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

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

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

Study Overview

• Status: Completed
• Conditions: Inflammation
• Intervention / Treatment: Drug: XG-102

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Switzerland
  • BS
    • Allschwil, BS, Switzerland, 4123
      • Covance Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: XG-102; single intravenous infusion
Experimental: XG-102 10 µg/kg	Drug: XG-102; single intravenous infusion
Experimental: XG-102 40 µg/kg	Drug: XG-102; single intravenous infusion
Experimental: XG-102 80 µg/kg	Drug: XG-102; single intravenous infusion

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Xigen SA
• Investigators: Principal Investigator: Michael Seiberling, MD, Covance Clinical Research

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: March 29, 2012
• First Submitted That Met QC Criteria: April 3, 2012
• First Posted (Estimate): April 4, 2012

Study Record Updates

• Last Update Posted (Estimate): April 4, 2012
• Last Update Submitted That Met QC Criteria: April 3, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: SDD-1002-024