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rHuPH20 · 3 trials · 3 indications
Cutaneous reactions at the patch test sites were scored according to the ICDRG scoring scale as Grade 0 (-)= Negative reaction, Grade 1/2 (?)= Doubtful reaction; faint macular erythema only, Grade 1 (1+)= Weak (nonvesicular) positive reaction; erythema, infiltration, papules, vesicles, Grade 2 (2+): Strong (vesicular) positive reaction; erythema, infiltration, papules, vesicles, Grade 3 (3+): Extreme positive reaction; bullous reaction Grade NA (IR): Irritant reaction of different types. Participants with positive reaction scores (\>= Grade 1) have been reported in this outcome measure.
Cutaneous reactions at the patch test sites were scored according to the ICDRG scoring scale as Grade 0 (-)= Negative reaction, Grade 1/2 (?)= Doubtful reaction; faint macular erythema only, Grade 1 (1+)= Weak (nonvesicular) positive reaction; erythema, infiltration, papules, vesicles, Grade 2 (2+): Strong (vesicular) positive reaction; erythema, infiltration, papules, vesicles, Grade 3 (3+): Extreme positive reaction; bullous reaction Grade NA (IR): Irritant reaction of different types. Participants with positive reaction scores (\>= Grade 1) have been reported in this outcome measure.
| Arm | Type | Description |
|---|---|---|
| rHuPH20 | EXPERIMENTAL | Participant's upper back will be divided into 2 equal spaces and will receive Regimen 1 and 2 in 4 spaces respectively. In Regimen 1, a single row of 4 patches, each with the nickel sulfate concentration (NSC) (1, 2.5, or 5%) determined at screening, will be applied to the upper space at Day 1. After 48 hours, the patches will be removed and the reactions will be graded on the ICDRG scale. An ID injection containing rHuPH20 (3,000 Units \[U\]) will be administered once daily (QD) for 5 days at the center of each area of reaction. In Regimen 2, a single row of 4 sites in the lower space will be injected intradermally with drug rHuPH20 (3,000 U) at Day 1. Ten minutes after the injections, patches with the NSC (1, 2.5, or 5%) determined at screening will be applied to the injection sites. After 48 hours, the patches will be removed and the reactions will be graded on the ICDRG scale. As during pretreatment, an ID injection containing rHuPH20 will be then administered QD for 5 days. |
| Placebo | PLACEBO_COMPARATOR | Participant's upper back will be divided into 2 equal spaces and will receive Regimen 1 and 2 in 4 spaces respectively. In Regimen 1, a single row of 4 patches, each with the NSC (1, 2.5, or 5%) determined at screening, will be applied to the upper space at Day 1. After 48 hours, the patches will be removed and the reactions will be graded on the ICDRG scale. An ID injection containing placebo will be administered QD for 5 days at the center of each area of reaction. In Regimen 2, a single row of 4 sites in the lower space will be injected intradermally with placebo at Day 1. Ten minutes after the injections, patches with the NSC (1, 2.5, or 5%) determined at screening will be applied to the injection sites. After 48 hours, the patches will be removed and the reactions will be graded on the ICDRG scale. As during pretreatment, an ID injection containing placebo will be then administered QD for 5 days. |
| Stage 1: rHuPH20 plus ZA | EXPERIMENTAL | Participants will receive one of several dose/concentrations of recombinant human hyaluronidase PH20 (rHuPH20) with zoledronic acid (ZA). |
| Stage 2: ZA | EXPERIMENTAL | Participants will receive a dose/concentration of ZA administered without rHuPH20. |
| Stage 3: rHuPH20 plus ZA | EXPERIMENTAL | Participants will receive one of several dose/concentrations of rHuPH20 with ZA. |
| Stage 4: ZA | EXPERIMENTAL | Participants will receive an intravenous (IV) dose of 5 milligrams (mg) ZA. |
| Stage 4: ZA with rHuPH20 | EXPERIMENTAL | Participants will receive a subcutaneous (SC) dose of ZA with rHuPH20. |
| Stage 1: 3 U insulin plus rHuPH20 | EXPERIMENTAL | Participants will receive 3 Units (U) of regular insulin (100 U/milliliter \[mL\]), coadministered with sequential concentrations of 0, 1.25, 5, 10, 20, and 80 micrograms (μg)/mL recombinant human hyaluronidase (rHuPH20). |
| Stage 1: 12 U insulin plus rHuPH20 | EXPERIMENTAL | Participants will receive 12 U of regular insulin (100 U/mL), coadministered with sequential concentrations of 0, 1.25, 5, 10, 20, and 80 μg/mL rHuPH20. |
| Stage 2: insulin plus rHuPH20 | EXPERIMENTAL | Participants will receive 6, 12, and 24 U regular insulin (100 U/mL) in a randomly assigned order, with each insulin dose administered once with and once without 5 μg/mL rHuPH20. |
| Stage 3: 1.5 U insulin lispro plus rHuPH20 | EXPERIMENTAL | Participants will receive 1.5 U of insulin lispro (50 U/mL), coadministered with sequential concentrations of 0, 0.0625, 0.3125, 1.25, 5, and 20 μg/mL rHuPH20. |
| Stage 3: 6 U insulin lispro plus rHuPH20 | EXPERIMENTAL | Participants will receive 6 U of insulin lispro (50 U/mL), coadministered with sequential concentrations of 0, 0.0625, 0.3125, 1.25, 5, and 20 μg/mL rHuPH20. |
| Stage 4: 95 U/mL insulin lispro plus 5 μg/mL rHuPH20 | EXPERIMENTAL | Participants will receive 95 U/mL insulin lispro, administered once with and once without 5 μg/mL rHuPH20. At each insulin lispro concentration, participants will receive 2, 6, and 20 U lispro. |
| Stage 4: 50 U/mL insulin lispro plus 5 μg/mL rHuPH20 | EXPERIMENTAL | Participants will receive 50 U/mL insulin lispro, administered once with and once without 5 μg/mL rHuPH20. At each insulin lispro concentration, participants will receive 2, 6, and 20 U lispro. |
| Stage 4: 25 U/mL insulin lispro plus 5 μg/mL rHuPH20 | EXPERIMENTAL | Participants will receive 25 U/mL insulin lispro, administered once with and once without 5 μg/mL rHuPH20. At each insulin lispro concentration, participants will receive 2, 6, and 20 U lispro. |
| Name | Type | Description |
|---|---|---|
| rHuPH20 | DRUG | 0.25 milliliter (mL) Intradermal (ID) syringe push bolus injection of rHuPH20 |
| Placebo | DRUG | 0.25 mL ID syringe push bolus injection of placebo control |
| zoledronic acid | DRUG | subcutaneous injection |
| Insulin Human Injection | DRUG | injection |
| Insulin Lispro Injection | DRUG | injection |
Inclusion Criteria: * Females 18-60 years of age. Females of child-bearing potential must use a standard and effective means of birth control for the duration of the study. * Known contact dermatitis to nickel with a confirmed positive patch-test result to nickel sulfate. * Intact normal skin witho...
rHuPH20 is an investigational recombinant human hyaluronidase being studied for use in healthy volunteers, dermatitis and allergic contact dermatitis, and in people with risk factors for or a diagnosis of osteoporosis. It is in clinical development and has not been approved by the FDA.
rHuPH20 is being developed by Halozyme Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker HALO. The company is conducting clinical trials of rHuPH20 in the United States across multiple indications.
rHuPH20 is in Phase 2 clinical development. It has completed Phase 1 and Phase 2 trials, including a Phase 2 study in participants with nickel allergic contact dermatitis. The drug remains investigational and is not FDA approved.
rHuPH20 has been studied in three completed clinical trials: NCT00803972, a Phase 1 dose-ranging study in healthy volunteers; NCT00807963, a Phase 1 study of subcutaneous bisphosphonate with rHuPH20 in osteoporosis; and NCT00928447, a Phase 2 study in nickel allergic contact dermatitis.
rHuPH20 is a recombinant human hyaluronidase enzyme. The data provided does not list alternative names for rHuPH20, so it is not confirmed to be the same as Hylenex or any other branded product.