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This study is designed to evaluate the allergenicity of Amphadase® in healthy volunteers using an intradermal skin test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyaluronidase | Drug | Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two random sites on their forearms. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Positive Allergic Reaction to Amphadase® in the Per-Protocol Population (PPP) | 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. | Up to 30 minutes after the final study drug injection |
| Positive Allergic Reaction to Amphadase® in the Intent-to-Treat Population (ITT) | 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. | Up to 30 minutes after the final study drug injection |
| Measure | Description | Time Frame |
|---|---|---|
| Observed Wheal Size in the Per-Protocol Population (PPP) | 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. The observed wheal size is the greatest wheal diameter measured at the injection site(s) for a specific study drug injection. |
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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, assessed according to the judgment of the Principal Investigator. A non-inclusive list which would not be exclusionary and define healthy individual for the purposes of this study are:
hypothyroidism,
stable hypertension except those subjects on beta blockers including ocular preparations,
seasonal/perennial allergic rhinitis if able to wash out of antihistamines,
stable, mild intermittent asthma (subjects using beta agonists as a monotherapy on an as-needed basis, excluding daily usage),
migraine if not taking excluded medications,
mild anxiety/depression if not taking excluded medications, and
mild arthritic conditions if not taking excluded medications.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Selina Su, MPH | A:mphastar Pharmaceuticals, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amphastar Site 0022 | Eugene | Oregon | 97401 | United States | ||
| Amphastar Site 0023 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8672315 | Background | Barr J, Kirkpatrick N, Dick A, Leonard L, Hawksworth G, Noble DW. Effects of adrenaline and hyaluronidase on plasma concentrations of lignocaine and bupivacaine after peribulbar anaesthesia. Br J Anaesth. 1995 Dec;75(6):692-7. doi: 10.1093/bja/75.6.692. | |
| 8678264 | Background | Brydon CW, Basler M, Kerr WJ. An evaluation of two concentrations of hyaluronidase for supplementation of peribulbar anaesthesia. Anaesthesia. 1995 Nov;50(11):998-1000. doi: 10.1111/j.1365-2044.1995.tb05940.x. |
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| ID | Title | Description |
|---|---|---|
| FG000 | H, N, H, P | Subjects received four intradermal injections where study drug was injected to sites on the subject's forearms in the following order: 1) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the upper-left forearm; 2) 0.02 mL saline at the lower-left forearm; 3) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the upper-right forearm; 4) 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at the lower-right forearm |
| FG001 | H, N, P, H | Subjects received four intradermal injections where study drug was injected to sites on the subject's forearms in the following order: 1) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the upper-left forearm; 2) 0.02 mL saline at the lower-left forearm; 3) 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at the upper-right forearm; 4) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the lower-right forearm |
| FG002 | H, P, H, N | Subjects received four intradermal injections where study drug was injected to sites on the subject's forearms in the following order: 1) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the upper-left forearm; 2) 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at the lower-left forearm; 3) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the upper-right forearm; 4) 0.02 mL saline at the lower-right forearm |
| FG003 | H, P, N, H | Subjects received four intradermal injections where study drug was injected to sites on the subject's forearms in the following order: 1) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the upper-left forearm; 2) 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at the lower-left forearm; 3) 0.02 mL saline at the upper-right forearm; 4) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the lower-right forearm |
| FG004 | N, H, H, P | Subjects received four intradermal injections where study drug was injected to sites on the subject's forearms in the following order: 1) 0.02 mL saline at the upper-left forearm; 2) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the lower-left forearm; 3) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the upper-right forearm; 4) 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at the lower-right forearm |
| FG005 | N, H, P, H | Subjects received four intradermal injections where study drug was injected to sites on the subject's forearms in the following order: 1) 0.02 mL saline at the upper-left forearm; 2) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the lower-left forearm; 3) 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at the upper-right forearm; 4) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the lower-right forearm |
| FG006 | P, H, H, N | Subjects received four intradermal injections where study drug was injected to sites on the subject's forearms in the following order: 1) 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at the upper-left forearm; 2) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the lower-left forearm; 3) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the upper-right forearm; 4) 0.02 mL saline at the lower-right forearm |
| FG007 | P, H, N, H | Subjects received four intradermal injections where study drug was injected to sites on the subject's forearms in the following order: 1) 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at the upper-left forearm; 2) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the lower-left forearm; 3) 0.02 mL saline at the upper-right forearm; 4) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the lower-right forearm |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Total Study Population | Subjects received four intradermal injections of study drug (two injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL), one injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL), one injection of 0.02 mL saline) in a random order at four locations on the subjects' forearms. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Positive Allergic Reaction to Amphadase® in the Per-Protocol Population (PPP) | 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 who: a) have received the right treatment; b) have a negative reaction for the negative control; c) have a positive reaction for the positive control; and d) have the same reaction for both Amphadase® treatments | Posted | Number | participants | Up to 30 minutes after the final study drug injection |
|
Signing of Informed Consent until Adverse Event Resolution/Stabilization (approximately 30 days)
Adverse drug events (ADEs), whether observed by investigators or reported by the subjects, will be documented, evaluated, followed up, and treated if deemed necessary. ADEs will be followed until stabilized/resolved or 30 days from the date the subject has finished the study, whichever is sooner.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm H | Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gisela Sharp | Amphastar Pharmaceuticals, Inc. | (909) 980-9484 | 2016 | GiselaS@amphastar.com |
Not provided
| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D006821 | Hyaluronoglucosaminidase |
| D002810 | Chondroitinases and Chondroitin Lyases |
| D006632 | Histamine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D006026 | Glycoside Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
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| 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. |
|
| Up to 30 minutes after the final study drug injection |
| Observed Erythema Size in the Per-Protocol Population (PPP) | 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. The observed erythema size is the greatest erythema diameter measured at the injection site(s) for a specific study drug injection. | Up to 30 minutes after the final study drug injection |
| Allergic Wheal Size in the Per-Protocol Population (PPP) | 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. The allergic wheal size is the greatest wheal diameter with accompanying erythema and localized itching measured at the injection site(s) for a specific study drug injection. | Up to 30 minutes after the final study drug injection |
| Allergic Erythema Size in the Per-Protocol Population (PPP) | 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. The allergic erythema size is the greatest erythema diameter with accompanying localized itching measured at the injection site(s) for a specific study drug injection. | Up to 30 minutes after the final study drug injection |
| Local Itchiness Rate in the Per-Protocol Population (PPP) | 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. The local itchiness rate is the percentage of subjects that reported localized itching at the injection site(s) for a specific study drug injection. | Up to 30 minutes after the final study drug injection |
| Erythema Responder Rate in the Per-Protocol Population (PPP) | 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. The erythema responder rate is the percentage of subjects that showed an erythema reaction at the injection site(s) for a specific study drug injection. | Up to 30 minutes after the final study drug injection |
| Observed Wheal Size in the Intent-to-Treat Population (ITT) | 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. The observed wheal size is the greatest wheal diameter measured at the injection site(s) for a specific study drug injection. | Up to 30 minutes after the final study drug injection |
| Observed Erythema Size in the Intent-to-Treat Population (ITT) | 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. The observed erythema size is the greatest erythema diameter measured at the injection site(s) for a specific study drug injection. | Up to 30 minutes after the final study drug injection |
| Allergic Erythema Size in the Intent-to-Treat Population (ITT) | 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. The allergic erythema size is the greatest erythema diameter with accompanying localized itching measured at the injection site(s) for a specific study drug injection. | Up to 30 minutes after the final study drug injection |
| Local Itchiness Rate in the Intent-to-Treat Population (ITT) | 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. The local itchiness rate is the percentage of subjects that reported localized itching at the injection site(s) for a specific study drug injection. | Up to 30 minutes after the final study drug injection |
| Erythema Responder Rate in the Intent-to-Treat Population (ITT) | 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. The erythema responder rate is the percentage of subjects that showed an erythema reaction at the injection site(s) for a specific study drug injection. | Up to 30 minutes after the final study drug injection |
| Allergic Wheal Size in the Intent-to-Treat Population (ITT) | 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. The allergic wheal size is the greatest wheal diameter with accompanying erythema and localized itching measured at the injection site(s) for a specific study drug injection. | Up to 30 minutes after the final study drug injection |
| Lake Oswego |
| Oregon |
| 97035 |
| United States |
| Amphastar Site 0026 | Portland | Oregon | 97202 | United States |
| Amphastar Site 0038 | Renton | Washington | 98057 | United States |
| Amphastar Site 0034 | Seattle | Washington | 98115 | United States |
| 12640426 | Background | Ahluwalia HS, Lukaris A, Lane CM. Delayed allergic reaction to hyaluronidase: a rare sequel to cataract surgery. Eye (Lond). 2003 Mar;17(2):263-6. doi: 10.1038/sj.eye.6700243. No abstract available. |
| 12694021 | Background | Agrawal A, McLure HA, Dabbs TR. Allergic reaction to hyaluronidase after a peribulbar injection. Anaesthesia. 2003 May;58(5):493-4. doi: 10.1046/j.1365-2044.2003.03154_17.x. No abstract available. |
| 1302146 | Background | Kempeneers A, Dralands L, Ceuppens J. Hyaluronidase induced orbital pseudotumor as complication of retrobulbar anesthesia. Bull Soc Belge Ophtalmol. 1992;243:159-66. |
| 8185511 | Background | Minning CA Jr. Hyaluronidase allergy simulating expulsive choroidal hemorrhage. Arch Ophthalmol. 1994 May;112(5):585-6. doi: 10.1001/archopht.1994.01090170029012. No abstract available. |
| 9083759 | Background | Szepfalusi Z, Nentwich I, Dobner M, Pillwein K, Urbanek R. IgE-mediated allergic reaction to hyaluronidase in paediatric oncological patients. Eur J Pediatr. 1997 Mar;156(3):199-203. doi: 10.1007/s004310050582. |
| 2578014 | Background | Allergy testing. American College of Physicians. Ann Intern Med. 1989 Feb 15;110(4):317-20. No abstract available. |
| 11419727 | Background | Poulsen LK. In vivo and in vitro techniques to determine the biological activity of food allergens. J Chromatogr B Biomed Sci Appl. 2001 May 25;756(1-2):41-55. doi: 10.1016/s0378-4347(01)00070-6. |
| 9207725 | Background | Howard A, Mercer P, Nataraj HC, Kang BC. Bevel-down superior to bevel-up in intradermal skin testing. Ann Allergy Asthma Immunol. 1997 Jun;78(6):594-6. doi: 10.1016/s1081-1206(10)63222-x. |
| 9764148 | Background | Barbaud A, Reichert-Penetrat S, Trechot P, Jacquin-Petit MA, Ehlinger A, Noirez V, Faure GC, Schmutz JL, Bene MC. The use of skin testing in the investigation of cutaneous adverse drug reactions. Br J Dermatol. 1998 Jul;139(1):49-58. doi: 10.1046/j.1365-2133.1998.02313.x. |
| 9301390 | Background | Fisher MM, Bowey CJ. Intradermal compared with prick testing in the diagnosis of anaesthetic allergy. Br J Anaesth. 1997 Jul;79(1):59-63. doi: 10.1093/bja/79.1.59. |
| 3597862 | Background | Ruzicka T, Gerstmeier M, Przybilla B, Ring J. Allergy to local anesthetics: comparison of patch test with prick and intradermal test results. J Am Acad Dermatol. 1987 Jun;16(6):1202-8. doi: 10.1016/s0190-9622(87)70158-3. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Positive Allergic Reaction to Amphadase® in the Intent-to-Treat Population (ITT) | 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 who have been randomized | Posted | Number | participants | Up to 30 minutes after the final study drug injection |
|
|
|
| Secondary | Observed Wheal Size in the Per-Protocol Population (PPP) | 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. The observed wheal size is the greatest wheal diameter measured at the injection site(s) for a specific study drug injection. | Subjects who: a) have received the right treatment; b) have a negative reaction for the negative control; c) have a positive reaction for the positive control; and d) have the same reaction for both Amphadase® treatments | Posted | Mean | Standard Deviation | mm | Up to 30 minutes after the final study drug injection |
|
|
|
| Secondary | Observed Erythema Size in the Per-Protocol Population (PPP) | 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. The observed erythema size is the greatest erythema diameter measured at the injection site(s) for a specific study drug injection. | Subjects who: a) have received the right treatment; b) have a negative reaction for the negative control; c) have a positive reaction for the positive control; and d) have the same reaction for both Amphadase® treatments | Posted | Mean | Standard Deviation | mm | Up to 30 minutes after the final study drug injection |
|
|
|
| Secondary | Allergic Wheal Size in the Per-Protocol Population (PPP) | 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. The allergic wheal size is the greatest wheal diameter with accompanying erythema and localized itching measured at the injection site(s) for a specific study drug injection. | Subjects who: a) have received the right treatment; b) have a negative reaction for the negative control; c) have a positive reaction for the positive control; and d) have the same reaction for both Amphadase® treatments | Posted | Mean | Standard Deviation | mm | Up to 30 minutes after the final study drug injection |
|
|
|
| Secondary | Allergic Erythema Size in the Per-Protocol Population (PPP) | 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. The allergic erythema size is the greatest erythema diameter with accompanying localized itching measured at the injection site(s) for a specific study drug injection. | Subjects who: a) have received the right treatment; b) have a negative reaction for the negative control; c) have a positive reaction for the positive control; and d) have the same reaction for both Amphadase® treatments | Posted | Mean | Standard Deviation | mm | Up to 30 minutes after the final study drug injection |
|
|
|
| Secondary | Local Itchiness Rate in the Per-Protocol Population (PPP) | 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. The local itchiness rate is the percentage of subjects that reported localized itching at the injection site(s) for a specific study drug injection. | Subjects who: a) have received the right treatment; b) have a negative reaction for the negative control; c) have a positive reaction for the positive control; and d) have the same reaction for both Amphadase® treatments | Posted | Number | percentage of participants | Up to 30 minutes after the final study drug injection |
|
|
|
| Secondary | Erythema Responder Rate in the Per-Protocol Population (PPP) | 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. The erythema responder rate is the percentage of subjects that showed an erythema reaction at the injection site(s) for a specific study drug injection. | Subjects who: a) have received the right treatment; b) have a negative reaction for the negative control; c) have a positive reaction for the positive control; and d) have the same reaction for both Amphadase® treatments | Posted | Number | percentage of participants | Up to 30 minutes after the final study drug injection |
|
|
|
| Secondary | Observed Wheal Size in the Intent-to-Treat Population (ITT) | 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. The observed wheal size is the greatest wheal diameter measured at the injection site(s) for a specific study drug injection. | Subjects who have been randomized | Posted | Mean | Standard Deviation | mm | Up to 30 minutes after the final study drug injection |
|
|
|
| Secondary | Observed Erythema Size in the Intent-to-Treat Population (ITT) | 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. The observed erythema size is the greatest erythema diameter measured at the injection site(s) for a specific study drug injection. | Subjects who have been randomized | Posted | Mean | Standard Deviation | mm | Up to 30 minutes after the final study drug injection |
|
|
|
| Secondary | Allergic Erythema Size in the Intent-to-Treat Population (ITT) | 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. The allergic erythema size is the greatest erythema diameter with accompanying localized itching measured at the injection site(s) for a specific study drug injection. | Subjects who have been randomized | Posted | Mean | Standard Deviation | mm | Up to 30 minutes after the final study drug injection |
|
|
|
| Secondary | Local Itchiness Rate in the Intent-to-Treat Population (ITT) | 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. The local itchiness rate is the percentage of subjects that reported localized itching at the injection site(s) for a specific study drug injection. | Subjects who have been randomized | Posted | Number | percentage of participants | Up to 30 minutes after the final study drug injection |
|
|
|
| Secondary | Erythema Responder Rate in the Intent-to-Treat Population (ITT) | 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. The erythema responder rate is the percentage of subjects that showed an erythema reaction at the injection site(s) for a specific study drug injection. | Subjects who have been randomized | Posted | Number | percentage of participants | Up to 30 minutes after the final study drug injection |
|
|
|
| Secondary | Allergic Wheal Size in the Intent-to-Treat Population (ITT) | 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. The allergic wheal size is the greatest wheal diameter with accompanying erythema and localized itching measured at the injection site(s) for a specific study drug injection. | Subjects who have been randomized | Posted | Mean | Standard Deviation | mm | Up to 30 minutes after the final study drug injection |
|
|
|
| 0 |
| 253 |
| 0 |
| 253 |
| EG001 | Arm N | Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms | 0 | 253 | 0 | 253 |
| EG002 | Arm P | Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms | 0 | 253 | 0 | 253 |
| EG003 | All Arms | Cannot identify which study drug may be associated with the ADE because the subject received all four injections almost at the same time | 0 | 253 | 0 | 253 |
Not provided
| D011133 |
| Polysaccharide-Lyases |
| D019757 | Carbon-Oxygen Lyases |
| D008190 | Lyases |
| D013429 | Sulfatases |
| D004950 | Esterases |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005021 | Ethylamines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |