A Phase 1, First-time-in-human, Three-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), and Healthy Participants of Chinese and Japanese Descent (Part C)

Status: Recruiting
Location: See all (21) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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), and healthy participants of Chinese and Japanese descent (Part C)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

⁃ 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) parents and 4 ethnic grandparents; and iii. Have lived outside Japan (Cohort C1) or China mainland, Hong Kong or Taiwan (Cohort C2) for less than 10 years at the time of screening.

• Body weight greater than or equals to (\>=) 45 kilograms (kg).

• Body mass index (BMI) within the range 18-32 kilograms per square meter (kg/m\^2) (inclusive).

• Male or female of non-childbearing potential

⁃ For Part B (SLE participants):

• 18 to 65 years of age inclusive, at the time of signing the informed consent form

• Documented clinical diagnosis of SLE according to the (European alliance of associations of rheumatology \[EULAR\]/ American College of Rheumatology \[ACR\] SLE classification criteria)

• Body weight \>= 45 kg.

• BMI within the range 18-32 kg/m\^2 (inclusive).

• Male or female

Locations
United States
Arizona
GSK Investigational Site
WITHDRAWN
Scottsdale
Nevada
GSK Investigational Site
RECRUITING
Las Vegas
Ohio
GSK Investigational Site
RECRUITING
Columbus
Other Locations
Argentina
GSK Investigational Site
RECRUITING
Buenos Aires
GSK Investigational Site
RECRUITING
Rosario
GSK Investigational Site
RECRUITING
San Miguel De Tucumán
Brazil
GSK Investigational Site
RECRUITING
Juiz De Fora
GSK Investigational Site
RECRUITING
Porto Alegre
GSK Investigational Site
RECRUITING
Salvador
Poland
GSK Investigational Site
RECRUITING
Bydgoszcz
GSK Investigational Site
RECRUITING
Poznan
GSK Investigational Site
RECRUITING
Warsaw
GSK Investigational Site
RECRUITING
Wroclaw
Spain
GSK Investigational Site
RECRUITING
Barcelona
GSK Investigational Site
RECRUITING
Bilbao
GSK Investigational Site
RECRUITING
Pamplona
GSK Investigational Site
RECRUITING
Sabadell Barcelona
GSK Investigational Site
RECRUITING
Valladolid
United Kingdom
GSK Investigational Site
RECRUITING
Cambridge
GSK Investigational Site
RECRUITING
Liverpool
GSK Investigational Site
RECRUITING
Middlesex
Contact Information
Primary
US GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
877-379-3718
Backup
EU GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
+44 (0) 20 89904466
Time Frame
Start Date: 2024-09-02
Estimated Completion Date: 2028-01-11
Participants
Target number of participants: 142
Treatments
Experimental: Part A: Healthy participants receiving GSK4527363
Placebo_comparator: Part A: Healthy participants receiving placebo matching GSK4527363
Experimental: Part A: Healthy participants receiving belimumab
Experimental: Part B: Participants with SLE receiving GSK4527363
Experimental: Part B: Participants with SLE receiving belimumab
Experimental: Part C: Healthy Japanese participants receiving GSK4527363
Placebo_comparator: Part C: Healthy Japanese participants receiving placebo matching GSK4527363
Experimental: Part C: Healthy Chinese participants receiving GSK4527363
Placebo_comparator: Part C: Healthy Chinese participants receiving placebo matching GSK4527363
Related Therapeutic Areas
Sponsors
Leads: GlaxoSmithKline

This content was sourced from clinicaltrials.gov

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