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NCT07020156

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

Recruiting now Phase 1 Last updated 13 June 2025
What this trial tests

Phase 1 trial testing OX118 or placebo in Immune System in 32 participants. Currently enrolling.

Timeline
3 April 2025
Primary endpoint
29 October 2025
29 October 2025

Quick facts

Lead sponsorOxion Biologics AB
PhasePhase 1
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designsequential
Maskingtriple
Primary purposetreatment
Enrollment32
Start date3 April 2025
Primary completion29 October 2025
Estimated completion29 October 2025
Sites1 location across Sweden

Drugs / interventions tested

Conditions studied

Sponsor

Oxion Biologics AB — full company profile →

Who can join

Adults 18 to 60, any sex, with Immune System. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Tolerance Induction Strategies in Organ Transplantation: Current Status and Future Perspectives.
    Blein T, Ayas N, Charbonnier S, Gil A, et al · · 2025 · cited 2× · PMID 41127478 · DOI 10.3389/ti.2025.14958

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07020156.

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