First human testing of OX118 in healthy adults

A First in Human Phase 1 Trial of OX118 in Healthy Volunteers

This test gives a single IV dose of OX118 or placebo to healthy adults aged 18–60 to see if the drug is safe and how the body handles it.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Oxion Biologics AB (Industry-sponsored)
• Locations: 1 site (Uppsala)
• Trial ID: NCT07020156 on ClinicalTrials.gov

What this trial studies

This phase 1, randomized, placebo-controlled single-ascending-dose study enrolls 32 healthy volunteers across five dose cohorts (0.1, 0.3, 1, 3, and 10 mg/kg) who receive a single IV infusion of OX118 or placebo. Sentinel dosing is used for initial participants in each cohort and an internal safety review committee must review safety data before escalating to the next dose. Participants attend seven clinic visits over roughly 91 days (including screening) and remain under close observation with at least a 24-hour in-clinic stay after dosing. Safety monitoring includes adverse events, infusion reactions, vital signs, 12-lead ECGs, labs, physical exams, and PK sampling.

Who should consider this trial

Good fit: Healthy men and women aged 18–60 with BMI 18.5–30 and weight 50–100 kg, without clinically significant medical history or abnormal screening labs/ECG, who can attend clinic visits and the required overnight stay.

Not a fit: People with active immune or other medical conditions, those outside the age/weight/BMI limits, or those seeking immediate therapeutic benefit are unlikely to gain direct clinical benefit from participation.

Why it matters

Potential benefit: If OX118 is found to be safe and shows acceptable pharmacokinetics, it could advance into patient trials and help define dosing for potential future immune-targeted treatments.

How similar studies have performed: The single-ascending-dose, sentinel-dosing format is a standard, well-established approach used successfully in many first-in-human programs, but OX118 itself has not been tested in humans before.

Eligibility criteria

Inclusion Criteria:

1. Willing and able to give written informed consent for participation in the trial.
2. Healthy male or female participant aged 18 to 60 years, inclusive.
3. 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.
4. 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.

   (Discussion is encouraged between the Investigator and the Sponsor medical representative regarding the clinical relevance of any abnormal laboratory value during the pre-dose period.)
5. 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 method of contraception with a failure rate of \<1 % to prevent pregnancy from at least 2 weeks prior to the administration of IMP to 3.5 months (15 weeks) after the last administration of IMP. In addition, any male partner of a female participant must, unless he has undergone vasectomy, agree to use a condom from the administration of IMP until 3.5 months (15 weeks) after the last administration of IMP.

The following are considered highly effective methods of contraception:

* 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 exclusive male partner who has undergone vasectomy may choose not to use contraceptives.

Women of non-childbearing potential are pre-menopausal females who have undergone any of the following surgical procedures; hysterectomy, bilateral salpingectomy or bilateral oophorectomy, or who are post-menopausal defined as 12 months of amenorrhea (in questionable cases a blood sample with detection of follicle stimulating hormone \[FSH\] \>25 IU/L is confirmatory).

Male participants must be willing to use a condom or be vasectomised or practice sexual abstinence from heterosexual intercourse (only allowed when this is the preferred and usual lifestyle of the participant) to prevent pregnancy and drug exposure of a partner and refrain from donating sperm from the first administration of IMP until 6 months after the last administration of IMP. Any female partner of a non-vasectomised male participant who is of childbearing potential must use contraceptive methods with a failure rate of \< 1% to prevent pregnancy (see above) from at least 2 weeks prior to the first administration of IMP to 3.5 months (15 weeks) after the last administration of IMP

Exclusion Criteria:

1. 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 participant's ability to participate in the trial.
2. Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the administration of IMP.
3. Malignancy within the past 5 years, with the exception of in situ removal of basal cell carcinoma.
4. Any planned major surgery within the duration of the trial.
5. Participants who are pregnant, currently breastfeeding, or intend to become pregnant during the course of the trial.
6. Any positive result at the screening visit for serum hepatitis B surface antigen, hepatitis C antibodies and/or human immunodeficiency virus (HIV).
7. 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
8. Prolonged QTcF (\>450 ms), cardiac arrhythmias or any clinically significant abnormalities in the resting ECG at the screening visit, as judged by the Investigator.
9. 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.
10. 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 paracetamol (maximum 2000 mg/day and not exceeding 3000 mg/week), as well as nasal decongestants without cortisone, antihistamine or anticholinergics for a maximum of 10 days, at the discretion of the Investigator.
11. 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.
12. Current smokers or users of nicotine products (e.g., smoking, snuffing, chewing tobacco) corresponding to ≥ 5 cigarettes per day.
13. 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 medical history and prescribed medications can be disregarded as judged by the Investigator.)
14. History of alcohol abuse or excessive intake of alcohol, as judged by the Investigator.
15. Presence or history of drug abuse, as judged by the Investigator.
16. History of, or current use of anabolic steroids, as judged by the Investigator.
17. 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.
18. Plasma donation within 1 month of screening or blood donation (or corresponding blood loss) during the last 3 months prior to screening.
19. The Investigator considers the participant unlikely to comply with trial procedures, restrictions and requirements

Where this trial is running

Uppsala

• CTC, Clinical Trial Consultants AB — Uppsala, Sweden (Recruiting)

Study contacts

• Study coordinator: Robin Fröbom, MD, PhD

Conditions Immune System