Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK4024484C · 1 trial · 1 indication
An SAE is defined as any untoward medical occurrence that 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 in the offspring of a study participant or an abnormal partner pregnancy outcome.
Mild SAE = a type of adverse event (AE) that is usually transient and may require only minimal treatment or therapeutic intervention. The event does not generally interfere with usual activities of daily living. Moderate SAE = a type of AE that is usually alleviated with additional specific therapeutic intervention. The event interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the research participant. Severe SAE = a type of AE that interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention.
An SAE is defined as any untoward medical occurrence that 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 in the offspring of a study participant or an abnormal partner pregnancy outcome.
Mild SAE = a type of AE that is usually transient and may require only minimal treatment or therapeutic intervention. The event does not generally interfere with usual activities of daily living. Moderate SAE = a type of AE that is usually alleviated with additional specific therapeutic intervention. The event interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the research participant. Severe SAE = a type of AE that interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention.
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.
Mild AE = a type of AE that is usually transient and may require only minimal treatment or therapeutic intervention. The event does not generally interfere with usual activities of daily living. Moderate AE = a type of AE that is usually alleviated with additional specific therapeutic intervention. The event interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the research participant. Severe AE = a type of AE that interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention.
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.
Mild AE = a type of AE that is usually transient and may require only minimal treatment or therapeutic intervention. The event does not generally interfere with usual activities of daily living. Moderate AE = a type of AE that is usually alleviated with additional specific therapeutic intervention. The event interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the research participant. Severe AE = a type of AE that interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention.
| Arm | Type | Description |
|---|---|---|
| 6 mg single ascending dose (SAD) Group | EXPERIMENTAL | Participants receive a 6 mg single dose of GSK4024484, in a fasted state. |
| 12 mg SAD Group | EXPERIMENTAL | Participants receive a 12 mg single dose of GSK4024484 in a fasted state. |
| 24 mg SAD Group | EXPERIMENTAL | Participants receive a 24 mg single dose of GSK4024484 in a fasted state. |
| 48 mg SAD Group | EXPERIMENTAL | Participants receive a 48 mg single dose of GSK4024484 in a fasted state. |
| 96 mg SAD Group | EXPERIMENTAL | Participants receive a 96 mg single dose of GSK4024484 in a fasted state. |
| 192 mg SAD Group | EXPERIMENTAL | Participants receive a 192 mg single dose of GSK4024484, in a fasted state. |
| Food Effect Group | EXPERIMENTAL | Participants receive a single study dose of GSK4024484 in a fed state. |
| 300 mg SAD Group | EXPERIMENTAL | Participants receive a 300 mg single dose of GSK4024484, in a fasted state. |
| 400 mg SAD Group | EXPERIMENTAL | Participants receive a 400 mg single dose of GSK4024484, in a fasted state. |
| Optional SAD Group | EXPERIMENTAL | Participants may be included in this group, to allow flexibility if the dose escalation needs modification or a dose level needs to be added or repeated. |
| Placebo SAD Group | PLACEBO_COMPARATOR | Participants receive placebo in a fed or fasted state. |
| 150 mg multiple ascending doses (MAD) Group | EXPERIMENTAL | Participants receive 150 mg per day of GSK4024484 during 3 subsequent days (450 mg total). |
| 300 mg MAD Group | EXPERIMENTAL | Participants receive 300 mg per day of GSK4024484 during 3 subsequent days (900 mg total). |
| Optional MAD Group | EXPERIMENTAL | Participants may be included in this group, to allow flexibility if the dose escalation needs modification or a dose level needs to be added or repeated. |
| Placebo MAD Group | PLACEBO_COMPARATOR | Participants receive placebo during 3 subsequent days. |
| Name | Type | Description |
|---|---|---|
| GSK4024484C | DRUG | Doses administrated orally with 240 mL of water. |
| Placebo | DRUG | Doses administrated orally with 240 mL of water. |
Inclusion Criteria: 1. Participant must be 18 to 60 years of age inclusive, at the time of signing the informed consent. 2. Participants who are considered healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac assessment. 3. A par...
GSK4024484C is an investigational small molecule being developed for the treatment of malaria, specifically Plasmodium falciparum infection. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
The molecular target of GSK4024484C has not been disclosed. It is a small molecule being studied for its safety in healthy adult participants, with the goal of assessing its potential as a treatment for falciparum malaria.
GSK4024484C is being developed by GSK plc, a global biopharmaceutical company listed on the London Stock Exchange under the ticker GSK. The company is conducting clinical trials to evaluate the safety of this investigational drug.
GSK4024484C is in Phase 1 clinical development. A Phase 1 study has been completed, and the drug remains investigational, meaning it has not yet received regulatory approval for any use.
GSK4024484C has one completed Phase 1 trial, NCT06171113, titled 'A Study to Investigate the Safety of GSK4024484 in Healthy Adult Participants.' This randomized, double-blind, placebo-controlled study enrolled 123 healthy volunteers in the United Kingdom.
GSK4024484C is closely related to GSK4024484, as the clinical trial NCT06171113 investigates the safety of GSK4024484. The 'C' suffix may denote a specific salt form or variant, but the exact relationship has not been specified.