Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00354263
Status:
COMPLETED
Last Update Posted:
2008-04-24
First Post:
2006-07-19
Brief Title:
Phase I Study of IMP321 Given Alone or as an Adjuvant to a Reference Flu Antigen
Sponsor:
Immutep SAS
Organization:
Immutep SAS
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2008-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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 be evaluated versus a placebo group of 4 subjects
Group IMP321 alone at 3 µg
Group IMP321 alone at 10 µg
Group IMP321 alone at 30 µg
Group IMP321 alone at 100 µg
In order to complete these groups four successive cohorts of volunteers will be studied
Cohort A will correspond to the dose 3 µg and will include
4 subjects treated by IMP321 3 µg alone
1 subject treated by placebo
If the tolerability of this cohort is acceptable the following cohort will be done
Cohort B will correspond to the dose 10 µg and will include
4 subjects treated by IMP321 10 µg alone
1 subject treated by placebo
If the tolerability of this cohort is acceptable the following cohort will be dose
Cohort C will correspond to the dose 30 µg and will include
4 subjects treated by IMP321 30 µg alone
1 subject treated by placebo
If the tolerability of this cohort is acceptable the following cohort will be done
Cohort D will correspond to the dose 100 µg and will include
4 subjects treated by IMP321 100 µg alone
1 subject treated by placebo
Step 2 40 volunteers The association IMP321 Agrippal will be tested versus the Agrippal alone
In this second step 4 group doses of eight subjects each will be evaluated versus a reference group Agrippal physiological saline of 8 subjects
Group Agrippal 3 µg of IMP321
Group Agrippal 10 µg of IMP321
Group Agrippal 30 µg of IMP321
Group Agrippal 100 µg of IMP321
In order to complete these groups four successive cohorts of volunteers will be studied
Cohort A will correspond to the dose 3 µg of IMP321 and will include
8 subjects treated by Agrippal IMP321 3 µg
2 subjects treated by Agrippal physiological saline
If the tolerability of this cohort is acceptable the following cohort will be done
Cohort B will correspond to the dose 10 µg of IMP321 and will include
8 subjects treated by Agrippal IMP321 10 µg
2 subjects treated by Agrippal physiological saline
If the tolerability of this cohort is acceptable the following cohort will be done
Cohort C will correspond to the dose 30 µg of IMP321 and will include
8 subjects treated by Agrippal IMP321 30 µg
2 subjects treated by Agrippal physiological saline
If the tolerability of this cohort is acceptable the following cohort will be done
Cohort D will correspond to the dose 100 µg of IMP321 and will include
8 subjects treated by Agrippal IMP321 100 µg
2 subjects treated by Agrippal physiological saline
This study will be 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 Treatments will be administered as a subcutaneous injection on the mornings of Day 1 The injection will be done subcutaneously sc in the deltoid area of the non dominant arm
The pharmacokinetic analysis will be performed by IMP321-specific ELISA testing of the samples collected from the 4 volunteers receiving 100 µg IMP321 alone Blood samples will be taken on the morning of Day 1 before dosing then at 05 1 4 24 and 48 h after dosing
Blood samples for T cell assays and serum samples for hLAG-3Ig- and HA-specific antibody detection by ELISA will be taken on the morning of Days 1 29 and 57
Monitoring for the occurrence of adverse events AE changes in physical examination vital signs blood pressure pulse rate respiration electrocardiograms ECG and clinical laboratory tests biochemistry haematology urinalysis will be performed before and after each dose of the study drug to assess safety and tolerability
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 be evaluated versus a placebo group of 4 subjects
Group IMP321 alone at 3 µg
Group IMP321 alone at 10 µg
Group IMP321 alone at 30 µg
Group IMP321 alone at 100 µg
In order to complete these groups four successive cohorts of volunteers will be studied
Cohort A will correspond to the dose 3 µg and will include
4 subjects treated by IMP321 3 µg alone
1 subject treated by placebo
If the tolerability of this cohort is acceptable the following cohort will be done
Cohort B will correspond to the dose 10 µg and will include
4 subjects treated by IMP321 10 µg alone
1 subject treated by placebo
If the tolerability of this cohort is acceptable the following cohort will be dose
Cohort C will correspond to the dose 30 µg and will include
4 subjects treated by IMP321 30 µg alone
1 subject treated by placebo
If the tolerability of this cohort is acceptable the following cohort will be done
Cohort D will correspond to the dose 100 µg and will include
4 subjects treated by IMP321 100 µg alone
1 subject treated by placebo
Step 2 40 volunteers The association IMP321 Agrippal will be tested versus the Agrippal alone
In this second step 4 group doses of eight subjects each will be evaluated versus a reference group Agrippal physiological saline of 8 subjects
Group Agrippal 3 µg of IMP321
Group Agrippal 10 µg of IMP321
Group Agrippal 30 µg of IMP321
Group Agrippal 100 µg of IMP321
In order to complete these groups four successive cohorts of volunteers will be studied
Cohort A will correspond to the dose 3 µg of IMP321 and will include
8 subjects treated by Agrippal IMP321 3 µg
2 subjects treated by Agrippal physiological saline
If the tolerability of this cohort is acceptable the following cohort will be done
Cohort B will correspond to the dose 10 µg of IMP321 and will include
8 subjects treated by Agrippal IMP321 10 µg
2 subjects treated by Agrippal physiological saline
If the tolerability of this cohort is acceptable the following cohort will be done
Cohort C will correspond to the dose 30 µg of IMP321 and will include
8 subjects treated by Agrippal IMP321 30 µg
2 subjects treated by Agrippal physiological saline
If the tolerability of this cohort is acceptable the following cohort will be done
Cohort D will correspond to the dose 100 µg of IMP321 and will include
8 subjects treated by Agrippal IMP321 100 µg
2 subjects treated by Agrippal physiological saline
This study will be 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 Treatments will be administered as a subcutaneous injection on the mornings of Day 1 The injection will be done subcutaneously sc in the deltoid area of the non dominant arm
The pharmacokinetic analysis will be performed by IMP321-specific ELISA testing of the samples collected from the 4 volunteers receiving 100 µg IMP321 alone Blood samples will be taken on the morning of Day 1 before dosing then at 05 1 4 24 and 48 h after dosing
Blood samples for T cell assays and serum samples for hLAG-3Ig- and HA-specific antibody detection by ELISA will be taken on the morning of Days 1 29 and 57
Monitoring for the occurrence of adverse events AE changes in physical examination vital signs blood pressure pulse rate respiration electrocardiograms ECG and clinical laboratory tests biochemistry haematology urinalysis will be performed before and after each dose of the study drug to assess safety and tolerability
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Aster-P020255 | None | None | None |