Safety, Tolerability and PK of a Single iv Infusion of 10, 40, and 80 µg/kg XG-102 Administered to Healthy Volunteers

Study Overview
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Brief Summary
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The objective of the study is to investigate safety, tolerability, and pharmacokinetics of XG-102 following iv infusion of single escalating dose of 10, 40, and 80 µg/kg XG-102 to healthy male volunteers

Official Title
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The Safety, Tolerability and Pharmacokinetics of a Single Intravenous Infusion of 10, 40, and 80 µg/kg XG-102 Administered to Healthy Male Volunteers in a Randomized, Double Blind, Placebo Controlled, Dose Escalating Phase I Study

Conditions
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Inflammation

Intervention / Treatment
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* Drug: XG-102


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male volunteers Age ≥ 18 to ≤ 45 years BP: 100 - 150 mm Hg systolic, 50 - 95 mm Hg diastolic and pulse rate: 50 - 100 bpm. Body mass index between 18.5 and 30.0 kg/m2 and body weight in the 50 - 100 kg range. Are able to communicate and co-operate with the Investigator and his/her staff Healthy on the basis of medical history, physical examination findings, clinical laboratory test results, vital sign measurements, and digital 12 lead ECG readings Written informed consent obtained Male subjects with partners of childbearing potential have to use adequate contraception during, and for at least the four weeks after administration of study medication. Exclusion Criteria: Heavy smokers, i.e. more than 10 cigarettes per day Participation in a clinical trial during the previous 4 weeks Loss of 500 mL blood or more during the 3 month period before the screening visit of the study Existence of any surgical or medical condition which might relevantly interfere with the subject safety, the distribution, metabolism or excretion of the drug or the study assessments, i.e. impaired renal or hepatic function, diabetes mellitus, thyroid function abnormalities including abnormal thyroid hormone values in the Screening evaluation, cardiovascular abnormalities, chronic symptoms of pronounced constipation or diarrhea or conditions associated with total or partial obstruction of the urinary tract. History of alcohol or drug abuse in the last 3 years. Positive results of the drug Screening. Clinically significant abnormal laboratory values at the Screening or baseline evaluation. A history of any serious adverse reaction or hypersensitivity to any drug or other medicines Presence or history of any allergy requiring acute or chronic treatment (seasonal allergic rhinitis which requires no treatment may be tolerated). Positive results from serology examination for HBV, HCV, HIV or tuberculosis History of serious mental disorders. Need of any prescription medication within 30 days prior to the administration of the drug and/or nonprescription medication within 7 days prior to the administration of the drug or anticipated need for any concomitant medication during the study. Volunteers who are unwilling to comply with the provisions of this protocol Symptoms of a significant (upon Investigator's medical judgment) somatic or mental illness in the two week period preceding drug administration.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: XG-102 10 µg/kg<br> | Drug: XG-102<br>* single intravenous infusion<br>|
| Experimental: XG-102 40 µg/kg<br> | Drug: XG-102<br>* single intravenous infusion<br>|
| Experimental: XG-102 80 µg/kg<br> | Drug: XG-102<br>* single intravenous infusion<br>|
| Placebo Comparator: placebo<br> | Drug: XG-102<br>* single intravenous infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of XG-102 | Safety of XG-102 assessed by incidence and intensity of adverse events, clinical laboratory evaluations, vital signs, ECG, phaysical examination, ocular examination | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics | Pharmacokinetic profile will be evaluated by determination of Cmax, AUC, Half-life, Clearance , Volume of distribution | 16 time-points up to 24 hours |