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Hyaluronidase · 1 trial · 1 indication
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, ...
Hyaluronidase is an investigational small molecule being studied for use in Allergic Skin Reaction. It is currently in Phase 2 clinical development. The drug is being evaluated for its potential to address allergic skin reactions, though it remains investigational and has not been approved for this indication.
Hyaluronidase does not target a specific molecular target or target class. It is a small molecule being studied for Allergic Skin Reaction, but its mechanism of action has not been specified in the available clinical development information.
Hyaluronidase is being developed by Amphastar Pharmaceuticals, Inc., a company traded on the stock exchange under the ticker symbol AMPH. The company is conducting clinical research on this drug for the treatment of Allergic Skin Reaction.
Hyaluronidase is in Phase 2 clinical development for Allergic Skin Reaction. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy.
Hyaluronidase has one completed clinical trial, NCT01689363, titled 'Evaluation of the Allergenicity of AMPHADASE INJECTION (Hyaluronidase Injection USP)'. This Phase 2 trial enrolled 253 participants in the United States and was a randomized, double-blind, placebo-controlled study involving healthy volunteers aged 18 years and older.
Hyaluronidase is the same as AMPHADASE, as indicated by the clinical trial title 'Evaluation of the Allergenicity of AMPHADASE INJECTION (Hyaluronidase Injection USP)'. The drug is also known by this brand name, which is used in the context of the clinical trial for Allergic Skin Reaction.