Phase I Study of IMP321 Given Alone or as an Adjuvant to a Reference Flu Antigen

This study has been completed.
Sponsor:
Collaborator:
SGS Aster-Cephac (CRO)
Information provided by:
Immutep S.A.
ClinicalTrials.gov Identifier:
NCT00354263
First received: July 19, 2006
Last updated: April 23, 2008
Last verified: April 2008
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
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

Resource links provided by NLM:


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
Placebo Comparator: A
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
Experimental: B 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.
Other Names:
  • hLAG-3Ig
  • CD223
  • LAG-3

  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
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: 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

Additional Information:
No publications provided

Responsible Party: F. Triebel, Chief Medical Officer, Immutep S.A.
ClinicalTrials.gov Identifier: NCT00354263     History of Changes
Other Study ID Numbers: P001, Aster-P020255
Study First Received: July 19, 2006
Last Updated: April 23, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on October 23, 2014