Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04366349 | A Study to Evaluate the Safety and Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Melrilimab (GSK3772847) in Healthy Participants | PHASE1 | COMPLETED | 65 | — | — | Jul 21, 2020 | Dec 21, 2020 | Nov 5, 2021 | 1 | United States |
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...