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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 | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

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

NCT06342713•BeiGene

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

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.
+5 more criteria

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.

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

Key Dates

Start Date

June 20, 2024

Primary Completion Date

May 23, 2026

Completion Date

May 23, 2026

Last Updated

March 18, 2026

Enrollment

211

ESTIMATED participants

Conditions

Healthy ParticipantsHealthy SubjectsHealthy VolunteersAutoimmune DiseasesHealthy Adult ParticipantsAtopic DermatitisPrurigo Nodularis

Interventions

BGB-45035

DRUG

Placebo

DRUG

Contacts

BeiGene

CONTACT

1-877-828-5568 ClinicalTrials@beigene.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 18, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

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