Trial Outcomes & Findings for Evaluation of the Allergenicity of AMPHADASE INJECTION (Hyaluronidase Injection USP) (NCT NCT01689363)

NCT ID: NCT01689363

Last Updated: 2017-01-20

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 253 participants
• Primary outcome timeframe: Up to 30 minutes after the final study drug injection
• Results posted on: 2017-01-20

Participant Flow

Participant milestones

Measure	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	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	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	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	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	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	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	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
Overall Study STARTED	32	32	32	31	31	31	32	32
Overall Study COMPLETED	32	31	32	31	31	31	32	32
Overall Study NOT COMPLETED	0	1	0	0	0	0	0	0

Reasons for withdrawal

Measure	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	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	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	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	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	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	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	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
Overall Study Protocol Violation	0	1	0	0	0	0	0	0

Baseline Characteristics

Evaluation of the Allergenicity of AMPHADASE INJECTION (Hyaluronidase Injection USP)

Baseline characteristics by cohort

Measure	Total Study Population n=253 Participants 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.
Age, Categorical <=18 years	7 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	239 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Age, Continuous	34.9 years STANDARD_DEVIATION 14.0 • n=5 Participants
Sex: Female, Male Female	127 Participants n=5 Participants
Sex: Female, Male Male	126 Participants n=5 Participants
Region of Enrollment United States	253 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 30 minutes after the final study drug injection

Population: 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

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.

Outcome measures

Measure	Per-Protocol Population (PPP) n=183 Participants 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	Arm N Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms	Arm P Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
Positive Allergic Reaction to Amphadase® in the Per-Protocol Population (PPP)	0 participants	—	—

PRIMARY outcome

Timeframe: Up to 30 minutes after the final study drug injection

Population: Subjects who have been randomized

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.

Outcome measures

Measure	Per-Protocol Population (PPP) n=253 Participants 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	Arm N Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms	Arm P Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
Positive Allergic Reaction to Amphadase® in the Intent-to-Treat Population (ITT)	7 participants	—	—

SECONDARY outcome

Timeframe: Up to 30 minutes after the final study drug injection

Population: 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

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.

Outcome measures

Measure	Per-Protocol Population (PPP) n=183 Participants 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	Arm N n=183 Participants Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms	Arm P n=183 Participants Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
Observed Wheal Size in the Per-Protocol Population (PPP)	1.1 mm Standard Deviation 2.6	1.7 mm Standard Deviation 2.7	15.3 mm Standard Deviation 4.9

SECONDARY outcome

Timeframe: Up to 30 minutes after the final study drug injection

Population: 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

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.

Outcome measures

Measure	Per-Protocol Population (PPP) n=183 Participants 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	Arm N n=183 Participants Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms	Arm P n=183 Participants Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
Observed Erythema Size in the Per-Protocol Population (PPP)	4.3 mm Standard Deviation 7.0	0.6 mm Standard Deviation 3.7	44.4 mm Standard Deviation 11.7

SECONDARY outcome

Timeframe: Up to 30 minutes after the final study drug injection

Population: 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

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.

Outcome measures

Measure	Per-Protocol Population (PPP) n=183 Participants 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	Arm N n=183 Participants Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms	Arm P n=183 Participants Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
Allergic Wheal Size in the Per-Protocol Population (PPP)	0.1 mm Standard Deviation 0.9	0.0 mm Standard Deviation 0.0	15.2 mm Standard Deviation 4.9

SECONDARY outcome

Timeframe: Up to 30 minutes after the final study drug injection

Population: 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

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.

Outcome measures

Measure	Per-Protocol Population (PPP) n=183 Participants 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	Arm N n=183 Participants Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms	Arm P n=183 Participants Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
Allergic Erythema Size in the Per-Protocol Population (PPP)	1.1 mm Standard Deviation 5.0	0.0 mm Standard Deviation 0.1	44.1 mm Standard Deviation 11.8

SECONDARY outcome

Timeframe: Up to 30 minutes after the final study drug injection

Population: 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

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.

Outcome measures

Measure	Per-Protocol Population (PPP) n=183 Participants 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	Arm N n=183 Participants Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms	Arm P n=183 Participants Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
Local Itchiness Rate in the Per-Protocol Population (PPP)	7.7 percentage of participants	1.1 percentage of participants	100.0 percentage of participants

SECONDARY outcome

Timeframe: Up to 30 minutes after the final study drug injection

Population: 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

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.

Outcome measures

Measure	Per-Protocol Population (PPP) n=183 Participants 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	Arm N n=183 Participants Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms	Arm P n=183 Participants Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
Erythema Responder Rate in the Per-Protocol Population (PPP)	51.4 percentage of participants	8.7 percentage of participants	100.0 percentage of participants

SECONDARY outcome

Timeframe: Up to 30 minutes after the final study drug injection

Population: Subjects who have been randomized

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.

Outcome measures

Measure	Per-Protocol Population (PPP) n=253 Participants 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	Arm N n=253 Participants Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms	Arm P n=253 Participants Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
Observed Wheal Size in the Intent-to-Treat Population (ITT)	1.5 mm Standard Deviation 3.3	1.7 mm Standard Deviation 2.8	14.1 mm Standard Deviation 5.6

SECONDARY outcome

Timeframe: Up to 30 minutes after the final study drug injection

Population: Subjects who have been randomized

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.

Outcome measures

Measure	Per-Protocol Population (PPP) n=253 Participants 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	Arm N n=253 Participants Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms	Arm P n=253 Participants Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
Observed Erythema Size in the Intent-to-Treat Population (ITT)	5.4 mm Standard Deviation 9.6	0.9 mm Standard Deviation 4.5	41.5 mm Standard Deviation 14.7

SECONDARY outcome

Timeframe: Up to 30 minutes after the final study drug injection

Population: Subjects who have been randomized

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.

Outcome measures

Measure	Per-Protocol Population (PPP) n=253 Participants 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	Arm N n=253 Participants Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms	Arm P n=253 Participants Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
Allergic Erythema Size in the Intent-to-Treat Population (ITT)	2.1 mm Standard Deviation 8.0	0.1 mm Standard Deviation 1.9	34.0 mm Standard Deviation 21.1

SECONDARY outcome

Timeframe: Up to 30 minutes after the final study drug injection

Population: Subjects who have been randomized

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.

Outcome measures

Measure	Per-Protocol Population (PPP) n=253 Participants 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	Arm N n=253 Participants Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms	Arm P n=253 Participants Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
Local Itchiness Rate in the Intent-to-Treat Population (ITT)	10.3 percentage of participants	1.6 percentage of participants	79.1 percentage of participants

SECONDARY outcome

Timeframe: Up to 30 minutes after the final study drug injection

Population: Subjects who have been randomized

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.

Outcome measures

Measure	Per-Protocol Population (PPP) n=253 Participants 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	Arm N n=253 Participants Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms	Arm P n=253 Participants Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
Erythema Responder Rate in the Intent-to-Treat Population (ITT)	53.8 percentage of participants	11.1 percentage of participants	97.6 percentage of participants

SECONDARY outcome

Timeframe: Up to 30 minutes after the final study drug injection

Population: Subjects who have been randomized

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.

Outcome measures

Measure	Per-Protocol Population (PPP) n=253 Participants 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	Arm N n=253 Participants Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms	Arm P n=253 Participants Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
Allergic Wheal Size in the Intent-to-Treat Population (ITT)	0.5 mm Standard Deviation 2.4	0.0 mm Standard Deviation 0.7	11.5 mm Standard Deviation 7.6

Adverse Events

Arm H

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm N

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm P

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

All Arms

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gisela Sharp

Amphastar Pharmaceuticals, Inc.

Phone: (909) 980-9484

Email: GiselaS@amphastar.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER