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First-in-Human Dose-escalation of GSK4425689A: Safety, Tolerability, and PK in Healthy Adults

ConditionMalaria, Falciparum
Trial statusRecruiting
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

This trial accepts healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • GSK4425689A SC

    Biological/Vaccine

    Participants receive GSK4425689A SC.

  • GSK4425689A IV

    Biological/Vaccine

    Participants receive GSK4425689A IV.

  • Placebo

    Drug

    Participants receive Placebo in the same volume and route as the participants receiving GSK4425689A in the same cohort.

Treatment groups

40 Participants
are divided into 5 treatment groups
Group A: GSK4425689A Low Dose SC GroupExperimental treatment 2 interventions
Group B: GSK4425689A Low Dose IV GroupExperimental treatment 2 interventions
Group C: GSK4425689A Medium Dose SC GroupExperimental treatment 2 interventions
Group D: GSK4425689A Medium Dose IV GroupExperimental treatment 2 interventions
Group E: GSK4425689A High Dose IV GroupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of participants with adverse events (AEs) overall and by severity

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.

Time frame
From Day 1 up to Day 364
2

Number of participants with serious adverse events (SAEs) overall and by 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.

Time frame
From Day -28 [informed consent form (ICF) signing] up to Day 364

Secondary outcomes

1

Bioavailability (F) of SC administration

Time frame
From Day 1 until Day 197 [samples taken at pre-dose (within 1 hour) and at approximately 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose
2

Terminal serum half-life (t1/2)

Time frame
From Day 1 until Day 197 [samples taken at pre-dose (within 1 hour) and at approximately 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose
3

Clearance (CL) of IV administration and apparent clearance (CL/F) of SC administration

Time frame
From Day 1 until Day 197 [samples taken at pre-dose (within 1 hour) and at approximately 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose
4

Volume of distribution (Vd) of IV administration and apparent volume of distribution (Vd/F) of SC administration

Time frame
From Day 1 until Day 197 [samples taken at pre-dose (within 1 hour) and at approximately 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose

Other outcomes

Sponsors and contacts

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GlaxoSmithKline

Lead sponsor

Source ClinicalTrials.gov
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