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
Latest Information Update: 07 Jun 2025
At a glance
- Drugs BGB 45035 (Primary)
- Indications Autoimmune disorders
- Focus Adverse reactions; First in man
- Sponsors BeiGene
Most Recent Events
- 04 Apr 2025 No of arms has been changed from 6 to 7,addition of Biomarker Cohort part F in open label
- 21 Feb 2025 Planned number of patients changed from 92 to 195.
- 15 Jan 2025 Protocol amended to include changes in study design, endpoints, inclusion criteria.