The purpose of this study is to evaluate the safety, tolerability and immunogenicity of rAAV1-PG9DP when administered intramuscularly at different dose levels in healthy male adults.
This study is a phase 1, randomized, blinded, dose-escalation study to evaluate the safety and tolerability of rAAV1-PG9DP when administered intramuscularly at 4x10\^12 vg, 4x10\^13 vg, 8x10\^13 vg and 1.2x10\^14 vg in healthy male adults. Volunteers will be screened up to 42 days before injection and will be followed for 12 months after the single administration. It is anticipated that it will take approximately 13 months to enroll the study. Volunteers will be randomly assigned investigational product (IP) or placebo within each of the dose groups described in the study design table above depending on which group is enrolling. Study staff and volunteers will be blinded only with respect to the allocation of placebo or IP. Blinding will not apply to the assignment of dosage levels. Volunteers will be offered enrollment into a follow-up study at the research center when they have finished participating in the trial
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
21
4x10\^12 vg administered intramuscularly
4x10\^13 vg administered intramuscularly
8x10\^13 vg administered intramuscularly
Surrey Clinical Research Centre
Guildford, United Kingdom
Southampton Centre for Biomedical Research
Southampton, United Kingdom
Safety and Tolerability
1. Proportion of volunteers with moderate or greater reactogenicity (i.e., solicited adverse events) during a 7 day follow-up period after the injection 2. Proportion of volunteers with moderate or greater adverse events (i.e. unsolicited adverse events) including safety laboratory (biochemical, haematological) parameters, from the day of the injection up to 180 days post injection 3. Proportion of volunteers with serious adverse events (SAEs) related to the IMP throughout the study period 4. The proportion of volunteers in each group with Adverse Event of Special Interest, defined as adverse events potentially caused by antigen-antibody complexes or immune responses directed to cells producing the transgene
Time frame: 12 months
Pharmacokinetics and Immunogenicity
To assess (qualitative and quantitative) immune responses elicited by the different dose levels.
Time frame: 12 months
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1.2x10\^14 vg administered intramuscularly