Allergic ReactionsPhase 1NCT01204866
Study of Valortim® (MDX-1303) and Its Selected Formulation Components Percutaneous Use
A Phase 1 study testing Valortim and selected Components in people with Allergic Reactions, run by PharmAthene, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine if Valortim, or one or more of its selected formulation components, induces a wheal reaction when introduced percutaneously. Two of 4 subjects dosed in a previous study with a modified formulation of Valortim experienced treatment related adverse events which were suggestive… Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Reactions
- What is being tested?
- Valortim and selected Components
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Sep 2010
- 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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- In the opinion of the Investigator, subjects should be in generally good health, based upon pre-study medical history and abbreviated physical exam.
- Female subjects cannot be pregnant, as confirmed by a negative urine pregnancy test at Study Day 1, prior to skin testing.
- Women of childbearing potential may be enrolled if one of the following criteria applies:
- Must be using an effective form of contraception for at least one month prior to study entry, must have a negative urine pregnancy test on Day 1, prior to skin testing
- Is sexually abstinent
- Is monogamous with a vasectomized partner (>3 months prior)
Show all 14Show fewer
- Is postmenopausal (i.e. no cycle for at least the previous 12 months, is of menopausal age (>45 years) and has a negative urine pregnancy test on Day 1, prior to skin testing
- Is surgically sterilized
- Has had a total hysterectomy
- Sexually active male subjects may be enrolled if one of the following criteria applies:
- Has had a vasectomy
- Using condoms and whose partner is using an acceptable form of contraception *Is sexually abstinent.
- In addition to the Inclusion Criteria above, Stage II Subjects must also meet the following criteria :
- Must have participated in PharmAthene Study #0036-08-05 and have been previously exposed in that study to Valortim.
Who cannot join
- Antihistamine use within 14 days of testing. Medications with antihistamine properties (i.e., anticholinergic agents, phenothiazine), beta-blockers, MAO-inhibitors or tricyclic antidepressant use within 1 day of testing.
- Dermatographia, or extreme skin sensitivity.
- History of allergic rhinitis, asthma or eczema.
- Outward signs of active allergies or upper respiratory infection.
- Known pregnancy as confirmed by urine pregnancy testing on Day 1, prior to skin testing procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kansas City Allergy and Asthma
Overland Park, Kansas, 66210
About this study
Official title: A Phase I, Open Label, Controlled Study of Valortim® (MDX-1303) and Its Selected Formulation Components When Introduced Percutaneously in Subjects Who Have and Have Not Been Exposed to Valortim Administered Intravenously
The purpose of this study is to determine if Valortim, or one or more of its selected formulation components, induces a wheal reaction when introduced percutaneously.
Two of 4 subjects dosed in a previous study with a modified formulation of Valortim experienced treatment related adverse events which were suggestive of allergic or allergic-like reactions. In order to better characterize these reactions and determine if they represent allergic or allergic-like reactions to Valortim or one or more of its components, skin testing of Valortim and selected components on naïve and Valortim-exposed subjects will be performed in this study
Read the detailed description
A maximum of 7 subjects will participate in the study. Up to four of these subjects have been previously exposed to IV Valortim.
The study will be conducted in two stages. The first stage will be performed on subjects not previously exposed to Valortim (Valortim-naïve subjects), to determine the correct dilutions of the test components. The second stage will be performed on the Valortim-exposed subjects using the dilutions of test components as determined in the first stage of the study.
The following components will be tested to determine their ability to induce a wheal reaction shortly after exposure to the skin by percutaneous application by needle prick: Valortim (Lot# 10-08-001), polysorbate 80, mannitol, histamine (positive control), and saline (negative control). All components except histamine will be provided to the clinical site by PharmAthene with detailed instructions for handling, storage, and dilution. A tiny drop of the aforementioned components will be introduced onto the surface of the skin and the skin will be pricked, allowing the components to enter the surface of the skin. Multiple components will be tested on the subjects' forearms or back; location of testing to be determined by scars, moles,pre-existing skin lesions, or other issues deemed by the Principal Investigator (PI) to have the potential to interfere with interpretation of the results.
Stage I:
- 3 Valortim-naïve, non-allergic subjects
- Only one subject will be skin tested in a single day
- Subjects will be tested percutaneously with the above mentioned components at the following dilutions:
- Valortim (Lot #10-08-001, 25 mg/mL) will be filtered through a 0.22 µm syringe filter and diluted 1:1000, 1:100, 1:10, and 1:1 in saline.
- Polysorbate 80 will be diluted in saline to the following concentrations: 0.06 mg/mL, 0.2 mg/mL, and 0.6 mg/mL.
- Mannitol (30 mg/mL) will be diluted in saline to the following concentrations: 1:1000, 1:100, 1:10, and 1:1
- Histamine (1 mg/mL), positive control
- Saline (0.9%), negative control.
- Multiple dilutions of Valortim, polysorbate 80, and mannitol will be used to determine the appropriate dilution for the second stage of the study in an attempt to avoid the possibility of a false positive reaction due to irritation.
- The starting dilution for Valortim and mannitol will be 1:1000 and will move progressively to more concentrated dilutions (1:100, 1:10, 1:1). The starting dilution for polysorbate 80 will be 0.06 mg/mL and will also move progressively higher to concentrations of 0.2 mg/mL and 0.6 mg/mL respectively.
- Fifteen minutes after the application of the test articles, the skin test sites will be examined for a wheal reaction. The skin sites will be examined again 1 hour following testing, just prior to discharge from the clinic. Subjects will return at 1 and 2 days following testing to assess the skin testing sites and to observe for any adverse events.
- A skin test is considered positive if, at 15 minutes following application, the wheal produced by the test article is equal to or greater than, that caused by positive control (histamine), or is at least 3 mm greater than the wheal of negative control (saline).
- A negative skin test is no wheal, or a wheal less than 3 mm larger than the saline control as determined at 15 minutes following application.
Stage II:
- It is anticipated that up to 4 subjects that received Valortim in a previous study (#0036-08-05) will participate in Stage II of the study; two of these subjects experienced adverse events while being dosed with Valortim. Subjects will each be tested percutaneously with Valortim, polysorbate 80, mannitol, histamine, and saline.
- Only one subject will be skin tested in a single day.
- The appropriate dilution for Valortim, mannitol, and polysorbate 80 will be based on the results from Stage I of this study. As was done in Stage I, Valortim will be filtered through a 0.22 µm syringe filter. Histamine (1 mg/mL) and saline (0.9%) will be used as the positive and negative controls, respectively.
- Fifteen minutes after the application of the test articles and pricking the skin, the skin test sites will be examined for a wheal reaction. The skin sites will be examined again 1 hour following testing, just prior to discharge from the clinic. Subjects will return at 1 and 2 days following testing to assess the skin testing site and to observe for any adverse events.
- A skin test is considered positive if the wheal produced by the test article 15 minutes following application is equal to or greater than that caused by positive control (histamine), or is at least 3 mm greater than the wheal of negative control (saline).
- A negative skin test is no wheal, or a wheal less than 3 mm larger than the saline control as determined at 15 minutes following application.
- Conditions
- Allergic Reactions
- Being tested
- Valortim and selected Components
- Keywords
- Allergic-Like Reaction, Selected Formulation Components
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valortim and selected ComponentsBiological
Also called Anthrax
- Valortim (Lot #10-08-001, 25 mg/mL) will be filtered through a 0.22 µm syringe filter and diluted 1:1000, 1:100, 1:10, and 1:1 in saline.
- Polysorbate 80 will be diluted in saline to the following concentrations: 0.06 mg/mL, 0.2 mg/mL, and 0.6 mg/mL.
- Mannitol (30 mg/mL) will be diluted in saline to the following concentrations: 1:1000, 1:100, 1:10, and 1:1
- Histamine (1 mg/mL), positive control
- Saline (0.9%), negative control
Valortim and Selected ComponentsDrug
Also called Anthrax
- It is anticipated that up to 4 subjects that received Valortim in a previous study (#0036-08-05) will participate in Stage II of the study; two of these subjects experienced adverse events while being dosed with Valortim. Subjects will each be tested percutaneously with Valortim, polysorbate 80, mannitol, histamine, and saline.
- Only one subject will be skin tested in a single day.
- The appropriate dilution for Valortim, mannitol, and polysorbate 80 will be based on the results from Stage I of this study. As was done in Stage I, Valortim will be filtered through a 0.22 µm syringe filter. Histamine (1 mg/mL) and saline (0.9%) will be used as the positive and negative controls, respectively
| Study group | Role | What they receive |
|---|---|---|
| Stage I | Experimental | Three (3) healthy male or female volunteers aged 18-59 years, not previously exposed to Valortim and who do not have pre-existing allergies Receives: Biological: Valortim and selected Components |
| Stage II | Experimental | Up to 4 healthy male or female volunteers aged 18-59 previously exposed to intravenous (IV) Valortim in PharmAthene Study #0036-08-05 Receives: Drug: Valortim and Selected Components |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Testing Results
Assessment of any wheal reaction from the study drug or its selected components and how this compares to the positive and negative control
Measured: Initial results assessed after 15minutes and up to 72 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2010 (estimated)
- Study startJul 2010
- Primary completionAug 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic ReactionsStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmAthene, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH)
- Investigators
- Jeffrey Wald, MD, Principal investigator, Kansas City Allergy and AsthmaValerie Riddle, MD, Study director, Sponsor Medical Monitor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01204866
- Sponsor's protocol ID
- 0036-08-05-A
- Other IDs
- HHSN272200700033C, 09-0117
- Status last verified
- Sep 2010
- First submitted
- 16 Sep 2010
- Last updated
- 24 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label, Controlled Study of Valortim® (MDX-1303) and Its Selected Formulation Components When Introduced Percutaneously in Subjects Who Have and Have Not Been Exposed to Valortim Administered Intravenously
- ClinicalTrials.gov ID
- NCT01204866
- Acronym / sponsor ID
- 0036-08-05-A
- Conditions
- Allergic Reactions
- Keywords
- Allergic-Like Reaction, Selected Formulation Components
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- PharmAthene, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH)
- Study start
- Jul 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 17 Sep 2010 (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.
The purpose of this study is to determine if Valortim, or one or more of its selected formulation components, induces a wheal reaction when introduced percutaneously.
Two of 4 subjects dosed in a previous study with a modified formulation of Valortim experienced treatment related adverse events which were suggestive of allergic or allergic-like reactions. In order to better characterize these reactions and determine if they represent allergic or allergic-like reactions to Valortim or one or more of its components, skin testing of Valortim and selected components on naïve and Valortim-exposed subjects will be performed in this study
Detailed description
A maximum of 7 subjects will participate in the study. Up to four of these subjects have been previously exposed to IV Valortim.
The study will be conducted in two stages. The first stage will be performed on subjects not previously exposed to Valortim (Valortim-naïve subjects), to determine the correct dilutions of the test components. The second stage will be performed on the Valortim-exposed subjects using the dilutions of test components as determined in the first stage of the study.
The following components will be tested to determine their ability to induce a wheal reaction shortly after exposure to the skin by percutaneous application by needle prick: Valortim (Lot# 10-08-001), polysorbate 80, mannitol, histamine (positive control), and saline (negative control). All components except histamine will be provided to the clinical site by PharmAthene with detailed instructions for handling, storage, and dilution. A tiny drop of the aforementioned components will be introduced onto the surface of the skin and the skin will be pricked, allowing the components to enter the surface of the skin. Multiple components will be tested on the subjects' forearms or back; location of testing to be determined by scars, moles,pre-existing skin lesions, or other issues deemed by the Principal Investigator (PI) to have the potential to interfere with interpretation of the results.
Stage I:
- 3 Valortim-naïve, non-allergic subjects
- Only one subject will be skin tested in a single day
- Subjects will be tested percutaneously with the above mentioned components at the following dilutions:
- Valortim (Lot #10-08-001, 25 mg/mL) will be filtered through a 0.22 µm syringe filter and diluted 1:1000, 1:100, 1:10, and 1:1 in saline.
- Polysorbate 80 will be diluted in saline to the following concentrations: 0.06 mg/mL, 0.2 mg/mL, and 0.6 mg/mL.
- Mannitol (30 mg/mL) will be diluted in saline to the following concentrations: 1:1000, 1:100, 1:10, and 1:1
- Histamine (1 mg/mL), positive control
- Saline (0.9%), negative control.
- Multiple dilutions of Valortim, polysorbate 80, and mannitol will be used to determine the appropriate dilution for the second stage of the study in an attempt to avoid the possibility of a false positive reaction due to irritation.
- The starting dilution for Valortim and mannitol will be 1:1000 and will move progressively to more concentrated dilutions (1:100, 1:10, 1:1). The starting dilution for polysorbate 80 will be 0.06 mg/mL and will also move progressively higher to concentrations of 0.2 mg/mL and 0.6 mg/mL respectively.
- Fifteen minutes after the application of the test articles, the skin test sites will be examined for a wheal reaction. The skin sites will be examined again 1 hour following testing, just prior to discharge from the clinic. Subjects will return at 1 and 2 days following testing to assess the skin testing sites and to observe for any adverse events.
- A skin test is considered positive if, at 15 minutes following application, the wheal produced by the test article is equal to or greater than, that caused by positive control (histamine), or is at least 3 mm greater than the wheal of negative control (saline).
- A negative skin test is no wheal, or a wheal less than 3 mm larger than the saline control as determined at 15 minutes following application.
Stage II:
- It is anticipated that up to 4 subjects that received Valortim in a previous study (#0036-08-05) will participate in Stage II of the study; two of these subjects experienced adverse events while being dosed with Valortim. Subjects will each be tested percutaneously with Valortim, polysorbate 80, mannitol, histamine, and saline.
- Only one subject will be skin tested in a single day.
- The appropriate dilution for Valortim, mannitol, and polysorbate 80 will be based on the results from Stage I of this study. As was done in Stage I, Valortim will be filtered through a 0.22 µm syringe filter. Histamine (1 mg/mL) and saline (0.9%) will be used as the positive and negative controls, respectively.
- Fifteen minutes after the application of the test articles and pricking the skin, the skin test sites will be examined for a wheal reaction. The skin sites will be examined again 1 hour following testing, just prior to discharge from the clinic. Subjects will return at 1 and 2 days following testing to assess the skin testing site and to observe for any adverse events.
- A skin test is considered positive if the wheal produced by the test article 15 minutes following application is equal to or greater than that caused by positive control (histamine), or is at least 3 mm greater than the wheal of negative control (saline).
- A negative skin test is no wheal, or a wheal less than 3 mm larger than the saline control as determined at 15 minutes following application.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stage I | Experimental | Biological: Valortim and selected ComponentsThree (3) healthy male or female volunteers aged 18-59 years, not previously exposed to Valortim and who do not have pre-existing allergies |
| Stage II | Experimental | Drug: Valortim and Selected ComponentsUp to 4 healthy male or female volunteers aged 18-59 previously exposed to intravenous (IV) Valortim in PharmAthene Study #0036-08-05 |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- In the opinion of the Investigator, subjects should be in generally good health, based upon pre-study medical history and abbreviated physical exam.
- Female subjects cannot be pregnant, as confirmed by a negative urine pregnancy test at Study Day 1, prior to skin testing.
- Women of childbearing potential may be enrolled if one of the following criteria applies:
- Sexually active male subjects may be enrolled if one of the following criteria applies:
- In addition to the Inclusion Criteria above, Stage II Subjects must also meet the following criteria :
Key exclusion criteria (5 listed)
- Antihistamine use within 14 days of testing. Medications with antihistamine properties (i.e., anticholinergic agents, phenothiazine), beta-blockers, MAO-inhibitors or tricyclic antidepressant use within 1 day of testing.
- Dermatographia, or extreme skin sensitivity.
- History of allergic rhinitis, asthma or eczema.
- Outward signs of active allergies or upper respiratory infection.
- Known pregnancy as confirmed by urine pregnancy testing on Day 1, prior to skin testing procedures.
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 |
|---|---|---|
| Valortim and selected ComponentsAlso: Anthrax* Valortim (Lot #10-08-001, 25 mg/mL) will be filtered through a 0.22 µm syringe filter and diluted 1:1000, 1:100, 1:10, and 1:1 in saline. * Polysorbate 80 will be diluted in saline to the following concentrations: 0.06 mg/mL, 0.2 mg/mL, and 0.6 mg/mL. * Mannitol (30 mg/mL) will be diluted in saline to the following concentrations: 1:1000, 1:100, 1:10, and 1:1 * Histamine (1 mg/mL), positive control * Saline (0.9%), negative control | Biological | Stage I |
| Valortim and Selected ComponentsAlso: Anthrax• It is anticipated that up to 4 subjects that received Valortim in a previous study (#0036-08-05) will participate in Stage II of the study; two of these subjects experienced adverse events while being dosed with Valortim. Subjects will each be tested percutaneously with Valortim, polysorbate 80, mannitol, histamine, and saline. * Only one subject will be skin tested in a single day. * The appropriate dilution for Valortim, mannitol, and polysorbate 80 will be based on the results from Stage I of this study. As was done in Stage I, Valortim will be filtered through a 0.22 µm syringe filter. Histamine (1 mg/mL) and saline (0.9%) will be used as the positive and negative controls, respectively | Drug | Stage II |
Primary outcome
Skin Testing Results
Time frame: Initial results assessed after 15minutes and up to 72 hours.
Assessment of any wheal reaction from the study drug or its selected components and how this compares to the positive and negative control
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 24 Sep 2010.
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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.
Jeffrey Wald, MD principal investigator
Kansas City Allergy and Asthma
Valerie Riddle, MD study director
Sponsor Medical Monitor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Valortim and selected Components in people with Allergic Reactions, run by PharmAthene, Inc. at 1 site in United States.
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 14 inclusion and 5 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 24 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Skin Testing Results (time frame: Initial results assessed after 15minutes and up to 72 hours.). 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 24 Sep 2010.