Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
melrilimab 70 milligram · 1 trial · 2 indications
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.
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.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3772847.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3772847.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3772847.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3772847.
| Arm | Type | Description |
|---|---|---|
| Participants receiving melrilimab (GSK3772847) 70 milligram (mg) | EXPERIMENTAL | Participants 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) | EXPERIMENTAL | Participants will receive a single dose of melrilimab (GSK3772847) 140 milligram (mg) subcutaneously (SC) injection by an health care professional (HCP). |
| Participants receiving Placebo | PLACEBO_COMPARATOR | Participants will receive a single dose of placebo subcutaneously (SC) injection by an health care professional (HCP). |
| Name | Type | Description |
|---|---|---|
| melrilimab (GSK3772847) 70 milligram (mg) | BIOLOGICAL | melrilimab (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) | BIOLOGICAL | 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 | OTHER | Placebo to match melrilimab (GSK3772847) will be available in the form of solution for injection in a 3 milliliter (mL) glass vial. |
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...
Melrilimab 70 milligram is an investigational monoclonal antibody being studied in healthy volunteers. It is being developed for respiratory conditions, and the clinical trial for melrilimab lists asthma as a condition of interest. The drug is currently in Phase 1 clinical development and is not approved for any use.
Melrilimab is a monoclonal antibody, but its specific molecular target has not been disclosed in the available information. The drug is being evaluated in a Phase 1 study to assess its safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy participants.
Melrilimab is being developed by GSK plc, a pharmaceutical company traded on the stock exchange under the ticker GSK. The drug is currently in Phase 1 clinical development, and GSK is conducting a study of melrilimab in healthy volunteers in the United States.
Melrilimab is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 study of melrilimab has been completed, and the drug is being evaluated for safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy participants.
Melrilimab has one clinical trial, identified as NCT04366349, titled "A Study to Evaluate the Safety and Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Melrilimab (GSK3772847) in Healthy Participants." This Phase 1 study has been completed and enrolled 65 participants in the United States.
Yes, melrilimab is also known as GSK3772847. The clinical trial for melrilimab, NCT04366349, refers to the drug as melrilimab (GSK3772847). This alternative name is used in the study title and may appear in scientific literature or regulatory documents.