GSK Investigational Site
Anaheim, California, 92801, United States
NCT Number: NCT04366349
GSK3772847, an anti-interleukin (IL) 33-receptor monoclonal antibody, is a novel treatment for asthma. The purpose of this study to evaluate the safety and tolerability, PK and PD of single ascending doses of GSK3772847 administered subcutaneously (SC) to healthy participants. This study will also establish the bioavailability of SC formulation and evaluate the safety in particular injection site tolerability of route. Participants will either receive a single dose of 70 milligram (mg) GSK3772847 or placebo in (Cohort 1) and 140 mg GSK3772847 or placebo in Cohorts 2, 3 (Japanese participants) and 4 (Chinese participants). The site of injection will be upper arm; abdomen or thigh for cohorts 1 and 2 with cohorts 3 and 4 will receive injections in the upper arm only. Approximately, the total duration of study will be up to 89 days.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 1
Anaheim, California, 92801, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
melrilimab (GSK3772837) will be available at a dose strength of 70 milligram per milliliter (mg/mL) in a 3 milliliter (mL) glass vial.
Two doses of melrilimab (GSK3772837) 70 milligram per milliliter (mg/mL) will be administered to achieve a dose strength of 140 milligram per milliliter (mg/mL)
Placebo to match melrilimab (GSK3772847) will be available in the form of solution for injection in a 3 milliliter (mL) glass vial.
Time frame: Up to Day 85
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, and other situations which involve medical or scientific judgment.
Time frame: Day 1: Pre-dose, 2, 4, 8 hours post-dose; Days 2, 3, 4, 5, 6, 9, 15, 29, 43, 57, 71 and 85
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3772847. Pharmacokinetic Population consisted of all randomized participants who received at least one dose of study treatment, and for whom at least one pharmacokinetic sample was obtained, analyzed and measurable.
Time frame: Day 1: Pre-dose, 2, 4, 8 hours post-dose; Days 2, 3, 4, 5, 6, 9, 15, 29, 43, 57, 71 and 85
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3772847.
Time frame: Day 1: Pre-dose, 2, 4, 8 hours post-dose; Days 2, 3, 4, 5, 6, 9, 15, 29, 43, 57, 71 and 85
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3772847.
Time frame: Day 1: Pre-dose, 2, 4, 8 hours post-dose; Days 2, 3, 4, 5, 6, 9, 15, 29, 43, 57, 71 and 85
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3772847.
Time frame: Day 1: Pre-dose, 2, 4, 8 hours post-dose; Days 2, 3, 4, 5, 6, 9, 15, 29, 43, 57, 71 and 85
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3772847.
Time frame: Baseline and up to Day 85/early withdrawal
Blood samples were collected to measure free soluble ST2 concentration. Maximal decrease from Baseline was the largest decrease calculated across all time points post dose. Ratio to Baseline is defined as post-dose visit value divided by Baseline value. Baseline was the most recent recorded value before dosing on Day 1 (Pre-dose). Pharmacodynamic Population consisted of all randomized participants who received at least one dose of study treatment, and for whom at least one pharmacokinetic sample was obtained, analyzed and measurable.
Time frame: Baseline and up to Day 85/early withdrawal
Blood samples were collected to measure total soluble ST2 concentration. Maximal increase from Baseline was the largest increase calculated across all timepoints post dose. Ratio to Baseline is defined as post-dose visit value divided by Baseline value. Baseline was the most recent recorded value before dosing on Day 1 (Pre-dose).
Time frame: Days 1, 15, 29, 57 and 85/early withdrawal
Serum samples were collected at indicated time points and analyzed for the presence of anti-GSK3772847 antibodies using a tiered approach including a screening assay, a confirmation assay and calculation of titer.
Time frame: Baseline, Days 5, 15, 29 and 85/early withdrawal
Blood samples were collected at indicated time points to measure 4BetaOH cholesterol/cholesterol. Ratio to Baseline is defined as post-dose visit value divided by Baseline value. Baseline value was the latest pre-dose assessment (Day 1 Pre-dose).
GlaxoSmithKline
Industry
A Randomized, Double-blind, Single Ascending Dose Study to Determine the Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of GSK3772847 Administered Subcutaneously in Healthy Participants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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