A First-in-Human Phase I Trial of OX118 in Healthy Volunteers
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.
Timeline
- Start
- 2025-04-03
- Primary completion
- 2025-10-29
- Completion
- 2025-10-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | OX118 | Monoclonal antibody | 0.1 mg/kg | Intravenous |
| Subject | OX118 | Monoclonal antibody | 0.3 mg/kg | Intravenous |
| Subject | OX118 | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | OX118 | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | OX118 | Monoclonal antibody | 10 mg/kg | Intravenous |