Actively Recruiting
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
Led by BeiGene · Updated on 2026-04-23
211
Participants Needed
13
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female or male participants aged 18 to 55 years (18 to 45 years for Part C) for Parts A-D and Part F
- Body mass index between 18 and 32 kg/m^2 and weight over 50 kg (110 lbs)
- Signed informed consent provided
- Willing and able to comply with study visits, treatment, tests, and procedures
- Nonsterile males must agree to use effective birth control and avoid sperm donation during the study and for 90 days after last dose
- Females of childbearing potential may join Part F only, must agree to use effective birth control, avoid egg donation during the study and for 90 days after last dose, and have a negative pregnancy test before first dose
- For Part E, males and females aged 18 to 75 years
- Females of childbearing potential in Part E must use effective birth control, avoid egg donation during the study and for 90 days after last dose, and have negative pregnancy test before first dose
- For Atopic Dermatitis Cohort E1: diagnosed chronic AD for at least 1 year, using only nonmedicated topical emollients for 7 days before baseline, with inadequate treatment response, and willing to follow study topical therapy
- For Prurigo Nodularis Cohort E2: diagnosed PN for at least 3 months with at least 20 lesions on specified body parts
- Agree to avoid prolonged sun exposure and tanning devices during the study
You will not qualify if you...
- History or evidence of significant blood, kidney, hormone, lung, digestive, heart, liver, psychiatric, neurological, or allergic diseases (except untreated, asymptomatic seasonal allergies)
- Conditions affecting drug absorption such as gastrectomy or cholecystectomy
- Use of investigational drugs within 30 days or 5 half-lives before first study dose
- ECG with QTcF over 450 milliseconds
- Abnormal chest X-ray within 3 months before screening
- History or active tuberculosis, or positive infection tests
- Use of herbal supplements including St. John's Wort or hormone replacement therapy within 14 days before first dose
- Vaccination with live or attenuated viruses within 6 weeks before first dose, or planned vaccination during treatment or within 8 weeks after treatment completion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 13 locations
1
Innovate Clinical Research
Waitara, New South Wales, Australia, NSW 2077
Actively Recruiting
2
Cmax Clinical Research
Adelaide, South Australia, Australia, SA 5000
Active, Not Recruiting
3
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100000
Completed
4
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 630014
Active, Not Recruiting
5
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, China
Completed
6
Xiangya Hospital of Central South University
Changsha, Hunan, China, 410008
Completed
7
Suzhou Municipal Hospital
Suzhou, Jiangsu, China, 215002
Completed
8
The First Hospital of China Medical University
Shenyang, Liaoning, China, 110001
Completed
9
The Affiliated Hospital of Qingdao University Branch West Coast
Qingdao, Shandong, China, 266555
Active, Not Recruiting
10
Chengdu Second Peoples Hospital
Chengdu, Sichuan, China, 610021
Completed
11
Optimal Clinical Trials Ltd
Auckland, New Zealand, 1010
Actively Recruiting
12
Pacific Clinical Research Network Auckland
Takapuna, New Zealand, 0622
Actively Recruiting
13
Lakeland Clinical Trials Wellington
Upper Hutt, New Zealand, 5018
Actively Recruiting
Research Team
B
BeiGene
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
7
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