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Official title A First-in-Human Phase I Trial of OX118 in Healthy Volunteers
ClinicalTrials.gov ID: NCT07020156
What this study is testing
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60. Healthy volunteers may be eligible.
You may be able to join if
- 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 ≥ 50 and ≤ 100 kg and has a body mass index (BMI) ≥ 18.5 and ≤ 30.0 kg/m2 at the time of the screening visit.
- Medically healthy participant without abnormal clinically significant medical history, physical findings, vital signs, ECG and laboratory values at...
- Women of childbearing potential (WOCBP) must practice abstinence from heterosexual intercourse (only allowed when this is the preferred and usual...
You likely can't join if
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because...
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the administration of IMP.
- Malignancy within the past 5 years, with the exception of in situ removal of basal cell carcinoma.
- Any planned major surgery within the duration of the trial.
- Participants who are pregnant, currently breastfeeding, or intend to become pregnant during the course of the trial.
- Any positive result at the screening visit for serum hepatitis B surface antigen, hepatitis C antibodies and/or human immunodeficiency virus (HIV).
See the full eligibility criteria
Who can join
- 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 ≥ 50 and ≤ 100 kg and has a body mass index (BMI) ≥ 18.5 and ≤ 30.0 kg/m2 at the time of the screening visit.
- Medically healthy participant without abnormal clinically significant medical history, physical findings, vital signs, ECG and laboratory values at the time of the screening visit, as judged by the Investigator...
- Women of childbearing potential (WOCBP) must practice abstinence from heterosexual intercourse (only allowed when this is the preferred and usual lifestyle of the participant) or must agree to use a highly effective...
- combined (oestrogen and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal),
- progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable),
- intra-uterine device [IUD]or intra-uterine hormone-releasing system [IUS]). WOCBP must refrain from donating eggs from the first IMP administration until 6 months after the last IMP administration. WOCBP with an...
What rules you out
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial or influence the results or the...
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the administration of IMP.
- Malignancy within the past 5 years, with the exception of in situ removal of basal cell carcinoma.
- Any planned major surgery within the duration of the trial.
- Participants who are pregnant, currently breastfeeding, or intend to become pregnant during the course of the trial.
- Any positive result at the screening visit for serum hepatitis B surface antigen, hepatitis C antibodies and/or human immunodeficiency virus (HIV).
- After 10 minutes supine rest at the screening visit, any vital signs values outside the following ranges:
- Systolic BP: \<90 or ≥140 mmHg, or
- Diastolic BP \<50 or ≥90 mmHg, or
- Pulse \<40 or ≥90 bpm
- Prolonged QTcF (\>450 ms), cardiac arrhythmias or any clinically significant abnormalities in the resting ECG at the screening visit, as judged by the Investigator.
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to OX118.
- Regular use of any prescribed or non-prescribed medications, including antacids, analgesics, herbal remedies, vitamins and minerals, within 2 weeks prior to the administration of IMP, except occasional intake of...
- Planned treatment or treatment with another investigational drug within 3 months prior to Day -1. Participants who consented and screened but were not dosed in previous Phase I trials are not to be excluded.
- Current smokers or users of nicotine products (e.g., smoking, snuffing, chewing tobacco) corresponding to ≥ 5 cigarettes per day.
- Positive screening result for drugs of abuse or alcohol at the screening visit or on admission to the trial site prior to the administration of the IMP. (Positive results that are expected given the participant's...
- History of alcohol abuse or excessive intake of alcohol, as judged by the Investigator.
- Presence or history of drug abuse, as judged by the Investigator.
- History of, or current use of anabolic steroids, as judged by the Investigator.
- Excessive caffeine consumption defined by a daily intake of \> 5 cups (1 cup = approximately 240 mL) of caffeine-containing beverages, as judged by the Investigator.
- Plasma donation within 1 month of screening or blood donation (or corresponding blood loss) during the last 3 months prior to screening.
- The Investigator considers the participant unlikely to comply with trial procedures, restrictions and requirements
The study team makes the final eligibility decision.
Where it's taking place
- Uppsala, Sweden
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Uppsala, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.