Phase I Study of IMP321 Given Alone or as an Adjuvant to a Reference Flu Antigen
This study has been completed.
Sponsor:
Immutep S.A.
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
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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:
|
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 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 |
Additional relevant MeSH terms:
|
Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013