This study is the first-in-human (FIH) study of BGB-45035. The study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BGB-45035 with both a single dose and multiple doses administered at different dose levels in healthy participants, followed by a Part E to evaluate the safety and tolerability of BGB-45035 in adults with autoimmune dermatological diseases like atopic dermatitis (AD) and prurigo nodularis (PN). An additional biomarker cohort will be evaluated in Part F. Study details include: * The study duration will be up to 24 months. * The treatment duration will be up to 14 days for Parts A-D, up to 12 weeks for Part E, and up to 3 weeks for Part F. * Safety follow-up 30 days after last dose of study drug.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
203
Innovate Clinical Research
Waitara, New South Wales, Australia
Cmax Clinical Research
Adelaide, South Australia, Australia
Peking University Third Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
Suzhou Municipal Hospital
Suzhou, Jiangsu, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
The Affiliated Hospital of Qingdao University Branch West Coast
Qingdao, Shandong, China
Chengdu Second Peoples Hospital
Chengdu, Sichuan, China
...and 3 more locations
Number of Participants Experiencing Adverse Events (AEs) in Parts A-E
Time frame: From the first dose of study drug to 30 days after the last dose; up to approximately 44 days for Parts A-D and up to 16 weeks for Part E
Parts A-D: Number of participants with clinically significant changes from baseline in clinical laboratory values
Laboratory values include hematology, clinical chemistry, coagulation, and urinalysis
Time frame: Baseline and up to approximately 1 month
Parts A-D: Number of participants with clinically significant changes from baseline in vital signs
Vital signs include blood pressure and pulse rate
Time frame: Baseline and up to approximately 1 month
Parts A-D: Number of participants with clinically significant changes from baseline in cardiac conduction intervals
As assessed via 12-lead electrocardiogram (ECG)
Time frame: Baseline and up to approximately 1 month
Parts A & D: Area under the plasma concentration time curve from time zero to last quantifiable time (AUClast) of BGB-45035
Time frame: Up to approximately 14 days
Parts A & D: Area under the plasma concentration time curve from time zero to infinite time (AUCinf) of BGB-45035
Time frame: Up to approximately 14 days
Parts B & C: Area under the plasma concentration time curve from time zero to end of dosing interval (AUCtau) of BGB-45035
Time frame: Up to approximately 14 days
Parts A, B, C & D: Maximum observed plasma concentration (Cmax) of BGB-45035
Time frame: Up to approximately 14 days
Parts A, B, C & D: Time to maximum plasma concentration (Tmax) of BGB-45035
Time frame: Up to approximately 14 days
Parts B & C: Trough plasma concentration (Ctrough) of BGB-45035
Time frame: Up to approximately 14 days
Parts A, B, C & D: Half life (t½) of BGB-45035
Time frame: Up to approximately 14 days
Parts A, B, & C: Apparent systemic clearance (CL/F) of BGB-45035
Time frame: Up to approximately 14 days
Parts A, B, & C: Apparent volume of distribution (Vz/F) of BGB-45035
Time frame: Up to approximately 14 days
Parts B & C: Accumulation Ratios of BGB-45035
Time frame: Up to approximately 14 days
Part E (AD Cohort E1): Change from baseline in Eczema Area and Severity Index (EASI) score at all scheduled visits
Time frame: Baseline and up to 16 weeks
Part E (AD Cohort E1): Change from baseline in Investigator Global Assessment (IGA) scale for Atopic Dermatitis (IGA-AD) score at all scheduled visits
Time frame: Baseline and up to 16 weeks
Part E (PN Cohort E2): Change from baseline in Investigator Global Assessment (IGA) Stage score at all scheduled visits
Time frame: Baseline and up to 16 weeks
Part E (PN Cohort E2): Change from baseline in Investigator Global Assessment (IGA) Activity score at all scheduled visits
Time frame: Baseline and up to 16 weeks
Part E: Change from baseline of Peak Pruritus Numerical Rating Scale (PP-NRS) at all scheduled visits
Time frame: Baseline and up to 16 weeks
Part E: Change from baseline in Average of Pruritus Numerical Rating Scale (AP-NRS) at all scheduled visits
Time frame: Baseline and up to 16 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.