A Phase 1, First-time-in-human, Four-part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of GSK4527363 in Healthy Participants (Part A), Participants With Active Systemic Lupus Erythematosus (Part B), Healthy Participants of Chinese and Japanese Descent (Part C) and Participants With Interstitial Lung Disease Associated With Connective Tissue Disease (Part D)
GlaxoSmithKline
Summary
This study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of GSK4527363 in healthy participants (Part A), participants with active SLE (Part B), healthy participants of Chinese and Japanese descent (Part C), and participants with interstitial lung disease associated with connective tissue disease (Part D)
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion criteria: For Part A and Part C (Healthy Participants): * Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent form * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (vital signs and 12-lead ECG) * Part C only: Be of Japanese (Cohort C1) or Chinese (Cohort C2) ancestry i. Born in Japan (Cohort C1) or China mainland, Hong Kong or Taiwan (Cohort C2); and ii. Descendent of 2 ethnic Japanese (Cohort C1) or Chinese (Cohort C2) par…
Interventions
- DrugGSK4527363
GSK4527363 will be administered to participants.
- DrugPlacebo matching GSK4527363
Placebo matching GSK4527363 will be administered to participants.
- DrugBelimumab
Belimumab will be administered to participants.
Locations (27)
- GSK Investigational SiteScottsdale, Arizona
- GSK Investigational SiteAurora, Colorado
- GSK Investigational SiteLas Vegas, Nevada
- GSK Investigational SiteColumbus, Ohio
- GSK Investigational SiteOklahoma City, Oklahoma
- GSK Investigational SiteDallas, Texas