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

NCT ID: NCT01570205

Last Updated: 2012-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2012-02-29

Brief Summary

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

Conditions

Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

XG-102 10 µg/kg

Group Type: EXPERIMENTAL

XG-102

Intervention Type: DRUG

single intravenous infusion

XG-102 40 µg/kg

Group Type: EXPERIMENTAL

XG-102

Intervention Type: DRUG

single intravenous infusion

XG-102 80 µg/kg

Group Type: EXPERIMENTAL

XG-102

Intervention Type: DRUG

single intravenous infusion

placebo

Group Type: PLACEBO_COMPARATOR

XG-102

Intervention Type: DRUG

single intravenous infusion

Interventions

XG-102

single intravenous infusion

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Xigen SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Seiberling, MD

Role: PRINCIPAL_INVESTIGATOR

Covance Clinical Research

Locations

Covance Clinical Research

Allschwil, Canton of Basel-City, Switzerland

Countries

Switzerland

Other Identifiers

SDD-1002-024

Identifier Type: -

Identifier Source: org_study_id