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

NCT07646353 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-06-12

No results posted yet for this study

Summary

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.

Conditions

  • Malaria, Falciparum

Interventions

BIOLOGICAL

GSK4425689A SC

Participants receive GSK4425689A SC.

BIOLOGICAL

GSK4425689A IV

Participants receive GSK4425689A IV.

DRUG

Placebo

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-12
Primary Completion
2028-04-19
Completion
2028-04-19

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07646353 on ClinicalTrials.gov