Status:
COMPLETED
Phase I Study of IMP321 Given Alone or as an Adjuvant to a Reference Flu Antigen
Lead Sponsor:
Immutep S.A.S.
Collaborating Sponsors:
SGS Aster-Cephac (CRO)
Conditions:
Healthy
Eligibility:
MALE
18-40 years
Phase:
PHASE1
Brief Summary
This study is a single centre, single blind, placebo (step 1) or reference (step 2) randomised study. Healthy young male volunteers will receive single ascending dose of IMP321 in each step (4 doses t...
Detailed Description
This study is divided in two steps: Step 1 (20 volunteers): IMP321 will be given alone and tested versus placebo (physiological saline) In this first step, 4 group doses (of four subjects each) will...
Eligibility Criteria
Inclusion
- able to give a written informed consent ;
- healthy male volunteers aged between 18 and 40 years;
- with body mass index (weight/height²) in the range 18 to 30 kg/m²;
- registered with the French Social Security in agreement with the French Law (Huriet Law : N° 88.1138 - 20.12.88) on biomedical experimentation;
- able to comply with protocol requirements, including blood and urine sample collections as defined in the protocol;
- not flu vaccination in the last two years.
Exclusion
- who on direct questioning and physical examination have evidence of any clinically significant acute or chronic disease, including known or suspected HIV, HBV and HCV infection ;
- with any clinically significant abnormality following review of pre-study laboratory tests and full physical examination ;
- who have received any experimental drug within the exclusion period defined in the National Register for Healthy Volunteers of the French Ministry of Health ;
- who forfeit their freedom by administrative or legal award or who were under guardianship ;
- unwilling to give their informed consent ;
- who present a positive laboratory test for Hepatitis B surface antigen (HbsAg), HBc antibodies, HIV 1 and 2 antibodies and HCV antibodies ;
- who have a history of allergy or intolerance to the study drug ;
- who had a history of serious allergy, asthma, allergic skin rash or sensitivity to any drug ;
- who are known or suspected alcohol or drug abusers ;
- who present a positive laboratory test for urine drug screening (opiates, barbiturates, amphetamine, cannabis) ;
- who undergo surgery or have donated blood within 1 month prior to the start of the study ;
- who have taken any prescribed or over the counter drug (including antacid drug), with the exception of paracetamol (up to 3 g per day) within 1 week prior to the first dose administration ;
- who receive any drug known to affect hepatic metabolism like cimetidine, ketoconazole, fluconazole, itraconazole, phenytoin, rifampicin, rifabutin within 1 month prior to the first dose administration ;
- who receive any drug known to affect renal tubular secretion like probenecid, beta-lactam antibiotics within 2 weeks prior to the first dose administration ;
- who present any clinical condition or prior therapy which, in the opinion of the investigator, made the subject unsuitable for the study.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2006
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00354263
Start Date
April 1 2005
End Date
February 1 2006
Last Update
April 24 2008
Active Locations (1)
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1
SGS Aster-Cephac
Paris, France, 75015