Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06342713
PHASE1

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

Sponsor: 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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

211

Start Date

2024-06-20

Completion Date

2026-05-23

Last Updated

2026-03-18

Healthy Volunteers

Yes

Interventions

DRUG

BGB-45035

Administered orally

DRUG

Placebo

Administered orally

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

Optimal Clinical Trials Ltd

Auckland, New Zealand

Pacific Clinical Research Network Auckland

Takapuna, New Zealand

Lakeland Clinical Trials Wellington

Upper Hutt, New Zealand