NCT04366349

A Study to Evaluate the Safety and Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Melrilimab (GSK3772847) in Healthy Participants

A Randomized, Double-blind, Single Ascending Dose Study to Determine the Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of GSK3772847 Administered Subcutaneously in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy Volunteers
• Asthma

Interventions

Type	Name	Description
BIOLOGICAL	melrilimab (GSK3772847) 70 milligram (mg)	melrilimab (GSK3772837) will be available at a dose strength of 70 milligram per milliliter (mg/mL) in a 3 milliliter (mL) glass vial.
BIOLOGICAL	melrilimab (GSK3772847) 140 milligram (mg)	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)
OTHER	Placebo	Placebo to match melrilimab (GSK3772847) will be available in the form of solution for injection in a 3 milliliter (mL) glass vial.

Timeline

• Start date: 2020-07-21
• Primary completion: 2020-12-21
• Completion: 2020-12-21
• First posted: 2020-04-28
• Last updated: 2021-11-05
• Results posted: 2021-11-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study