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melrilimab 70 milligram

Phase 1

Asthma | Monoclonal antibody | Respiratory |GSK plc|Trials Updated: Nov 5, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment65

FDA Designations

No designations recorded

melrilimab 70 milligram clinical trials

melrilimab 70 milligram · 1 trial · 2 indications

Phase 1 1
NCT04366349A Study to Evaluate the Safety and Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Melrilimab (GSK3772847) in Healthy ParticipantsHealthy Volunteers
COMPLETED65 Analytics
PHASE1COMPLETED
A Study to Evaluate the Safety and Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Melrilimab (GSK3772847) in Healthy Participants
Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
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.

Area Under the Plasma Concentration Time Curve From 0 to t (AUC[0-t]) of GSK3772847
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.

Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC[0-infinity]) of GSK3772847
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.

Maximum Observed Plasma Concentration (Cmax) of GSK3772847
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 to Cmax (Tmax) of GSK3772847
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.

Apparent Terminal Half-life (t1/2) of GSK3772847
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.

Secondary Endpoints

Maximal Decrease in Ratio to Baseline in Free Soluble Suppressor of Tumorigenicity 2 (ST2) Concentration
Baseline and up to Day 85/early withdrawal
Maximal Increase in Ratio to Baseline in Total Soluble ST2 Concentration
Baseline and up to Day 85/early withdrawal
Number of Participants With Confirmed Positive Anti-GSK3772847 Antibodies
Days 1, 15, 29, 57 and 85/early withdrawal
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Participants receiving melrilimab (GSK3772847) 70 milligram (mg)EXPERIMENTALParticipants will receive a single dose of melrilimab (GSK3772847) 70 milligram (mg) subcutaneously (SC) injection by an health care professional (HCP).
Participants receiving melrilimab (GSK3772847) 140 milligram (mg)EXPERIMENTALParticipants will receive a single dose of melrilimab (GSK3772847) 140 milligram (mg) subcutaneously (SC) injection by an health care professional (HCP).
Participants receiving PlaceboPLACEBO_COMPARATORParticipants will receive a single dose of placebo subcutaneously (SC) injection by an health care professional (HCP).

Interventions

NameTypeDescription
melrilimab (GSK3772847) 70 milligram (mg)BIOLOGICALmelrilimab (GSK3772837) will be available at a dose strength of 70 milligram per milliliter (mg/mL) in a 3 milliliter (mL) glass vial.
melrilimab (GSK3772847) 140 milligram (mg)BIOLOGICALTwo 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)
PlaceboOTHERPlacebo to match melrilimab (GSK3772847) will be available in the form of solution for injection in a 3 milliliter (mL) glass vial.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Participants age in between 18 to 65 years, at the time of signing the informed consent. * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. A participant with a c...

Countries:United States
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Frequently asked questions about melrilimab 70 milligram

What is melrilimab 70 milligram?

Melrilimab 70 milligram is a monoclonal antibody developed by GSK plc under the code GSK3772847. It is an investigational therapy being studied in asthma. The 70 milligram dose refers to a specific strength evaluated in clinical research. It has been tested in a Phase 1 trial in healthy participants.

What is melrilimab 70 milligram used for in asthma?

Melrilimab 70 milligram is being developed for the treatment of asthma. It is an investigational monoclonal antibody, and its safety, tolerability, pharmacokinetics, and pharmacodynamics have been evaluated in a Phase 1 study that included healthy volunteers and participants with asthma.

Who makes melrilimab 70 milligram?

Melrilimab 70 milligram is made by GSK plc, which trades on the New York Stock Exchange under the ticker GSK. GSK is the developer of the monoclonal antibody, also known as GSK3772847, and is responsible for its clinical development in asthma.

What phase is melrilimab 70 milligram in?

Melrilimab 70 milligram is in Phase 1 clinical development. It is an investigational monoclonal antibody and has not been approved by the FDA. The Phase 1 trial evaluating its safety, tolerability, pharmacokinetics, and pharmacodynamics has been completed.

What clinical trials is melrilimab 70 milligram in?

Melrilimab 70 milligram has been studied in one completed Phase 1 clinical trial, NCT04366349. This trial evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of melrilimab (GSK3772847) in healthy participants and involved 65 participants in the United States.

Is melrilimab 70 milligram the same as melrilimab (GSK3772847) 70 milligram?

Yes, melrilimab 70 milligram is the same as melrilimab (GSK3772847) 70 milligram. GSK3772847 is the development code for melrilimab, and the 70 milligram designation refers to the dose strength. Both names refer to the same investigational monoclonal antibody developed by GSK plc.