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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
Sponsor: BeiGene
Summary
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.
Official title: Phase 1a/1b Randomized 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 Its Safety and Tolerability in Patients With Autoimmune Dermatological Diseases
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
211
Start Date
2024-06-20
Completion Date
2026-05-23
Last Updated
2026-03-18
Healthy Volunteers
Yes
Conditions
Interventions
BGB-45035
Administered orally
Placebo
Administered orally
Locations (13)
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
Optimal Clinical Trials Ltd
Auckland, New Zealand
Pacific Clinical Research Network Auckland
Takapuna, New Zealand
Lakeland Clinical Trials Wellington
Upper Hutt, New Zealand