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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01689363 | Evaluation of the Allergenicity of AMPHADASE INJECTION (Hyaluronidase Injection USP) | PHASE2 | COMPLETED | 253 | — | — | Sep 1, 2012 | Dec 1, 2012 | Jan 20, 2017 | 5 | United States |
Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. A positive reaction consisted of: a) reaction appearing within 30 minutes of drug placement; b) wheal (\>8 mm) with or without pseudopods; c) reaction accompanying erythema; and d) reaction accompanying localized itching.
Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. A positive reaction consisted of: a) reaction appearing within 30 minutes of drug placement; b) wheal (\>8 mm) with or without pseudopods; c) reaction accompanying erythema; and d) reaction accompanying localized itching.
| Arm | Type | Description |
|---|---|---|
| Arm H | EXPERIMENTAL | Intradermal injection of Amphadase (hyaluronidase 150 USP units/mL) |
| Arm P | ACTIVE_COMPARATOR | Intradermal injection of Histatrol (histamine base 0.1 mg/mL) |
| Arm N | PLACEBO_COMPARATOR | Intradermal injection of saline (0.02 mL) |
| Name | Type | Description |
|---|---|---|
| Hyaluronidase | DRUG | Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two random sites on their forearms. |
| Histamine | DRUG | Subjects received one intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one random sites on their forearms. |
| Saline | DRUG | Subjects received one intradermal injection of 0.02 mL saline at one random site on their forearm. |
Inclusion Criteria: Healthy volunteers of either gender; Those without clinically significant cardiovascular gastrointestinal, hepatic, neurological, psychiatric, endocrine, or other major systemic disease that would unduly risk the subject's safety or interfere with the interpretation of results, ...