HealthyPhase 1NCT00435604
A Study of the Subcutaneous Injection of a Viscous Antibody Solution With Recombinant Human Hyaluronidase
A Phase 1 study testing Hylenex in people with Healthy, run by Halozyme Therapeutics.
Trial summary
This Phase I, randomized, double-blinded, within-subject controlled, two-way crossover study comparing the time to inject (flow rate), safety, and tolerability of a subcutaneously (SC) administered, viscous antibody solution of with and without human recombinant hyaluronidase (rHuPH20) in volunteer subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Hylenex
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Feb 2007to May 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteers of either sex, age 18 to 65 years, inclusive.
- Intact normal skin on both upper extremities without tattoos or potentially obscuring pigmentation or lesions.
- Vital signs (BP, HR, temperature, respiratory rate) within normal range.
- Metabolic panel (e.g., sodium, potassium, chloride, bicarbonate, BUN, creatinine, glucose, calcium, AST, ALT, alkaline phosphatase, total bilirubin, albumin, and total protein) within normal range within 7 days of injection.
- A negative serum or urine pregnancy test (if female of child-bearing potential) within 7 days of injection.
- Female subjects of child-bearing potential must be practicing effective birth control or abstinence currently and plan to continue to do so for the duration of the study.
- Decision-making capacity and willingness and ability to comply with the requirements for full completion of the trial.
- Willingness and ability to sign an informed consent document.
Who cannot join
- Upper extremity edema.
- Upper extremity pathology that could interfere with any protocol-specified outcome assessment (e.g., cellulitis, lymphatic disorder or prior surgery, preexisting pain syndrome, previous mastectomy and/or axillary lymph node dissection, etc.).
- Contraindication to an antibody, such as known history of anaphylactic or severe systemic reactions.
- Known predisposition to renal insufficiency or renal failure, including diabetes mellitus, volume depletion, sepsis, paraproteinemia, and subjects receiving known nephrotoxic drugs.
- Known allergy to hyaluronidase or any other ingredient in the formulation of Hylenex.
- Known allergy to bee or vespid venom.
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- Known coagulopathy.
- Pregnancy or breast-feeding woman.
- Known clinically significant cardiovascular, gastrointestinal, hepatic, neurological, psychiatric, endocrine, cancer, HIV infection, diabetes mellitus, intercurrent illness such as influenza, or other major systemic disease that would unduly risk the subject's safety or interfere with the interpretation of results.
- Participation in a study of any investigational drug or device within 30 days of enrollment in this study.
About this study
Official title: Phase I Dose-Ranging Randomized Double-Blinded Controlled Study of the Subcutaneous Injection of a Viscous Antibody Solution With Recombinant Human Hyaluronidase
This Phase I, randomized, double-blinded, within-subject controlled, two-way crossover study comparing the time to inject (flow rate), safety, and tolerability of a subcutaneously (SC) administered, viscous antibody solution of with and without human recombinant hyaluronidase (rHuPH20) in volunteer subjects.
The study hypothesizes that the time required to complete a 20-mL SC injection of a viscous antibody with rHuPH20 will be comparable or shorter than the time required for the injection without rHuPH20.
- Conditions
- Healthy
- Being tested
- Hylenex
- Keywords
- hyaluronidase, subcutaneous drug delivery, Volunteer Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HylenexDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The time to inject 20 mL of a viscous antibody solution with and without rHuPH20.
Secondary outcomes (1)
Assess the time required for a subcutaneous injection with various doses of rHuPH20, safety, tolerability.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2007 (estimated)
- Study startFeb 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Halozyme Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Anoshie Ratnayake, M.D., Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00435604
- Sponsor's protocol ID
- HZ2-07-01
- Status last verified
- Feb 2007
- First submitted
- 14 Feb 2007
- Last updated
- 17 Oct 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Dose-Ranging Randomized Double-Blinded Controlled Study of the Subcutaneous Injection of a Viscous Antibody Solution With Recombinant Human Hyaluronidase
- ClinicalTrials.gov ID
- NCT00435604
- Acronym / sponsor ID
- HZ2-07-01
- Conditions
- Healthy
- Keywords
- hyaluronidase, subcutaneous drug delivery, Volunteer Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Halozyme TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Study completion
- May 2007 (actual)
- First posted
- 15 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase I, randomized, double-blinded, within-subject controlled, two-way crossover study comparing the time to inject (flow rate), safety, and tolerability of a subcutaneously (SC) administered, viscous antibody solution of with and without human recombinant hyaluronidase (rHuPH20) in volunteer subjects.
The study hypothesizes that the time required to complete a 20-mL SC injection of a viscous antibody with rHuPH20 will be comparable or shorter than the time required for the injection without rHuPH20.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Volunteers of either sex, age 18 to 65 years, inclusive.
- Intact normal skin on both upper extremities without tattoos or potentially obscuring pigmentation or lesions.
- Vital signs (BP, HR, temperature, respiratory rate) within normal range.
- Metabolic panel (e.g., sodium, potassium, chloride, bicarbonate, BUN, creatinine, glucose, calcium, AST, ALT, alkaline phosphatase, total bilirubin, albumin, and total protein) within normal range within 7 days of injection.
- A negative serum or urine pregnancy test (if female of child-bearing potential) within 7 days of injection.
Key exclusion criteria (10 listed)
- Upper extremity edema.
- Upper extremity pathology that could interfere with any protocol-specified outcome assessment (e.g., cellulitis, lymphatic disorder or prior surgery, preexisting pain syndrome, previous mastectomy and/or axillary lymph node dissection, etc.).
- Contraindication to an antibody, such as known history of anaphylactic or severe systemic reactions.
- Known predisposition to renal insufficiency or renal failure, including diabetes mellitus, volume depletion, sepsis, paraproteinemia, and subjects receiving known nephrotoxic drugs.
- Known allergy to hyaluronidase or any other ingredient in the formulation of Hylenex.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hylenex | Drug | – |
Primary outcome
The time to inject 20 mL of a viscous antibody solution with and without rHuPH20.
1 secondary outcome
Assess the time required for a subcutaneous injection with various doses of rHuPH20, safety, tolerability.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anoshie Ratnayake, M.D. principal investigator
Principal Investigator
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hylenex in people with Healthy, run by Halozyme Therapeutics.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time to inject 20 mL of a viscous antibody solution with and without rHuPH20.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2011.