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Healthy ParticipantsPhase 1NCT06342713

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

A Phase 1 study testing BGB-45035 in people with Healthy Participants and Healthy Subjects, run by BeiGene at 13 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
What is being tested?
BGB-45035
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
203 participants
Where
13 sitesin 3 countries
Study dates
20 Jun 2024to 2 Jun 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Female or male participants between the ages of 18 and 55 years inclusive (ages 18 and 45 years for Part C).
  • BMI of 18 to 32 kg/m^2; and a total body weight > 50 kg (110 lbs).
  • Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study.
  • Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
  • 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.
  • 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.
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  • Female or male participants between the ages of 18 to 75 years of age.
  • 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.
  • AD Cohort E1:
  • 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.
  • 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.
  • PN Cohort E2:
  • 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.
  • 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.
  • General Inclusion Criteria:
  • 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.

Who cannot join

  • 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).
  • Any condition possibly affecting drug absorption (eg, gastrectomy or cholecystectomy).
  • 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.
  • 12-lead ECG demonstrating QTcF > 450 milliseconds.
  • Clinically significant abnormality on chest radiograph performed at screening or within 3 months of screening date.
  • History of tuberculosis or active or latent or inadequately treated infection, positive IGRA tests
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  • Herbal supplements (including St. John's Wort) and hormone replacement therapy must be discontinued 14 days prior to the first dose of study medication.
  • 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.
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

13 sites in 3 countries.

13 sites in 3 countries

China8 sites

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100000

  • Xiangya Hospital of Central South University

    Changsha, Hunan, 410008

  • Chengdu Second Peoples Hospital

    Chengdu, Sichuan, 610021

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 630014

  • Dermatology Hospital of Southern Medical University

    Guangzhou, Guangdong

  • The Affiliated Hospital of Qingdao University Branch West Coast

    Qingdao, Shandong, 266555

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110001

  • Suzhou Municipal Hospital

    Suzhou, Jiangsu, 215002

Other trials in China

New Zealand3 sites

  • Optimal Clinical Trials Ltd

    Auckland, 1010

  • Pacific Clinical Research Network Auckland

    Takapuna, 0622

  • Lakeland Clinical Trials Wellington

    Upper Hutt, 5018

Other trials in New Zealand

Australia2 sites

  • Cmax Clinical Research

    Adelaide, South Australia, SA 5000

  • Innovate Clinical Research

    Waitara, New South Wales, NSW 2077

Other trials in Australia

About this study

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

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.
Being tested
BGB-45035, Placebo
Keywords
Healthy Volunteers, Healthy Subjects, Healthy Participants, BGB-45035, Healthy Adult Participants, IL-33-induced skin inflammation, atopic dermatitis, prurigo nodularis, IRAK4, CDAC
Medical subject headings
Autoimmune Diseases, Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BGB-45035Drug

    Administered orally

  • PlaceboDrug

    Administered orally

Study groups in NCT06342713
Study groupRoleWhat they receive
Part A (Single Ascending Dose)ExperimentalPart A is designed to assess the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic profile of BGB-45035 following single-ascending doses (SAD) in healthy participants.
Receives: Drug: BGB-45035; Drug: Placebo
Part B (Multiple Ascending Dose)ExperimentalPart B is designed to assess safety, tolerability, PK, and pharmacodynamic profile after repeated dosing of BGB-45035 in healthy participants.
Receives: Drug: BGB-45035; Drug: Placebo
Part C (Chinese Substudy)ExperimentalPart C is designed to assess safety, tolerability, PK, and pharmacodynamic profile after repeated dosing of BGB-45035 in healthy Chinese participants.
Receives: Drug: BGB-45035; Drug: Placebo
Part D (Food Effect)ExperimentalPart D is designed to assess the effect of food on BGB-45035 exposure.
Receives: Drug: BGB-45035
Part E (AD Cohort E1)ExperimentalAD 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.
Receives: Drug: BGB-45035
Part E (PN Cohort E2)ExperimentalPN 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.
Receives: Drug: BGB-45035
Part F (Biomarker Cohort)ExperimentalPart F is designed to assess the pharmacodynamic activity of BGB-45035 in the skin of healthy volunteers.
Receives: Drug: BGB-45035

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Experiencing Adverse Events (AEs) in Parts A-E

    Measured: From the first dose of study drug to 30 days after the last dose; up to approximately 44 days for Parts A-D and up to 16 weeks for Part E

  2. Parts A-D: Number of participants with clinically significant changes from baseline in clinical laboratory values

    Laboratory values include hematology, clinical chemistry, coagulation, and urinalysis

    Measured: Baseline and up to approximately 1 month

  3. Parts A-D: Number of participants with clinically significant changes from baseline in vital signs

    Vital signs include blood pressure and pulse rate

    Measured: Baseline and up to approximately 1 month

  4. Parts A-D: Number of participants with clinically significant changes from baseline in cardiac conduction intervals

    As assessed via 12-lead electrocardiogram (ECG)

    Measured: Baseline and up to approximately 1 month

Secondary outcomes (16)

  1. Parts A & D: Area under the plasma concentration time curve from time zero to last quantifiable time (AUClast) of BGB-45035

    Measured: Up to approximately 14 days

  2. Parts A & D: Area under the plasma concentration time curve from time zero to infinite time (AUCinf) of BGB-45035

    Measured: Up to approximately 14 days

  3. Parts B & C: Area under the plasma concentration time curve from time zero to end of dosing interval (AUCtau) of BGB-45035

    Measured: Up to approximately 14 days

  4. Parts A, B, C & D: Maximum observed plasma concentration (Cmax) of BGB-45035

    Measured: Up to approximately 14 days

  5. Parts A, B, C & D: Time to maximum plasma concentration (Tmax) of BGB-45035

    Measured: Up to approximately 14 days

  6. Parts B & C: Trough plasma concentration (Ctrough) of BGB-45035

    Measured: Up to approximately 14 days

  7. Parts A, B, C & D: Half life (t½) of BGB-45035

    Measured: Up to approximately 14 days

  8. Parts A, B, & C: Apparent systemic clearance (CL/F) of BGB-45035

    Measured: Up to approximately 14 days

  9. Parts A, B, & C: Apparent volume of distribution (Vz/F) of BGB-45035

    Measured: Up to approximately 14 days

  10. Parts B & C: Accumulation Ratios of BGB-45035

    Measured: Up to approximately 14 days

  11. Part E (AD Cohort E1): Change from baseline in Eczema Area and Severity Index (EASI) score at all scheduled visits

    Measured: Baseline and up to 16 weeks

  12. Part E (AD Cohort E1): Change from baseline in Investigator Global Assessment (IGA) scale for Atopic Dermatitis (IGA-AD) score at all scheduled visits

    Measured: Baseline and up to 16 weeks

  13. Part E (PN Cohort E2): Change from baseline in Investigator Global Assessment (IGA) Stage score at all scheduled visits

    Measured: Baseline and up to 16 weeks

  14. Part E (PN Cohort E2): Change from baseline in Investigator Global Assessment (IGA) Activity score at all scheduled visits

    Measured: Baseline and up to 16 weeks

  15. Part E: Change from baseline of Peak Pruritus Numerical Rating Scale (PP-NRS) at all scheduled visits

    Measured: Baseline and up to 16 weeks

  16. Part E: Change from baseline in Average of Pruritus Numerical Rating Scale (AP-NRS) at all scheduled visits

    Measured: Baseline and up to 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2024
  2. Study start20 Jun 2024
  3. Primary completion2 Jun 2026
  4. Study completion2 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
203 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06342713
Sponsor's protocol ID
BGB-45035-101
Other IDs
CTR20243170
Status last verified
Jun 2026
First submitted
26 Mar 2024
Last updated
22 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BGB-45035 in people with Healthy Participants and Healthy Subjects, run by BeiGene at 13 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in China, New Zealand, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Experiencing Adverse Events (AEs) in Parts A-E (time frame: From the first dose of study drug to 30 days after the last dose; up to approximately 44 days for Parts A-D and up to 16 weeks for Part E). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06342713.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.

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