NCT00354263

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Immutep S.A.S. · Industry
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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 (s.c.) 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 0.5, 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.

Conditions

• Healthy

Interventions

Type	Name	Description
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.
BIOLOGICAL	saline	saline injected alone in step 1 or mixed with Aggripal in step 2

Timeline

• Start date: 2005-04-01
• Primary completion: 2005-09-01
• Completion: 2006-02-01
• First posted: 2006-07-20
• Last updated: 2008-04-24

Locations

1 site across 1 country: France