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 (2) 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 an independent Phase 1b trial to evaluate the safety and tolerability of BGB-45035 in adults with autoimmune dermatological diseases like atopic dermatitis (AD) and prurigo nodularis (PN). Study details include: * The study duration will be up to 24 months. * The treatment duration will be up to 14 days for Phase 1a and up to 12 weeks for Phase 1b. * 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
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• 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
China
The Affiliated Hospital of Qingdao University Branch West Coast
RECRUITING
Qingdao
Contact Information
Primary
BeiGene
ClinicalTrials@beigene.com
1-877-828-5568
Time Frame
Start Date:2024-06-03
Estimated Completion Date:2026-02-27
Participants
Target number of participants:92
Treatments
Experimental: Phase 1a Part A (Single Ascending Dose)
Phase 1a 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: Phase 1a Part B (Multiple Ascending Dose)
Phase 1a Part B is designed to assess safety, tolerability, PK, and pharmacodynamic profile after repeated dosing of BGB-45035 in healthy participants.
Experimental: Phase 1a Part C (Chinese Substudy)
Phase 1a Part C is designed to assess safety, tolerability, PK, and pharmacodynamic profile after repeated dosing of BGB-45035 in healthy Chinese participants.
Experimental: Phase 1a Part D (Food Effect)
Phase 1a Part D is designed to assess the effect of food on BGB-45035 exposure.
Experimental: Phase 1b Part E (AD Cohort E1)
Phase 1b 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: Phase 1b Part E (PN Cohort E2)
Phase 1b 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.