Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06342713 | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases | PHASE1 | RECRUITING | 211 | — | — | Jun 20, 2024 | May 23, 2026 | Apr 23, 2026 | 13 | Australia, China +1 |
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...