First-in-Human Dose-escalation of GSK4425689A: Safety, Tolerability, and PK in Healthy Adults
ConditionMalaria, Falciparum
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGlaxoSmithKline
About this trial
This study will assess the safety, tolerability, and pharmacokinetic properties of GSK4425689A monoclonal antibody (mAb) in healthy adults, when administered by either intravenous (IV) or subcutaneous (SC) routes.
Eligibility criteria
Qualifiers
Participants must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
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/m².
Participants must be healthy male or female participant of non-childbearing potential (PONCBP).
Participants must be capable of giving signed informed consent prior to any study-specific procedures, which include compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Disqualifiers
Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin levels must be within the normal range at Screening.
Participants with a history of malaria infection or who have previously participated in malaria vaccine trials or studies involving experimental anti-malarial monoclonals, small molecule drugs, or experimental malaria challenge are excluded. Participants who have been vaccinated against malaria with an investigational or approved vaccine (e.g., RTS,S and R21/Matrix-M) are excluded.
History of allergy to humanized monoclonal antibodies (mAbs) or constituents of the formulation.
Any history of anaphylaxis or other severe allergic reactions, or food, or drug allergy that may impact participant safety in the opinion of the investigator.
Trial design
Treatments tested in this trial
- GSK4425689A SC
- GSK4425689A IV
- Placebo
Treatment groups
40 Participants
are divided into 5 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov