Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01397604 | The Effects of GLA on Human Volunteers | PHASE1 | COMPLETED | 32 | — | — | Jul 1, 2011 | Mar 1, 2013 | Sep 23, 2013 | 1 | United States |
Local reactogenicity events and systemic reactogenicity events will be monitored. Local reactogenicity events:Moderate significant events include, but are not limited to, pain, tenderness, erythema, skin discoloration, edema, vesicle formation or ulceration, induration, pruritus, and formation of a crust or scab. • Systemic reactogenicity events: Include fever, chills, headache, nausea, vomiting, malaise, myalgia, arthralgia, and rash.
| Arm | Type | Description |
|---|---|---|
| Saline Placebo | NO_INTERVENTION | The trial will consist of a total of 32 people. An over-enrollment of about 10% (3 volunteers) will be permitted. Each cohort will be recruited in sequence. Cohort I will include 16 subjects that will receive a subcutaneous injection, randomized equally so that 5 individuals will receive GLA-AF (2µg), 5 individuals will receive GLA-SE, 3 individuals will receive saline placebo and 3 individuals will receive SE vehicle. Cohort II will include 16 subjects that will receive intramuscular injections, randomized equally into 5 GLA-AF (2µg) subjects, 5 GLA-SE (2µg) subjects, 3 saline placebo subjects and 3 SE vehicle control subjects. |
| SE Vehicle | PLACEBO_COMPARATOR | The trial will consist of a total of 32 people. An over-enrollment of about 10% (3 volunteers) will be permitted. Each cohort will be recruited in sequence. Cohort I will include 16 subjects that will receive a subcutaneous injection, randomized equally so that 5 individuals will receive GLA-AF (2µg), 5 individuals will receive GLA-SE, 3 individuals will receive saline placebo and 3 individuals will receive SE vehicle. Cohort II will include 16 subjects that will receive intramuscular injections, randomized equally into 5 GLA-AF (2µg) subjects, 5 GLA-SE (2µg) subjects, 3 saline placebo subjects and 3 SE vehicle control subjects. The SE (squalene) vehicle contains the oil emulsion in which the GLA-SE is solubilized. |
| GLA-AF | ACTIVE_COMPARATOR | The trial will consist of a total of 32 people. An over-enrollment of about 10% (3 volunteers) will be permitted. Each cohort will be recruited in sequence. Cohort I will include 16 subjects that will receive a subcutaneous injection, randomized equally so that 5 individuals will receive GLA-AF (2µg), 5 individuals will receive GLA-SE, 3 individuals will receive saline placebo and 3 individuals will receive SE vehicle. Cohort II will include 16 subjects that will receive intramuscular injections, randomized equally into 5 GLA-AF (2µg) subjects, 5 GLA-SE (2µg) subjects, 3 saline placebo subjects and 3 SE vehicle control subjects. GLA-AF contains the study drug in an aqueous solution. |
| GLA-SE | ACTIVE_COMPARATOR | The trial will consist of a total of 32 people. An over-enrollment of about 10% (3 volunteers) will be permitted. Each cohort will be recruited in sequence. Cohort I will include 16 subjects that will receive a subcutaneous injection, randomized equally so that 5 individuals will receive GLA-AF (2µg), 5 individuals will receive GLA-SE, 3 individuals will receive saline placebo and 3 individuals will receive SE vehicle. Cohort II will include 16 subjects that will receive intramuscular injections, randomized equally into 5 GLA-AF (2µg) subjects, 5 GLA-SE (2µg) subjects, 3 saline placebo subjects and 3 SE vehicle control subjects. GLA-SE contains the study drug in a squalene oil emulsion. |
| Name | Type | Description |
|---|---|---|
| GLA-AF | DRUG | GLA-AF contains GLA, a new synthetic lipid A molecule that combines 6 acyl chains with a single phosphorylation site. GLA-AF contains GLA in an aqueous solution. One 2 mcg injection will be given per patient in the upper arm, each randomized to either subcutaneous or intramuscular routes. |
| GLA-SE | DRUG | GLA-SE contains GLA, a new synthetic lipid A molecule that combines 6 acyl chains with a single phosphorylation site. GLA-SE contains GLA in a squalene oil emulsion. One 2 mcg injection will be given per patient in the upper arm, each randomized to either subcutaneous or intramuscular routes. |
| Squalene | OTHER | Squalene is a natural organic compound obtained from shark liver oil. In this study, it is used to solubilize GLA in the GLA-SE formulation. Patients randomized to receive the squalene will be given one 2mcg injection of the squalene oil in the upper arm, each patient randomized further to either subcutaneous or intramuscular routes. |
Inclusion Criteria: 1. Healthy adult males and females, as assessed by a medical history, physical exam, and laboratory tests 2. Age of at least 18 years of age on the day of screening and no greater than 60 years at time of administration 3. Willing to comply with the requirements of the protocol ...