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RECRUITING
NCT07020156
PHASE1

A First-in-Human Phase I Trial of OX118 in Healthy Volunteers

Sponsor: Oxion Biologics AB

View on ClinicalTrials.gov

Summary

This is a first-in-human, phase 1 study of OX118 in healthy volunteers, designed to investigate the safety and tolerability of OX118, as well as its pharmacokinetics (the drug's concentration in the blood and excretion from the body). The study will include a total of 32 participants: healthy men and women aged 18-60 years with a body mass index (BMI) between ≥18.5 and ≤30.0.The study is divided into five cohorts where OX118 will be given as a single dose intravenously (into the blood). The study consists of 7 clinic visits taking place over a period of approximately 77 days (including a 28-day screening period). During the study, subjects will be given the study drug (OX118) or placebo. Both the study drug and the placebo will be given as a single dose as an intravenous (directly into the blood) infusion. A pre-arranged schedule will determine whether subjects will receive the study drug or the placebo.

Official title: A First in Human Phase 1 Trial of OX118 in Healthy Volunteers

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2025-04-03

Completion Date

2025-10-29

Last Updated

2025-06-13

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

OX118 or placebo

OX118 is a human monoclonal antibody targeting OX40 ligand (OX40L).

Locations (1)

CTC, Clinical Trial Consultants AB

Uppsala, Sweden