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

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: t
View:

• 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.

• 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.

∙ 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.

Locations
Other Locations
Australia
Cmax Clinical Research
RECRUITING
Adelaide
Innovate Clinical Research
RECRUITING
Waitara
China
Peking University Third Hospital
RECRUITING
Beijing
Xiangya Hospital of Central South University
RECRUITING
Changsha
Chengdu Second Peoples Hospital
RECRUITING
Chengdu
The First Affiliated Hospital of Chongqing Medical University
RECRUITING
Chongqing
Dermatology Hospital of Southern Medical University
RECRUITING
Guangzhou
The Affiliated Hospital of Qingdao University Branch West Coast
RECRUITING
Qingdao
The First Hospital of China Medical University
RECRUITING
Shenyang
Suzhou Municipal Hospital
RECRUITING
Suzhou
New Zealand
Optimal Clinical Trials Ltd
RECRUITING
Auckland
Pacific Clinical Research Network Auckland
RECRUITING
Takapuna
Lakeland Clinical Trials Wellington
RECRUITING
Upper Hutt
Contact Information
Primary
BeiGene
ClinicalTrials@beigene.com
1-877-828-5568
Time Frame
Start Date: 2024-06-03
Estimated Completion Date: 2026-05-23
Participants
Target number of participants: 211
Treatments
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: Part D (Food Effect)
Part D is designed to assess the effect of food on BGB-45035 exposure.
Experimental: 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.
Experimental: 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.
Experimental: Part F (Biomarker Cohort)
Part F is designed to assess the pharmacodynamic activity of BGB-45035 in the skin of healthy volunteers.
Related Therapeutic Areas
Sponsors
Leads: BeiGene

This content was sourced from clinicaltrials.gov

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