Actively Recruiting
A First in Human Phase 1 Trial of OX118 in Healthy Volunteers
Led by Oxion Biologics AB · Updated on 2025-06-13
32
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a first-in-human phase 1 trial to study OX118, a human monoclonal antibody targeting OX40 ligand, in healthy adults aged 18 to 60 years. The trial aims to evaluate the safety, tolerability, and how the body processes OX118 when given as a single intravenous dose. This study involves 32 healthy volunteers with a body mass index between 18.5 and 30.0. Participants are divided into five groups receiving different single doses of OX118 or a placebo by intravenous infusion. The doses range from 0.1 mg/kg to 10 mg/kg, with participants randomized to receive either the drug or placebo based on a pre-arranged schedule. The trial includes sentinel dosing for initial participants in each group, and all participants stay at the clinic for at least 24 hours after dosing for monitoring. Each participant will attend 7 clinic visits over about 91 days, including a 28-day screening period. Visits include treatment administration, safety assessments such as vital signs, ECGs, physical exams, laboratory tests, and monitoring for adverse events. Safety data is reviewed by an internal committee before moving to the next dosing group. Researchers will measure adverse events, vital signs, lab results, ECG changes, and physical exam findings from Day 1 to Day 63, along with drug concentration and immune response data.
CONDITIONS
Brief 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 for participation in the trial.
- Healthy male or female participant aged 18 to 60 years, inclusive.
- Weighs between 50 and 100 kg with a body mass index (BMI) between 18.5 and 30.0 kg/m2.
- Medically healthy without clinically significant medical history, abnormal physical findings, vital signs, ECG, or lab values at screening.
- Women of childbearing potential must agree to use highly effective contraception or abstinence starting 2 weeks before to 15 weeks after last study drug administration.
- Male participants must use condoms, be vasectomised, or practice sexual abstinence during the same period to prevent pregnancy and drug exposure.
- Women of non-childbearing potential defined by surgical procedures or post-menopausal status.
- Participants must comply with trial procedures and restrictions.
You will not qualify if you...
- History of any clinically significant disease or disorder that increases risk or affects participation.
- Illness, medical/surgical procedure, or trauma within 4 weeks before study drug administration.
- Malignancy within 5 years except treated basal cell carcinoma.
- Planned major surgery during the trial.
- Pregnant, breastfeeding, or planning pregnancy during the trial.
- Positive screening for hepatitis B, hepatitis C, or HIV.
- Abnormal vital signs outside specified ranges after 10 minutes rest.
- Prolonged QTcF, cardiac arrhythmias, or significant ECG abnormalities.
- History or ongoing severe allergy or hypersensitivity to similar drugs.
- Regular use of prescribed or non-prescribed medications within 2 weeks before dosing, except limited allowed medications.
- Treatment with another investigational drug within 3 months prior.
- Current smokers or nicotine product users of 5 or more cigarettes daily.
- Positive drug or alcohol screening at visits.
- History of alcohol or drug abuse.
- Use of anabolic steroids.
- Excessive caffeine intake over 5 cups daily.
- Recent plasma or blood donation within specified time frames.
- Investigator considers participant unlikely to comply with trial requirements.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - Up to 28 days
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive a single intravenous infusion of OX118 or placebo and remain at the clinic for monitoring.
1 visit including a 2-night stay at the clinic
Duration - Up to 62 days after treatment
Participants are monitored for safety and tolerability with visits for assessments including adverse events, vital signs, ECG, laboratory tests, and physical examinations.
Approximately 5 follow-up visits (in-person)
Trial Site Locations
Total: 1 location
1
CTC, Clinical Trial Consultants AB
Uppsala, Sweden, 75185
Actively Recruiting
Research Team
R
Robin Fröbom, MD, PhD
F
Felix Sellberg, MD, PhD
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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