NCT06342713

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 211 (estimated)
• Sponsor: BeiGene · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	BGB-45035	Administered orally
DRUG	Placebo	Administered orally

Timeline

• Start date: 2024-06-20
• Primary completion: 2026-05-23
• Completion: 2026-05-23
• First posted: 2024-04-02
• Last updated: 2026-04-15

Locations

13 sites across 3 countries: Australia, China, New Zealand