Dental CariesPhase 2NCT02509845
Study to Evaluate the Safety and Microbiology of C16G2 in Adolescent and Adult Dental Subjects
A Phase 2 study testing C16G2 in people with Dental Caries, run by Armata Pharmaceuticals, Inc. at 5 sites in United States.
Trial summary
The purpose of the clinical study is to evaluate the safety and bacterial impact of study drug (C16G2) administered in multiple oral gel doses to adolescent and adult dental subjects. Read more about this study
- Who is it for?
- Ages 12 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- C16G2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 5 sitesUnited States
- Study dates
- Jul 2015to Mar 2016
- Phase
- Phase 2
- 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 12 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adolescent Safety Only Cohort: Males and females, 12-17 years of age, inclusive, at the time the Assent and Informed Consent Form is signed. Study Arms 1 \& 2: Males and females, 12-75 years of age, inclusive, at the time the Assent and/or Informed Consent Form is signed
- Female subjects of childbearing potential, defined as not surgically sterile or at least two (2) years postmenopausal, must agree to use one of the following forms of contraception from screening through the last study visit: hormonal (oral, implant, or injection) begun >30 days prior to screening; barrier (condom, diaphragm, or cervical cap with spermicide); intrauterine device (IUD). Acceptable contraceptive options may also include abstinence, relationship with same sex partner or partner who has had a vasectomy at least six (6) months prior to the screening visit
- Male subjects only: willing to use contraception or abstain from sexual activity beginning with the first exposure to study drug and continuing until discharged from the study due to completion or Early Termination
- Healthy, as determined by the Investigator, based on medical and dental history, concurrent illnesses, laboratory results, concomitant medications, oral cavity assessment, and targeted physical examination (extraoral, head and neck) during Screening
- Have a minimum of six unrestored bicuspids and molars with ≤50% of molars and bicuspids having restorations, crowns, sealants or are missing
- Demonstrated ability to expectorate ≥2mL of stimulated saliva in 5 minutes
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- Have a salivary S. mutans of 1.0 x 10e5 CFUs/mL or greater at Screening using MSB agar plating
- Willing to refrain from using non-study dentifrice and other non-study oral care products (oral care rinses, fluoride products, etc.) during the study
- Willing to postpone elective dental procedures (e.g., dental cleanings) between Screening and final post-treatment visit
- Willing and able to comply with oral hygiene and diet instructions
- Has dentition adequate for custom dental tray gel application
- Able to understand and sign the Assent and/or Informed Consent Form prior to initiation of study procedures
- Able to communicate with the Investigator/study center personnel, understand and comply with the study requirements, and willing to return for protocol-specified visits at the appointed times
Who cannot join
- Advanced periodontal disease
- Active caries lesion(s) within 30 days prior to study drug administration (confirmed by comprehensive caries examination including standard radiographs); Note: Subjects presenting with insipient, non-cavitated lesion(s) are not excluded
- Medical condition (e.g., artificial heart valve, history of infective endocarditis, cardiac transplant with valvular dysfunction, congenital heart disease or total joint replacement) for which antibiotics are recommended prior to dental visits and/or procedures
- Pathologic lesions of the oral cavity
- Full or partial dentures, or orthodontic appliances, e.g., night guards, permanent retainers
- Use of systemic antibiotics, topical oral antibiotics, or use of other drugs, which in the opinion of the Investigator could influence the study outcome, within 30 days prior to Screening
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- Medical history indicating the woman is pregnant, breastfeeding/ lactating or has a positive urine pregnancy test
- Participation in a clinical trial or receipt of a non-FDA approved therapy within 30 days prior to study drug administration
- Prior participation in a C16G2 clinical trial and known to have received C16G2 active gel or mouth rinse
- Presence of any condition or concurrent illness, which in the opinion of the Investigator, would compromise normal immune function, interfere with the use of study dentifrice and oral care products, or interfere with the ability to comply with study requirements, or jeopardize the safety of the subject or the validity of the study results
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Indiana University School of Dentistry
Indianapolis, Indiana, 46202
Anthony Henegar, DDS, PA
Irving, Texas, 75063
John F. Pittaway, DMD
Kalispell, Montana, 59901
New York University College of Dentistry
New York, New York, 10010
University of Pennsylvania School of Dental Medicine
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Microbiology of C16G2 Administered in Multiple Oral Gel Doses to Adolescent and Adult Dental Subjects
The purpose of the clinical study is to evaluate the safety and bacterial impact of study drug (C16G2) administered in multiple oral gel doses to adolescent and adult dental subjects.
Read the detailed description
The purpose of the clinical study is to evaluate the safety and microbiology of C16G2 administered in multiple oral gel doses to adolescent and adult dental subjects. Subjects will be assigned to three study cohorts and receive 2 different volumes of C16G2 Gel or Placebo. Prior to commencing enrollment of subjects 12-17 years of age, a safety only cohort of 4-8 adolescent subjects will receive 4 study drug administrations on Day 0. A safety data review will be performed by the Medical Monitor on Days 1 and 5. If no safety concerns are identified, enrollment of adolescent subjects receiving 7 days of study drug administration will be initiated in Study Arms 1 \& 2. Enrollment of adult subjects in Study Arms 1 \& 2 may start before the Adolescent Safety Only Cohort is initiated. Before dosing of study drug, eligible subjects will undergo professional dental prophylaxis on Day 0. Microbiology will be assessed by measuring S. mutans and total bacteria counts.
- Conditions
- Dental Caries
- Being tested
- C16G2, Placebo
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C16G2Drug
Also called Antimicrobial peptide
Antimicrobial peptide
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Adolescent Safety Only Cohort | Experimental | Prior to commencing enrollment of subjects 12-17 years of age in Study Arms 1 \& 2, a safety only cohort of 4 to 8 adolescent subjects will receive 4 administrations of C16G2 on Day 0. Receives: Drug: C16G2; Other: Placebo |
| Study Arm 1 | Experimental | Subjects will receive 2 mL of study drug or placebo over two 7 day C16G2 administration periods, which will be separated by approximately 4 months. Subjects enrolled in Study Arm 1 will receive 4 study drug or placebo administrations on the first day of dosing followed by morning (AM) and evening (PM) dosing for 6 consecutive days. Study drug will be administered via manual toothbrush and custom dental trays. Receives: Drug: C16G2; Other: Placebo |
| Study Arm 2 | Experimental | Subjects will receive 4 mL of study drug or placebo over two 7 day C16G2 administration periods, which will be separated by approximately 4 months. Subjects enrolled in Study Arm 2 will receive 4 study drug or placebo administrations on the first day of dosing followed by morning (AM) and evening (PM) dosing for 6 consecutive days. Study drug will be administered via manual toothbrush and custom dental trays. Receives: Drug: C16G2; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of multiple C16G2 Gel administrations as measured by adverse events
Subjects will be monitored for adverse events throughout the study. At specified clinic visits a targeted physical exam and oral cavity assessment will be performed and vital signs will be taken.
Measured: Screening to week 41
Secondary outcomes (2)
Targeted antimicrobial activity of C16G2 Gel applications as measured by a reduction in Streptococcus mutans in saliva and dental plaque
Measured: Microbiology assessments at screeninig, weeks 1, 2, 4, 8, 12, 13, 27, and 41
Total bacteria in saliva and dental plaque post-study drug administration
Measured: Total bacteria at weeks 1, 2, 13, 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionFeb 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Armata Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Wolff, MD, Principal investigator, New York University, School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02509845
- Sponsor's protocol ID
- C3J15-202-00
- Status last verified
- Jul 2019
- First submitted
- 1 Jul 2015
- Last updated
- 1 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Microbiology of C16G2 Administered in Multiple Oral Gel Doses to Adolescent and Adult Dental Subjects
- ClinicalTrials.gov ID
- NCT02509845
- Acronym / sponsor ID
- C3J15-202-00
- Conditions
- Dental Caries
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Armata Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 28 Jul 2015 (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 the clinical study is to evaluate the safety and bacterial impact of study drug (C16G2) administered in multiple oral gel doses to adolescent and adult dental subjects.
Detailed description
The purpose of the clinical study is to evaluate the safety and microbiology of C16G2 administered in multiple oral gel doses to adolescent and adult dental subjects. Subjects will be assigned to three study cohorts and receive 2 different volumes of C16G2 Gel or Placebo. Prior to commencing enrollment of subjects 12-17 years of age, a safety only cohort of 4-8 adolescent subjects will receive 4 study drug administrations on Day 0. A safety data review will be performed by the Medical Monitor on Days 1 and 5. If no safety concerns are identified, enrollment of adolescent subjects receiving 7 days of study drug administration will be initiated in Study Arms 1 \& 2. Enrollment of adult subjects in Study Arms 1 \& 2 may start before the Adolescent Safety Only Cohort is initiated. Before dosing of study drug, eligible subjects will undergo professional dental prophylaxis on Day 0. Microbiology will be assessed by measuring S. mutans and total bacteria counts.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adolescent Safety Only Cohort | Experimental | Drug: C16G2, Other: PlaceboPrior to commencing enrollment of subjects 12-17 years of age in Study Arms 1 \& 2, a safety only cohort of 4 to 8 adolescent subjects will receive 4 administrations of C16G2 on Day 0. |
| Study Arm 1 | Experimental | Drug: C16G2, Other: PlaceboSubjects will receive 2 mL of study drug or placebo over two 7 day C16G2 administration periods, which will be separated by approximately 4 months. Subjects enrolled in Study Arm 1 will receive 4 study drug or placebo administrations on the first day of dosing followed by morning (AM) and evening (PM) dosing for 6 consecutive days. Study drug will be administered via manual toothbrush and custom dental trays. |
| Study Arm 2 | Experimental | Drug: C16G2, Other: PlaceboSubjects will receive 4 mL of study drug or placebo over two 7 day C16G2 administration periods, which will be separated by approximately 4 months. Subjects enrolled in Study Arm 2 will receive 4 study drug or placebo administrations on the first day of dosing followed by morning (AM) and evening (PM) dosing for 6 consecutive days. Study drug will be administered via manual toothbrush and custom dental trays. |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Adolescent Safety Only Cohort: Males and females, 12-17 years of age, inclusive, at the time the Assent and Informed Consent Form is signed. Study Arms 1 \& 2: Males and females, 12-75 years of age, inclusive, at the time the Assent and/or Informed Consent Form is signed
- Female subjects of childbearing potential, defined as not surgically sterile or at least two (2) years postmenopausal, must agree to use one of the following forms of contraception from screening through the last study visit: hormonal (oral, implant, or injection) begun >30 days prior to screening; barrier (condom, diaphragm, or cervical cap with spermicide); intrauterine device (IUD). Acceptable contraceptive options may also include abstinence, relationship with same sex partner or partner who has had a vasectomy at least six (6) months prior to the screening visit
- Male subjects only: willing to use contraception or abstain from sexual activity beginning with the first exposure to study drug and continuing until discharged from the study due to completion or Early Termination
- Healthy, as determined by the Investigator, based on medical and dental history, concurrent illnesses, laboratory results, concomitant medications, oral cavity assessment, and targeted physical examination (extraoral, head and neck) during Screening
- Have a minimum of six unrestored bicuspids and molars with ≤50% of molars and bicuspids having restorations, crowns, sealants or are missing
Key exclusion criteria (10 listed)
- Advanced periodontal disease
- Active caries lesion(s) within 30 days prior to study drug administration (confirmed by comprehensive caries examination including standard radiographs); Note: Subjects presenting with insipient, non-cavitated lesion(s) are not excluded
- Medical condition (e.g., artificial heart valve, history of infective endocarditis, cardiac transplant with valvular dysfunction, congenital heart disease or total joint replacement) for which antibiotics are recommended prior to dental visits and/or procedures
- Pathologic lesions of the oral cavity
- Full or partial dentures, or orthodontic appliances, e.g., night guards, permanent retainers
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 |
|---|---|---|
| C16G2Also: Antimicrobial peptideAntimicrobial peptide | Drug | Adolescent Safety Only Cohort, Study Arm 1, Study Arm 2 |
| PlaceboPlacebo | Other | Adolescent Safety Only Cohort, Study Arm 1, Study Arm 2 |
Primary outcome
Safety of multiple C16G2 Gel administrations as measured by adverse events
Time frame: Screening to week 41
Subjects will be monitored for adverse events throughout the study. At specified clinic visits a targeted physical exam and oral cavity assessment will be performed and vital signs will be taken.
2 secondary outcomes
Targeted antimicrobial activity of C16G2 Gel applications as measured by a reduction in Streptococcus mutans in saliva and dental plaque
Time frame: Microbiology assessments at screeninig, weeks 1, 2, 4, 8, 12, 13, 27, and 41
Total bacteria in saliva and dental plaque post-study drug administration
Time frame: Total bacteria at weeks 1, 2, 13, 14
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 1 Aug 2019.
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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.
Mark Wolff, MD principal investigator
New York University, School of Dentistry
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing C16G2 in people with Dental Caries, run by Armata Pharmaceuticals, Inc. at 5 sites 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 13 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 1 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Safety of multiple C16G2 Gel administrations as measured by adverse events (time frame: Screening to week 41). 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 1 Aug 2019; AzTrials last refreshed its copy on 8 Nov 2026.