these conditions.
BGB-45035 targets IRAK4, a kinase involved in immune signaling. By inhibiting IRAK4, the drug is being studied for its potential effects in autoimmune dermatological diseases such as atopic dermatitis and prurigo nodularis.
BGB-45035 is being developed by BeOne Medicines Ltd., a biopharmaceutical company listed on the stock exchange under the ticker ONC.
BGB-45035 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics.
BGB-45035 is being studied in a single Phase 1 clinical trial, NCT06342713. This randomized, double-blind, controlled study evaluates single- and multiple-ascending doses and food effects in healthy participants and adults with autoimmune dermatological diseases. The trial is recruiting 211 participants in Australia, China, and New Zealand.