Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Phase I Study of IMP321 Given Alone or as an Adjuvant to a Reference Flu Antigen
This study has been completed.
Sponsors and Collaborators: Immutep S.A.
SGS Aster-Cephac (CRO)
Information provided by: Immutep S.A.
ClinicalTrials.gov Identifier: NCT00354263
  Purpose

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 tested: 3, 10, 30 and 100 µg). In step 1, IMP321 will be given alone and tested versus placebo (physiological saline). In step 2, the association IMP321 + Agrippal (commercially available flu vaccine) will be tested versus Agrippal alone.


Condition Intervention Phase
Healthy
Biological: IMP321
Biological: saline
Phase I

MedlinePlus related topics: Flu
Drug Information available for: Sodium chloride Influenza Vaccines Fluvirin
U.S. FDA Resources
Study Type: Interventional
Study Design: Basic Science, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Pharmacokinetics/Dynamics Study
Official Title: IMP321 Phase I Study of Four Increasing Doses (3, 10, 30 and 100 µg) of a New Immunostimulatory Factor (IMP321) Given Alone or as an Adjuvant to a Reference Flu Antigen in Healthy Young Male Volunteers

Further study details as provided by Immutep S.A.:

Primary Outcome Measures:
  • To evaluate clinical and laboratory safety and tolerability profiles [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine T cell response induction efficacy [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: April 2005
Study Completion Date: February 2006
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Placebo Comparator
PBS injected alone in step 1 or mixed with Aggripal in step 2
Biological: saline
saline injected alone in step 1 or mixed with Aggripal in step 2
B: Experimental Biological: IMP321
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 tested: 3, 10, 30 and 100 µg). In step 1, IMP321 will be given alone and tested versus placebo (physiological saline). In step 2, the association IMP321 + Agrippal (commercially available flu vaccine) will be tested versus Agrippal alone.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00354263

Locations
France
SGS Aster-Cephac
Paris, France, 75015
Sponsors and Collaborators
Immutep S.A.
SGS Aster-Cephac (CRO)
Investigators
Principal Investigator: Didier Chassard, M.D. Aster-Cephac
  More Information

Sponsor's website  This link exits the ClinicalTrials.gov site

Responsible Party: Immutep S.A. ( F. Triebel, Chief Medical Officer )
Study ID Numbers: P001, Aster-P020255
Study First Received: July 19, 2006
Last Updated: April 23, 2008
ClinicalTrials.gov Identifier: NCT00354263  
Health Authority: France: Afssaps - French Health Products Safety Agency

Keywords provided by Immutep S.A.:
Healthy male volunteers
IMP321
Adjuvant
Monotherapy
Pharmacokinetics/Pharmacodynamics

Study placed in the following topic categories:
Influenza, Human
Healthy

ClinicalTrials.gov processed this record on January 14, 2009