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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xigen SA
ClinicalTrials.gov Identifier:
NCT01570205
First received: March 29, 2012
Last updated: April 3, 2012
Last verified: April 2012
  Purpose

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


Condition Intervention Phase
Inflammation
Drug: XG-102
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Xigen SA:

Primary Outcome Measures:
  • Safety of XG-102 [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    Safety of XG-102 assessed by incidence and intensity of adverse events, clinical laboratory evaluations, vital signs, ECG, phaysical examination, ocular examination


Secondary Outcome Measures:
  • Pharmacokinetics [ Time Frame: 16 time-points up to 24 hours ] [ Designated as safety issue: No ]
    Pharmacokinetic profile will be evaluated by determination of Cmax, AUC, Half-life, Clearance , Volume of distribution


Enrollment: 24
Study Start Date: July 2011
Study Completion Date: February 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo Comparator: placebo Drug: XG-102
single intravenous infusion

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01570205

Locations
Switzerland
Covance Clinical Research
Allschwil, BS, Switzerland, 4123
Sponsors and Collaborators
Xigen SA
Investigators
Principal Investigator: Michael Seiberling, MD Covance Clinical Research
  More Information

No publications provided

Responsible Party: Xigen SA
ClinicalTrials.gov Identifier: NCT01570205     History of Changes
Other Study ID Numbers: SDD-1002-024
Study First Received: March 29, 2012
Last Updated: April 3, 2012
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014