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Also known as GSK4425689A SC
GSK4425689A · 1 trial · 1 indication
An AE is defined as 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. Grades are defined based on numeric criteria as follows Grade 1: mild; Grade 2: moderate; Grade 3: severe. Higher grades indicate greater severity.
An SAE is defined as any untoward medical . occurrence that results in death, is life- . threatening, requires inpatient hospitalization or extends existing hospitalization, causes . persistent or significant disability/incapacity, involves a congenital anomaly/birth defect in a participants offspring, includes an abnormal . pregnancy outcome, or occurs in any other . situation per the investigators judgement. Grades are defined based on numeric criteria as follows Grade 1: mild; Grade 2: moderate; Grade 3: severe. Higher grades indicate greater severity.
| Arm | Type | Description |
|---|---|---|
| GSK4425689A Low Dose SC Group | EXPERIMENTAL | Participants receive a low dose of GSK4425689A subcutaneously (SC) on Day 1. |
| GSK4425689A Low Dose IV Group | EXPERIMENTAL | Participants receive a low dose of GSK4425689A intravenously (IV) on Day 1. |
| GSK4425689A Medium Dose SC Group | EXPERIMENTAL | Participants receive a medium dose of GSK4425689A SC on Day 1. |
| GSK4425689A Medium Dose IV Group | EXPERIMENTAL | Participants receive a medium dose of GSK4425689A IV on Day 1. |
| GSK4425689A High Dose IV Group | EXPERIMENTAL | Participants receive a high dose of GSK4425689A IV on Day 1. |
| Name | Type | Description |
|---|---|---|
| GSK4425689A SC | BIOLOGICAL | Participants receive GSK4425689A SC. |
| GSK4425689A IV | BIOLOGICAL | Participants receive GSK4425689A IV. |
| Placebo | DRUG | Participants receive Placebo in the same volume and route as the participants receiving GSK4425689A in the same cohort. |
Inclusion Criteria: 1. Participants must be 18 to 65 years of age inclusive, at the time of signing the informed consent. 2. Participants must have a body weight between 50 and 100 kg, inclusive and body-mass index (BMI) within the range of 18.0 to 32.0 kg/m\^2. 3. Participants must be healthy male...
GSK4425689A is an investigational monoclonal antibody being developed for the prevention or treatment of falciparum malaria, a form of malaria caused by the Plasmodium falciparum parasite. It is currently in Phase 1 clinical development and is not yet approved for any use.
GSK4425689A is being developed by GSK plc, a global biopharmaceutical company listed on the London Stock Exchange under the ticker GSK. The company is conducting a first-in-human trial to evaluate the drug's safety, tolerability, and pharmacokinetics in healthy adults.
GSK4425689A is in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. A first-in-human dose-escalation study is planned to assess its safety, tolerability, and pharmacokinetic profile in healthy adult volunteers.
GSK4425689A is being studied in a single Phase 1 clinical trial registered as NCT07646353. This first-in-human study is a randomized, double-blind, controlled dose-escalation trial designed to evaluate the safety, tolerability, and pharmacokinetics of GSK4425689A in healthy adults. The trial is not yet recruiting participants.
Yes, GSK4425689A SC is another name for GSK4425689A. The SC designation likely refers to the subcutaneous route of administration, but both names refer to the same investigational monoclonal antibody being developed by GSK plc for falciparum malaria.