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

NCT ID: NCT06342713

Last Updated: 2026-01-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 211 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-20
• Study Completion Date: 2026-05-23

Brief 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.

Conditions

Healthy Participants; Healthy Subjects; Healthy Volunteers; Autoimmune Diseases; Healthy Adult Participants; Atopic Dermatitis; Prurigo Nodularis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Part A (Single Ascending Dose)

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.

Group Type: EXPERIMENTAL

BGB-45035

Intervention Type: DRUG

Administered orally

Placebo

Intervention Type: DRUG

Administered orally

Part B (Multiple Ascending Dose)

Part B is designed to assess safety, tolerability, PK, and pharmacodynamic profile after repeated dosing of BGB-45035 in healthy participants.

Group Type: EXPERIMENTAL

BGB-45035

Intervention Type: DRUG

Administered orally

Placebo

Intervention Type: DRUG

Administered orally

Part C (Chinese Substudy)

Part C is designed to assess safety, tolerability, PK, and pharmacodynamic profile after repeated dosing of BGB-45035 in healthy Chinese participants.

Group Type: EXPERIMENTAL

BGB-45035

Intervention Type: DRUG

Administered orally

Placebo

Intervention Type: DRUG

Administered orally

Part D (Food Effect)

Part D is designed to assess the effect of food on BGB-45035 exposure.

Group Type: EXPERIMENTAL

BGB-45035

Intervention Type: DRUG

Administered orally

Part E (AD Cohort E1)

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.

Group Type: EXPERIMENTAL

BGB-45035

Intervention Type: DRUG

Administered orally

Part E (PN Cohort E2)

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.

Group Type: EXPERIMENTAL

BGB-45035

Intervention Type: DRUG

Administered orally

Part F (Biomarker Cohort)

Part F is designed to assess the pharmacodynamic activity of BGB-45035 in the skin of healthy volunteers.

Group Type: EXPERIMENTAL

BGB-45035

Intervention Type: DRUG

Administered orally

Interventions

BGB-45035

Administered orally

Intervention Type: DRUG

Placebo

Administered orally

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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 indicating that the participant has been informed of all pertinent aspects of the study.

4. Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

5. Nonsterile male participants must be willing to use a highly effective method of birth control and refrain from sperm donation for the duration of the study and for 90 days after the last dose of study drug.

6. Female participants of childbearing potential can only join Part F and must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for 90 days after the last dose of study drug. They must also have a negative urine pregnancy test at baseline before first dose of study drug.

1. Female or male participants between the ages of 18 to 75 years of age.

2. Female participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for 90 days after the last dose of study drug. They must also have a negative urine pregnancy test at baseline before first dose of study drug.

3. AD Cohort E1:

1. Chronic AD diagnosed by the Eichenfield revised criteria of Hannifin and Rajka that has been present for at least 1 year before the Screening Visit.

2. Prior to baseline assessment, participants with AD must have used only nonmedicated topical emollients twice daily for at least 7 days, without any active ingredients or additives that could impact AD treatment (such as hyaluronic acid, urea, ceramide, or filaggrin degradation products). Participant's response to treatment must have remained inadequate at baseline. Additionally, the participant must be willing and able to adhere to standardized background topical therapy as outlined in the protocol throughout the remainder of the study.

4. PN Cohort E2:

1. Diagnosed as PN by a dermatologist for at least 3 months before the Screening Visit with prurigo lesions on upper limbs with or without lesions on the trunk or lower limbs.

2. Minimum of 20 PN lesions in total on either of the following: both legs, both arms, and/or the trunk at the Screening Visit and on Day 1.

1. Must agree to avoid prolonged exposure to the sun and not to use tanning booths, sun lamps, or other ultraviolet light sources during the study.

Exclusion Criteria

1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

2. Any condition possibly affecting drug absorption (eg, gastrectomy or cholecystectomy).

3. Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of investigational product, whichever is longer.

4. 12-lead ECG demonstrating QTcF > 450 milliseconds.

5. Clinically significant abnormality on chest radiograph performed at screening or within 3 months of screening date.

6. History of tuberculosis or active or latent or inadequately treated infection, positive IGRA tests

7. Herbal supplements (including St. John's Wort) and hormone replacement therapy must be discontinued 14 days prior to the first dose of study medication.

8. Vaccination with live virus, attenuated live virus, or any live viral components within the 6 weeks prior to the first dose of study drug or is to receive these vaccines at any time during treatment or within 8 weeks following completion of study treatment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

BeiGene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

BeiGene

Locations

Innovate Clinical Research

Waitara, New South Wales, Australia

Site Status: RECRUITING

Cmax Clinical Research

Adelaide, South Australia, Australia

Site Status: RECRUITING

Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status: RECRUITING

Suzhou Municipal Hospital

Suzhou, Jiangsu, China

Site Status: RECRUITING

The First Hospital of China Medical University

Shenyang, Liaoning, China

Site Status: RECRUITING

The Affiliated Hospital of Qingdao University Branch West Coast

Qingdao, Shandong, China

Site Status: RECRUITING

Chengdu Second Peoples Hospital

Chengdu, Sichuan, China

Site Status: RECRUITING

Optimal Clinical Trials Ltd

Auckland, , New Zealand

Site Status: RECRUITING

Pacific Clinical Research Network Auckland

Takapuna, , New Zealand

Site Status: RECRUITING

Lakeland Clinical Trials Wellington

Upper Hutt, , New Zealand

Site Status: RECRUITING

Countries

Australia; China; New Zealand

Central Contacts

BeiGene

Role: CONTACT

ClinicalTrials@beigene.com

1-877-828-5568

Other Identifiers

CTR20243170

Identifier Type: REGISTRY

Identifier Source: secondary_id

BGB-45035-101

Identifier Type: -

Identifier Source: org_study_id