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NCT03965533COMPLETEDanonymous

A Randomised, Double-blind, Placebo-controlled Phase I Study of the Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Intravenous Dose of GSK2831781 in Healthy Japanese and Caucasian Participants, and a Single Subcutaneous Dose of GSK2831781 in Healthy Caucasian Participants

Sponsor

Source record

GlaxoSmithKline

Phase

Source record

PHASE1

Modality

AI-normalized

small molecule

Target

AI-normalized

GSK2831781, Placebo

Indication / condition

AI-normalized

Healthy Volunteers

Intervention

Source record

GSK2831781, Placebo

Source & freshness

Source record

NCT ID

NCT03965533

Original source

ClinicalTrials.gov

Source last updated

Nov 18, 2020

Ingested at

Jun 11, 2026

Internal sync

Jun 11, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

Open original registry record
View original source fields

NCT ID

NCT03965533

Title

A Randomised, Double-blind, Placebo-controlled Phase I Study of the Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Intravenous Dose of GSK2831781 in Healthy Japanese and Caucasian Participants, and a Single Subcutaneous Dose of GSK2831781 in Healthy Caucasian Participants

Sponsor

GlaxoSmithKline

Status

COMPLETED

Phase

PHASE1

Condition raw

Healthy Volunteers

Condition normalized

Healthy Volunteers

Modality raw

small molecule

Modality normalized

small molecule

Target raw

GSK2831781, Placebo

Target normalized

GSK2831781, Placebo

Interventions

GSK2831781, Placebo

Public preview

Source record

This is a double-blind, placebo-controlled, randomized, parallel group, two-part study where single IV doses of GSK2831781 will be administered to healthy Japanese and Caucasian subjects in part A and SC doses will be administered to healthy Caucasian subjects in part B. GSK2831781 is a humanized, antibody-dependent cell cytotoxicity (ADCC) enhanced depleting monoclonal antibody that is specific to the lymphocyte activation gene-3 (LAG3) protein. LAG3 is a transmembrane receptor, which is upregulated on T cells following activation. The objective of the study is to assess the safety, tolerability, PK, PD and immunogenicity post administration of GSK2831781 in healthy subjects. The duration of the study is approximately 147 days for each subject enrolled. Approximately 36 subjects will be enrolled in the study, 16 subjects in Part A and 20 subjects in Part B.

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