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NCT04366349 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety and Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Melrilimab (GSK3772847) in Healthy Participants
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 65
- Enrollment target
NCT04366349 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 65 participants.
The verdict
NCT04366349, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 65 participants
- Enrollment target
Study 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.
Interventions
- OTHER Placebo
- BIOLOGICAL melrilimab (GSK3772847) 70 milligram (mg)
- BIOLOGICAL melrilimab (GSK3772847) 140 milligram (mg)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2020-07-21 |
| Est. Completion | 2020-12-21 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04366349
The ClinicalTrials.gov registry entry for NCT04366349 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04366349 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04366349 about?
NCT04366349 is a clinical study titled "A Study to Evaluate the Safety and Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Melrilimab (GSK3772847) in Healthy Participants". 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 e...
What is the current status of trial NCT04366349?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2020-07-21. Estimated completion is 2020-12-21.
What interventions are being tested in trial NCT04366349?
The interventions under investigation include: Placebo (OTHER), melrilimab (GSK3772847) 70 milligram (mg) (BIOLOGICAL), melrilimab (GSK3772847) 140 milligram (mg) (BIOLOGICAL).
Who is sponsoring clinical trial NCT04366349?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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