ClinicaliQ Trial Snapshot
- A Study of GSK4527363 in Healthy Participants, Systemic Lupus Erythematosus (SLE) Participants, Healthy Chinese, and Japanese Participants and CTD-ILD Participants — Recruiting • Phase I • Respiratory / COPD / Asthma • NCT06576271.
- GSK4527363 is a novel investigational agent being evaluated for safety, tolerability, and pharmacokinetic/pharmacodynamic properties across healthy volunteers and patients with SLE and connective tissue disease-associated interstitial lung disease (CTD-ILD).
- Patient eligibility spans four cohorts: healthy participants (UK/other populations), adults with active SLE meeting standard diagnostic criteria, healthy volunteers of Chinese and Japanese descent, and patients with CTD-ILD—allowing assessment of drug performance across diverse populations and disease states.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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 Snapshot
- : 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…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.