Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 drug being developed by BeOne Medicines Ltd. for autoimmune diseases. It is in Phase 1 clinical development and is designed to be taken as an oral therapy. The program includes a study in healthy participants and adults with autoimmune dermatological diseases.
BGB-45035 is being studied for autoimmune diseases, with the Phase 1 trial enrolling healthy participants and adults with autoimmune dermatological conditions including atopic dermatitis and prurigo nodularis. It has not been approved for any indication and remains investigational.
BGB-45035 targets IRAK4, a kinase enzyme involved in inflammatory signaling pathways. By inhibiting IRAK4, the drug is intended to modulate immune responses relevant to autoimmune diseases. IRAK4 inhibition is being explored as an approach for conditions driven by innate immune activation.
BGB-45035 is being developed by BeOne Medicines Ltd., which trades under the ticker ONC. BeOne Medicines is the sponsor of the Phase 1 clinical program evaluating the drug in healthy participants and adults with autoimmune dermatological diseases.
BGB-45035 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA or any other regulatory agency. The ongoing Phase 1 study is evaluating safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy participants and adults with autoimmune dermatological diseases.
BGB-45035 is being evaluated in one active clinical trial, NCT06342713, titled a study of safety, tolerability, pharmacokinetics, and pharmacodynamics of single- and multiple-ascending doses and food effect in healthy participants and adults with autoimmune dermatological diseases. The trial is recruiting, randomized, double-blind, and controlled, with planned enrollment of 211 participants across Australia, China, and New Zealand.