Healthy VolunteersPhase 1NCT02757755
Ascending Dose Study of the Safety of AB-SA01 When Topically Applied to Intact Skin of Healthy Adults
A Phase 1 study testing AB-SA01 (10^8 PFU per phage) and AB-SA01 (10^9 PFU per phage) in people with Healthy Volunteers, run by Armata Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This study will examine the safety of ascending doses of AB-SA01 when topically applied to intact skin of healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- AB-SA01 (10^8 PFU per phage) and AB-SA01 (10^9 PFU per phage)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Aug 2016
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female, 18 to 60 years of age, inclusive, at the time of the first treatment
- Willing and able to sign the informed consent and adhere to the study schedule
- Healthy subject as determined by the principal investigator or designee via medical history and clinical examination before enrollment in the study
- Normal skin of the volar aspect of the forearms, as determined by the principal investigator or designee via examination
- If female, the subject is not pregnant or breastfeeding and has a negative urine pregnancy test at screening, and prior to receiving the first study treatment
- If female of childbearing potential, the subject agrees to use adequate contraception from screening, throughout the study period, and for 30 days after completion of treatment.
- If male, subjects with female partners of childbearing potential must agree to use adequate contraception from screening, throughout the study period, and for 30 days after completion of treatment
Who cannot join
- Any past use of a bacteriophage product, or planned use from the time of screening and during the entire study period
- Planned participation in another clinical trial and/or use of any product that is investigational, drug, biologic or device, within 30 days preceding screening and during the entire study period
- Skin lesions, chronic skin conditions, scars or tattoo placement, as established by skin examination before enrollment in the study that would interfere with study treatment.
- Chronic administration (defined as more than 14 days total in the past 6 months) of immunosuppressant or other immune-modifying drugs within 6 months prior to the first study treatment
- Chronic administration of topical steroids to the volar aspect of the forearms (defined as more than 14 days total in the 6 months prior to the first study treatment)
- Any other prohibited medication or treatment
Show all 19Show fewer
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history, physical examination, and screening serology (HIV, HbsAg, and anti-HCV)
- History of congenital or hereditary immunodeficiency
- History of any severe allergic reaction or hypersensitivity (anaphylaxis)
- History of allergic reaction or irritant contact dermatitis due to wound dressings (eg, adhesive tapes, bandages, gauze)
- History of allergic reaction to castor oil
- Acute disease and/or fever at the time of study treatment
- Acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic, or renal functional abnormality as determined by medical history, physical examination, or laboratory screening tests
- Screening lab results with any Grade 2 or higher abnormality or clinically significant Grade 1 abnormality, as determined by the Common Terminology Criteria for Adverse Events (CTCAE).
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the first study treatment or planned administration during the study period
- Recent (within 12 months prior to screening) history of chronic alcohol abuse, defined as a history of ethanol consumption on average > 40 g/day for women and 60 g/day for men for at least 12 months prior to Baseline.
- Recent (within 12 months prior to screening) history of illicit drug abuse
- Inability to comply with study requirements and restrictions
- Any reason, considered by the principal investigator or designee, to preclude subject involvement in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Trials Center, WRAIR
Silver Spring, Maryland, 20910
About this study
This study will examine the safety of ascending doses of AB-SA01 when topically applied to intact skin of healthy adults.
Read the detailed description
AB-SA01 consists of three bacteriophages (viruses) that target Staphylococcus aureus bacteria.
The safety of AB-SA01 will be assessed when topically administered once daily to the volar aspect of the forearm at a dose of 10^8 plaque forming units (PFU) per phage for 3 consecutive days, and then at a dose of 10^9 plaque forming units (PFU) per phage for 3 consecutive days. Both AB-SA01 and placebo will be administered to each subject to provide his/her own control for evaluation of skin reactions. The right or left placement of the placebo will be randomized and double-blinded.
- Conditions
- Healthy Volunteers
- Being tested
- AB-SA01 (10^8 PFU per phage), AB-SA01 (10^9 PFU per phage), Placebo (for Cohort 10^8), Placebo (for Cohort 10^9)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AB-SA01 (10^8 PFU per phage)Biological
Gauze pads will be saturated with AB-SA01 and then applied to each subject's volar forearm and covered with occlusive dressing once daily for 3 consecutive days. Placement of the gauze to each subject's right or left volar forearm will be randomized and double-blinded.
AB-SA01 (10^9 PFU per phage)Biological
Gauze pads will be saturated with AB-SA01 and then applied to each subject's volar forearm and covered with occlusive dressing once daily for 3 consecutive days. Placement of the gauze to each subject's right or left volar forearm will be randomized and double-blinded.
Placebo (for Cohort 10^8)Biological
Gauze pads will be saturated with Placebo and then applied to each subject's volar forearm and covered with occlusive dressing once daily for 3 consecutive days. Placement of the gauze to each subject's right or left volar forearm will be randomized and double-blinded.
Placebo (for Cohort 10^9)Biological
Gauze pads will be saturated with Placebo and then applied to each subject's volar forearm and covered with occlusive dressing once daily for 3 consecutive days. Placement of the gauze to each subject's right or left volar forearm will be randomized and double-blinded.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 10^8 | Experimental | AB-SA01 (10^8) and Placebo Receives: Biological: AB-SA01 (10^8 PFU per phage); Biological: Placebo (for Cohort 10^8) |
| Cohort 10^9 | Experimental | AB-SA01 (10^9) and Placebo Receives: Biological: AB-SA01 (10^9 PFU per phage); Biological: Placebo (for Cohort 10^9) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Occurrence, intensity, and relationship of adverse events (AEs) from first dose through the End of Study visit
Measured: From first dose through the End of Study visit (Day 14 ± 2 days)
Change from Baseline in Clinical Laboratory Tests
Clinical laboratory tests (hematology, chemistry, and urinalysis)
Measured: Day 0 (pre-dose), Day 3, and Day 14 ± 2 days
Skin Reaction Change from Baseline
skin reaction assessments
Measured: Days 0, 1, and 2 (pre- and post-dose), and on Day 3, Day 7 ± 1 day, and Day 14 ± 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study startMay 2016
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Allocation
- Randomised
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Armata Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Walter Reed Army Institute of Research (WRAIR)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Livezey, MD, Principal investigator, Walter Reed Army Institute of Research (WRAIR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02757755
- Sponsor's protocol ID
- AB-SA01-01
- Other IDs
- WRAIR-2285
- Status last verified
- Aug 2016
- First submitted
- 27 Apr 2016
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ascending Dose Study of the Safety of AB-SA01 When Topically Applied to Intact Skin of Healthy Adults
- ClinicalTrials.gov ID
- NCT02757755
- Acronym / sponsor ID
- AB-SA01-01
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Armata Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Walter Reed Army Institute of Research (WRAIR)
- Study start
- May 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 2 May 2016 (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 study will examine the safety of ascending doses of AB-SA01 when topically applied to intact skin of healthy adults.
Detailed description
AB-SA01 consists of three bacteriophages (viruses) that target Staphylococcus aureus bacteria.
The safety of AB-SA01 will be assessed when topically administered once daily to the volar aspect of the forearm at a dose of 10^8 plaque forming units (PFU) per phage for 3 consecutive days, and then at a dose of 10^9 plaque forming units (PFU) per phage for 3 consecutive days. Both AB-SA01 and placebo will be administered to each subject to provide his/her own control for evaluation of skin reactions. The right or left placement of the placebo will be randomized and double-blinded.
Study design
- Allocation
- Randomised
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 10^8 | Experimental | Biological: AB-SA01 (10^8 PFU per phage), Biological: Placebo (for Cohort 10^8)AB-SA01 (10^8) and Placebo |
| Cohort 10^9 | Experimental | Biological: AB-SA01 (10^9 PFU per phage), Biological: Placebo (for Cohort 10^9)AB-SA01 (10^9) and Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or female, 18 to 60 years of age, inclusive, at the time of the first treatment
- Willing and able to sign the informed consent and adhere to the study schedule
- Healthy subject as determined by the principal investigator or designee via medical history and clinical examination before enrollment in the study
- Normal skin of the volar aspect of the forearms, as determined by the principal investigator or designee via examination
- If female, the subject is not pregnant or breastfeeding and has a negative urine pregnancy test at screening, and prior to receiving the first study treatment
Key exclusion criteria (19 listed)
- Any past use of a bacteriophage product, or planned use from the time of screening and during the entire study period
- Planned participation in another clinical trial and/or use of any product that is investigational, drug, biologic or device, within 30 days preceding screening and during the entire study period
- Skin lesions, chronic skin conditions, scars or tattoo placement, as established by skin examination before enrollment in the study that would interfere with study treatment.
- Chronic administration (defined as more than 14 days total in the past 6 months) of immunosuppressant or other immune-modifying drugs within 6 months prior to the first study treatment
- Chronic administration of topical steroids to the volar aspect of the forearms (defined as more than 14 days total in the 6 months prior to the first study treatment)
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 |
|---|---|---|
| AB-SA01 (10^8 PFU per phage)Gauze pads will be saturated with AB-SA01 and then applied to each subject's volar forearm and covered with occlusive dressing once daily for 3 consecutive days. Placement of the gauze to each subject's right or left volar forearm will be randomized and double-blinded. | Biological | Cohort 10^8 |
| AB-SA01 (10^9 PFU per phage)Gauze pads will be saturated with AB-SA01 and then applied to each subject's volar forearm and covered with occlusive dressing once daily for 3 consecutive days. Placement of the gauze to each subject's right or left volar forearm will be randomized and double-blinded. | Biological | Cohort 10^9 |
| Placebo (for Cohort 10^8)Gauze pads will be saturated with Placebo and then applied to each subject's volar forearm and covered with occlusive dressing once daily for 3 consecutive days. Placement of the gauze to each subject's right or left volar forearm will be randomized and double-blinded. | Biological | Cohort 10^8 |
| Placebo (for Cohort 10^9)Gauze pads will be saturated with Placebo and then applied to each subject's volar forearm and covered with occlusive dressing once daily for 3 consecutive days. Placement of the gauze to each subject's right or left volar forearm will be randomized and double-blinded. | Biological | Cohort 10^9 |
Primary outcome
Adverse Events
Time frame: From first dose through the End of Study visit (Day 14 ± 2 days)
Occurrence, intensity, and relationship of adverse events (AEs) from first dose through the End of Study visit
Change from Baseline in Clinical Laboratory Tests
Time frame: Day 0 (pre-dose), Day 3, and Day 14 ± 2 days
Clinical laboratory tests (hematology, chemistry, and urinalysis)
Skin Reaction Change from Baseline
Time frame: Days 0, 1, and 2 (pre- and post-dose), and on Day 3, Day 7 ± 1 day, and Day 14 ± 2 days
skin reaction assessments
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 31 Aug 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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 Livezey, MD principal investigator
Walter Reed Army Institute of Research (WRAIR)
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 AB-SA01 (10^8 PFU per phage) and AB-SA01 (10^9 PFU per phage) in people with Healthy Volunteers, run by Armata Pharmaceuticals, 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 7 inclusion and 19 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 31 Aug 2016. 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?
Adverse Events (time frame: From first dose through the End of Study visit (Day 14 ± 2 days)). The study lists 3 primary outcomes in all. 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 31 Aug 2016.