Actively Recruiting
Phase 1a/1b Study Evaluating Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BGB-45035 in Healthy Adults and Adults With Autoimmune Dermatological Diseases
Led by BeiGene · Updated on 2026-04-23
211
Participants Needed
13
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying BGB-45035, a drug being evaluated for safety, tolerability, and how it behaves in the body when given in single and multiple doses. This first-in-human study includes healthy adults and later adults with autoimmune skin diseases like atopic dermatitis (AD) and prurigo nodularis (PN). The study aims to understand how the drug works and its effects over a treatment period lasting up to 24 months. The study is divided into several parts: Parts A through D involve healthy participants receiving single or multiple doses of BGB-45035 or placebo to assess safety and drug behavior, including a food effect study. Part E focuses on adults with moderate to severe AD or PN receiving BGB-45035 for up to 12 weeks to evaluate safety and tolerability. Part F examines the drug’s effects on skin biomarkers in healthy volunteers over about 3 weeks. Treatment is given orally, and dosing varies by study part. Participants will attend scheduled visits for treatment, safety monitoring, laboratory tests, and questionnaires. Researchers will monitor adverse events, vital signs, heart function, and lab values up to 30 days after the last dose. For those with AD or PN, changes in disease severity and itch intensity will be assessed through specific scales over 16 weeks. The total study duration varies by part but can last up to two years including follow-up.
CONDITIONS
Brief 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 for Parts A-D and Part F; 18 to 45 years for Part C; 18 to 75 years for Part E
- Body mass index (BMI) between 18 and 32 kg/m² and body weight over 50 kg (110 lbs)
- Signed informed consent indicating understanding of the study
- Willing and able to follow study visits, treatment, lab tests, and procedures
- Nonsterile males must agree to use effective birth control and avoid sperm donation during and 90 days after the study
- Females of childbearing potential can join Part F only and must use effective birth control, avoid egg donation during and 90 days after the study, and have a negative pregnancy test before dosing
- For Part E: diagnosis of moderate to severe atopic dermatitis or prurigo nodularis with specific criteria
- Agreement to avoid prolonged sun exposure and tanning devices during the study
You will not qualify if you...
- History or presence of significant blood, kidney, hormone, lung, digestive, heart, liver, mental, nervous system, or allergic diseases (except untreated, mild seasonal allergies)
- Conditions that may affect drug absorption like gastrectomy or gallbladder removal
- Use of investigational drugs within 30 days or five half-lives before the first dose
- Electrocardiogram showing QTcF longer than 450 milliseconds
- Abnormal chest X-ray within 3 months before screening
- History of or active tuberculosis or positive tuberculosis test
- Use of herbal supplements or hormone therapy within 14 days before dosing
- Vaccination with live or attenuated viruses within 6 weeks before dosing or planned during treatment and 8 weeks after
- Other protocol-defined criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 16 weeks depending on cohort
Participants receive oral doses of BGB-45035 or placebo in various dosing schedules to assess safety, tolerability, pharmacokinetics, and pharmacodynamics.
Multiple visits depending on the part: single ascending dose, multiple ascending doses, food effect assessments, or treatment in participants with autoimmune dermatological diseases
Duration - Up to 30 days after last dose
Participants are monitored for safety and adverse events up to 30 days after the last dose of study drug.
1 to 2 visits depending on cohort
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
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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