A First-in-Human Phase I Trial of OX118 in Healthy Volunteers

NCT07020156 | Recruiting Phase 1 DMC

• 1 other identifier: SAPIOX
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Immune System

Outcome Measures

Primary Outcomes (5)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Time Frame: Day 1 to Day 63]

  To evaluate the safety and tolerability of OX118 following single IV SAD administration in healthy male and female volunteers

  Day 1 to Day 63

• Number of Participants with Abnormal Vital Signs

  Day 1 to Day 63

• Number of Participants With Abnormal Laboratory Values

  Day 1 to Day 63

• Number of Participants with Abnormal Electrocardiograms (ECGs)

  Day 1 to Day 63

• Number of Participants with Abnormal Physical Examination Findings

  Day 1 to Day 63

Secondary Outcomes (9)

• AUC

  Day 1 to Day 63

• Cmax

  Day 1 to Day 63

• Tmax

  Day 1 to Day 63

• Cl

  Day 1 to Day 63

• Vz

  Day 1 to Day 63

Study Arms (5)

Experimental or placebo 0,1mg/kg (3:1)

EXPERIMENTAL

IMP: OX118 Number of participants: 4 Route of administration: intravenous infusion

Drug: OX118 or placebo

Experimental or placebo 0,3mg/kg (3:1)

EXPERIMENTAL

IMP: OX118 Number of participants: 4 Route of administration: intravenous infusion

Drug: OX118 or placebo

Experimental or placebo 1mg/kg (6:2)

EXPERIMENTAL

IMP:OX118 Number of participants: 8 Route of administration: intravenous infusion

Drug: OX118 or placebo

Experimental or placebo 3mg/kg (6:2)

EXPERIMENTAL

IMP:OX118 Number of participants: 8 Route of administration: intravenous infusion

Drug: OX118 or placebo

Experimental or placebo 10mg/kg (6:2)

EXPERIMENTAL

IMP:OX118 Number of participants: 8 Route of administration: intravenous infusion

Drug: OX118 or placebo

Interventions

OX118 or placebo DRUG

OX118 is a human monoclonal antibody targeting OX40 ligand (OX40L).

Experimental or placebo 0,1mg/kg (3:1); Experimental or placebo 0,3mg/kg (3:1); Experimental or placebo 10mg/kg (6:2); Experimental or placebo 1mg/kg (6:2); Experimental or placebo 3mg/kg (6:2)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify 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 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.)
• 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

You may not qualify if:

• 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.
• 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 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.
• 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.

Sponsors & Collaborators

• Oxion Biologics AB: lead

Study Sites (1)

CTC, Clinical Trial Consultants AB

Uppsala, 75185, Sweden

RECRUITING

Central Study Contacts

Robin Fröbom, MD, PhD

CONTACT

+46 735314059; robin.frobom@oxionbio.com

Felix Sellberg, MD, PhD

CONTACT

+46768633441; felix.sellberg@oxionbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Cohort 1: 0.1 mg/kg OX118 or placebo (3:1) Cohort 2: 0.3 mg/kg OX118 or placebo (3:1) Cohort 3: 1 mg/kg OX118 or placebo (6:2) Cohort 4: 3mg/kg OX118 or placebo (6:2) Cohort 5: 10mg/kg OX118 or placebo (6:2)

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: June 13, 2025
• Study Start: April 3, 2025
• Primary Completion: October 29, 2025
• Study Completion: October 29, 2025
• Last Updated: June 13, 2025

Record last verified: 2025-06

Locations

SE (1)