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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 by GSK plc for the prevention of Plasmodium falciparum malaria. It is currently in Phase 1 clinical development and has not been approved by any regulatory authority. It is also known as GSK4425689A SC.
GSK4425689A is being studied for use against falciparum malaria, the most severe form of malaria caused by the Plasmodium falciparum parasite. The ongoing trial enrolls healthy adult volunteers in the United Kingdom to assess safety, tolerability, and pharmacokinetics rather than to treat active infection.
GSK4425689A is being developed by GSK plc, which trades on the New York Stock Exchange under the ticker GSK. GSK is the sole sponsor of the first-in-human study of this monoclonal antibody candidate.
GSK4425689A is in Phase 1 clinical development. It is an investigational product and has not received FDA approval or any other marketing authorization. The only trial conducted to date is a first-in-human Phase 1 study.
GSK4425689A is being evaluated in a single Phase 1 trial, NCT07646353, titled First-in-Human Dose-escalation of GSK4425689A: Safety, Tolerability, and PK in Healthy Adults. The study is currently recruiting 40 healthy adult participants in the United Kingdom and is randomized, double-blind, and controlled.
Yes, GSK4425689A SC is an alternative name for GSK4425689A. The SC designation refers to subcutaneous administration. Both names refer to the same investigational monoclonal antibody developed by GSK plc for falciparum malaria.