Actively Recruiting
A First-in-Human Phase I Trial of OX118 in Healthy Volunteers
Led by Oxion Biologics AB · Updated on 2025-06-13
32
Participants Needed
1
Research Sites
29 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A First-in-Human Phase I Trial of OX118 in Healthy Volunteers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to give written informed consent
- Healthy male or female aged 18 to 60 years
- Weight between 50 and 100 kg with BMI between 18.5 and 30.0 kg/m2 at screening
- Medically healthy with no significant medical history, physical findings, vital signs, ECG, or lab abnormalities
- Women of childbearing potential must use effective contraception or abstain from heterosexual intercourse as preferred
- Male participants must use condoms or be vasectomised to prevent pregnancy exposure
- Women of non-childbearing potential include pre-menopausal females with surgical sterilization or post-menopausal status
You will not qualify if you...
- History of any significant disease or disorder that may affect safety or trial results
- Any illness, surgery, or trauma within 4 weeks before dosing
- History of malignancy in past 5 years except basal cell carcinoma removal
- Planned major surgery during the trial
- Pregnant, breastfeeding, or intending pregnancy during trial
- Positive screening for hepatitis B, hepatitis C, or HIV
- Abnormal vital signs outside specified blood pressure or pulse ranges at screening
- Prolonged QTcF, cardiac arrhythmias, or significant ECG abnormalities
- History or ongoing severe allergy or hypersensitivity to similar drugs
- Regular use of medications within 2 weeks prior to dosing except limited exceptions
- Use of investigational drugs within 3 months prior to dosing
- Current smokers or nicotine users of 5 or more cigarettes per day
- Positive screening for drugs of abuse or alcohol
- History of alcohol or drug abuse or anabolic steroid use
- Excessive caffeine intake over 5 cups per day
- Recent plasma or blood donation within specified timeframes
- Investigator judgment of unlikely compliance with trial procedures
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
CTC, Clinical Trial Consultants AB
Uppsala, Sweden, 75185
Actively Recruiting
Research Team
R
Robin Fröbom, MD, PhD
CONTACT
F
Felix Sellberg, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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