A First-in-Human Phase I Trial of OX118 in Healthy Volunteers
ConditionImmune System
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorOxion Biologics AB
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
OX118 or placebo
DrugOX118 is a human monoclonal antibody targeting OX40 ligand (OX40L).
Treatment groups
32 Participants
are divided into 5 treatment groupsGroup A: Experimental or placebo 0,1mg/kg (3:1)Experimental treatment 1 intervention
Group B: Experimental or placebo 0,3mg/kg (3:1)Experimental treatment 1 intervention
Group C: Experimental or placebo 1mg/kg (6:2)Experimental treatment 1 intervention
Group D: Experimental or placebo 3mg/kg (6:2)Experimental treatment 1 intervention
Group E: Experimental or placebo 10mg/kg (6:2)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Day 1 to Day 632
Number of Participants with Abnormal Vital Signs
Time frame
Day 1 to Day 633
Number of Participants With Abnormal Laboratory Values
Time frame
Day 1 to Day 634
Number of Participants with Abnormal Electrocardiograms (ECGs)
Time frame
Day 1 to Day 63Secondary outcomes
1
AUC
Area under the plasma concentration vs. time curve (AUC).
Time frame
Day 1 to Day 632
Cmax
Maximum plasma concentration (Cmax).
Time frame
Day 1 to Day 633
Tmax
Time to Cmax (Tmax).
Time frame
Day 1 to Day 634
Cl
Clearance.
Time frame
Day 1 to Day 63Sponsors and contacts
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Source ClinicalTrials.gov