Ignite Creation Date:
2025-12-24 @ 11:21 PM
Ignite Modification Date:
2026-05-18 @ 6:53 AM
Study NCT ID:
NCT07020156
Status:
RECRUITING
Last Update Posted:
2025-06-13
First Post:
2025-04-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A First-in-Human Phase I Trial of OX118 in Healthy Volunteers
Sponsor:
Oxion Biologics AB
Organization:
Study Overview
Official Title:
A First in Human Phase 1 Trial of OX118 in Healthy Volunteers
Status:
RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
Participants will recieve either OX118 or placebo.
* 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)
Each participant is expected to take part in the trial for approximately 91 days, including an up to 28-day screening period. Participants will come for 7 visits to the research clinic for screening, treatment, and follow-up (visit 2 including two nights at the clinic).
Sentinel dosing will apply to the first 2 participants in each cohort, except for the first cohort where the first 2 participants will be dosed separately in order to maintain the blind. All Participants will remain in the trial site for 24 hours after IMP administration and will be closely monitored by medical staff. Visits at the site may be prolonged in the event that the Investigator finds it medically warranted for safety reasons.
Safety assessments
* AEs
* IRRs
* Vital signs (supine blood pressure \[BP\]), pulse, body temperature)
* 12-lead ECG
* Safety laboratory assessments (haematology, clinical chemistry and coagulation)
* Physical examinations
* Concomitant mediations
Once safety and tolerability data up until and including 7 days in the previous cohort have been collected and all participants have been dosed, all treated participants must have been reviewed by the internal safety review committee (iSRC) before a new cohort may be initiated. Based on emerging safety and tolerability, the amount of required data to be reviewed after each completed cohort may be adjusted.
* 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)
Each participant is expected to take part in the trial for approximately 91 days, including an up to 28-day screening period. Participants will come for 7 visits to the research clinic for screening, treatment, and follow-up (visit 2 including two nights at the clinic).
Sentinel dosing will apply to the first 2 participants in each cohort, except for the first cohort where the first 2 participants will be dosed separately in order to maintain the blind. All Participants will remain in the trial site for 24 hours after IMP administration and will be closely monitored by medical staff. Visits at the site may be prolonged in the event that the Investigator finds it medically warranted for safety reasons.
Safety assessments
* AEs
* IRRs
* Vital signs (supine blood pressure \[BP\]), pulse, body temperature)
* 12-lead ECG
* Safety laboratory assessments (haematology, clinical chemistry and coagulation)
* Physical examinations
* Concomitant mediations
Once safety and tolerability data up until and including 7 days in the previous cohort have been collected and all participants have been dosed, all treated participants must have been reviewed by the internal safety review committee (iSRC) before a new cohort may be initiated. Based on emerging safety and tolerability, the amount of required data to be reviewed after each completed cohort may be adjusted.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: