Dental CariesPhase 2NCT02254993

Phase 2, Open-Label Study for Safety, Microbiology and PK of Single or Multiple Oral C16G2 Gel Doses

A Phase 2 study testing C16G2 in people with Dental Caries, run by Armata Pharmaceuticals, Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Part A: Open-label, multiple arm, safety, microbiology and pharmacokinetic (PK) study in healthy adult male and female subjects 18-75 years of age. All subjects will be assessed for safety and microbiology parameters. A subset of subjects will be assessed for pharmacokinetic parameters. Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Dental Caries
What is being tested?: C16G2
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 2 sitesUnited States
Study dates: Oct 2014to Jul 2015
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 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Males and females, 18-75 years of age, inclusive, at the time the Informed Consent Form is signed
Female subjects of childbearing potential, defined as not surgically sterile, 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, monogamous 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 (in consultation with the Medical Monitor, as needed), 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 ≥2 mL of stimulated saliva in 5 minutes

Show all 11Show fewer

Have a salivary S. mutans of 2.0 x 10^4 CFUs/mL or greater (Part A) or 1.0 x 10^5 colony forming unit (CFU)/mL or greater (Part B) at Screening using mitis salivarius-bacitracin (MSB) agar plating
Willing to refrain from using non-study dentifrice and other non-study oral care products during the study
Willing to postpone elective dental procedures (e.g., dental cleanings) between Screening and final post-treatment visit (End of Study or Early Termination)
Able to understand and sign the Informed Consent Form prior to initiation of study procedures
Able to communicate with the Investigator/study site 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 dental examination and standard radiographs)
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 (suspicious or confirmed)
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

Show all 10Show fewer

Medical history indicating the woman is pregnant, breastfeeding/ lactating or she 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 (depending on the specifics, participation in an observational study is not necessarily excluded)
Prior participation in a C16G2 clinical trial and known to have received C16G2 active gel or mouth rinse (Note: placebo subjects are not excluded)
Presence of any condition or concurrent illness, which in the opinion of the Investigator, would compromise normal immune function (e.g., diabetes, rheumatoid arthritis, lupus, liver disease, organ transplant, etc.), interfere with the use of study dentifrice and oral care products, or interfere with the ability to comply with study requirements

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Plaza West II Dental Group
Kalispell, Montana, 59901
Jean Brown Research
Salt Lake City, Utah, 84124

Other trials in United States

About this study

Official title: A Phase 2, Open-Label Study to Evaluate the Safety, Microbiology and Pharmacokinetics of C16G2 Administered in Single or Multiple Oral Gel Doses to Healthy Adult Subjects

Part B: Open-label, multiple arm, safety and microbiology study in healthy adult male and female subjects 18-75 years of age. All subjects will be assessed for safety, pharmacokinetic, and microbiology parameters.

Read the detailed description

Open-label, multiple arm, safety, microbiology and pharmacokinetic (PK) study in healthy adult male and female subjects 18-75 years of age conducted in two parts.

Part A of the study will evaluate up to 6 study arms, depending on the microbiology response evaluated. Before dosing of C16G2, eligible subjects will undergo professional dental prophylaxis on Day 0. Clinic visits for all Study Arms include Visit 1 (Screening/Days -21 to 0), Treatment Visits 2 through 6 (Baseline/Day 0 through Day 4), and follow-up Visits 7 through 11 (Day 5, 8, 12, 19 ± 1 and 33 ± 2).

All subjects will be assessed for safety and microbiology parameters for approximately 5 weeks. A subset of subjects in Study Arms 2 and 4 will be assessed for pharmacokinetic parameters. Part A of the study is no longer enrolling study subjects.

Part B of the study will evaluate up to 5 study arms, depending on the microbiology response evaluated during 2 interim microbiology reviews. Clinic visits for all study arms except Study Arm 5 include Visit 1 (Screening/Days -21 to 0), Visit 2 (Baseline/Day 0), Visits 3 through 17 (Days 1 through 6, morning and evening visits, and Days 7, 10 and 14). All subjects will be assessed for safety and microbiology parameters for approximately 2 weeks. Before dosing of C16G2, eligible subjects will undergo professional dental prophylaxis on Day 0. Study drug will be administered for 7 consecutive days. The Sponsor will perform a microbiology review to evaluate the S. mutans response in Study Arms 1 \& 2 and, if applicable, in Study Arms 3a or 3b. In Study Arm 5, subjects will receive multiple C16G2 doses on a single day and will be evaluated for safety, microbiology and pharmacokinetic parameters. Clinic visits for Study Arm 5 will include Visit 1 (Screening/Days -21 to 0), Visit 2 (Baseline/Day 0), Visit 3/Day 1 and Visit 4/Day 6.

Conditions: Dental Caries
Being tested: C16G2
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 C16G2 (1.6 mg/mL), C16G2 (3.2 mg/mL)
antimicrobial peptide

Study groups in NCT02254993
Study group	Role	What they receive
Arm 1- Part A	Experimental	One 30-minute C16G2 tray gel application (3.2 mg/mL) over the course of five days Receives: Drug: C16G2
Arm 2 - Part A	Experimental	One 4-hour C16G2 tray gel application (3.2 mg/mL) over the course of five days Receives: Drug: C16G2
Arm 3- Part A	Experimental	A single 4-hour C16G2 tray gel application (3.2 mg/mL) Receives: Drug: C16G2
Arm 4- Part A	Experimental	One 4-hour C16G2 tray gel application (1.6 mg/mL) over the course of five days Receives: Drug: C16G2
Arm 5- Part A	Experimental	One 30-minute C16G2 tray gel application (1.6 mg/mL) over the course of five days Receives: Drug: C16G2
Arm 6- Part A	Experimental	One 5-minute C16G2 tray gel application (3.2 mg/mL) over the course of five days Receives: Drug: C16G2
Arm 1 - Part B	Experimental	Four manual brush gel applications on Day 0 followed by twice daily manual brush gel applications (Days 1 through 6); total of 7-day study drug administration, 3.2 mg/mL C16G2 gel concentration. Receives: Drug: C16G2
Arm 2 - Part B	Experimental	Three manual brush gel applications followed by one tray gel application on Day 0. One manual brush application in the morning and one tray gel application in the evening on Days 1 through 6; total of 7-day study drug administration, 3.2 mg/mL C16G2 gel concentration. Receives: Drug: C16G2
Arm 3a or 3b or 3c - Part B	Experimental	Based on the microbiology review, one of 3 study arms will be conducted: Arm 3a: Four manual brush gel applications on Day 0 followed by twice daily manual brush applications (Days 1 through 6); total of 7-day study drug administration, lower C16G2 concentration of 1.6 mg/mL Arm 3b: Three manual brush gel applications followed by one tray gel application on Day 0. One manual brush application in the morning and one tray gel application in the evening on Days 1 through 6; total of 7-day study drug administration, lower C16G2 concentration of 1.6 mg/mL Arm 3c: Three daily manual brush and/or tray gel applications for 7 days, lower C16G2 concentration of 1.6 mg/mL Receives: Drug: C16G2
Arm 4a or 4b - Part B	Experimental	Based on the microbiology review, one of 2 study arms will be conducted: Arm 4a: Four manual brush gel applications on Day 0 followed by twice daily manual brush applications (Days 1 through 6); total of 7-day study drug administration, C16G2 concentration of 1.6 mg/mL and lower gel volume Arm 4b: Three manual brush gel applications followed by one tray gel application on Day 0. One manual brush application in the morning and one tray gel application in the evening on Days 1 through 6; total of 7-day study drug administration, lower C16G2 concentration of 1.6 mg/mL and lower gel volume Receives: Drug: C16G2
Arm 5 - Part B	Experimental	Arm 5: Three manual brush gel applications followed by one tray gel application on Day 0, 3.2 mg/mL C16G2 gel concentration. Receives: Drug: C16G2

What is being measured

The primary outcome is the main question the study is designed to answer.

To evaluate the safety of single and multiple C16G2 Gel administrations in healthy adult subjects
Safety will be assessed by comparing the incidence and duration of adverse events, clinically significant changes in vital signs, oral cavity assessments and targeted physical exams in the 6 study arms
Measured: All subjects will be monitored for safety for approximately 5 weeks (Visit 2 through Visit 11) in Part A, and for 2 weeks (Visit 2 through 17) in Part B of the study

Secondary outcomes (8)

To assess antimicrobial activity of C16G2 Gel applications as measured by a reduction in S. mutans in saliva and dental plaque
All subjects will be assessed for S. mutans levels for approximately 5 weeks (Part A) or 2 weeks (Part B)
Measured: Visit 2 through Visit 11 (Part A) or Visit 17 (Part B)
To assess total bacteria in saliva and dental plaque post-study drug administration
All subjects will be assessed for total bacteria levels for approximately 5 weeks (Part A only)
Measured: Visit 2 through Visit 11 (Part A only)
Peak plasma concentration (Cmax) after multiple daily C16G2 Gel administrations
Five study subjects each in Study Arms 2 and 4 (Part A) and six subjects in Study Arm 5 (Part B). Subjects will be assessed on a single day (Visit 6/Day 4 in Part A and Visit 2/Day 0 in Part B).
Measured: Subjects will be assessed on a single day. PK time points are pre-study drug, during dosing at 5, 30 min, 2 and 4 hrs in Part A and prior to the 1st and 3rd brush, 5 min post 3rd brush, and 15 min and 1.5 hrs after tray
Time to peak plasma concentration (Tmax) after multiple daily C16G2 Gel administrations
Five study subjects each in Study Arms 2 and 4 (Part A) and six subjects in Study Arm 5 (Part B). Subjects will be assessed on a single day (Visit 6/Day 4 in Part A and Visit 2/Day 0 in Part B).
Measured: Subjects will be assessed on a single day. PK time points are pre-study drug, during dosing at 5, 30 min, 2 and 4 hrs in Part A and prior to the 1st and 3rd brush, 5 min post 3rd brush, and 15 min and 1.5 hrs after tray
Area under the curve (AUC) after multiple daily C16G2 Gel administrations
Five study subjects each in Study Arms 2 and 4 (Part A) and six subjects in Study Arm 5 (Part B). Subjects will be assessed on a single day (Visit 6/Day 4 in Part A and Visit 2/Day 0 in Part B).
Measured: Subjects will be assessed on a single day. PK time points are pre-study drug, during dosing at 5, 30 min, 2 and 4 hrs in Part A and prior to the 1st and 3rd brush, 5 min post 3rd brush, and 15 min and 1.5 hrs after tray
Volume of distribution (Vd) after multiple daily C16G2 Gel administrations
Five study subjects each in Study Arms 2 and 4 (Part A) and six subjects in Study Arm 5 (Part B). Subjects will be assessed on a single day (Visit 6/Day 4 in Part A and Visit 2/Day 0 in Part B).
Measured: Subjects will be assessed on a single day. PK time points are pre-study drug, during dosing at 5, 30 min, 2 and 4 hrs in Part A and prior to the 1st and 3rd brush, 5 min post 3rd brush, and 15 min and 1.5 hrs after tray
Elimination half life (t 1/2) after multiple daily C16G2 Gel administrations
Five study subjects each in Study Arms 2 and 4 (Part A) and six subjects in Study Arm 5 (Part B). Subjects will be assessed on a single day (Visit 6/Day 4 in Part A and Visit 2/Day 0 in Part B).
Measured: Subjects will be assessed on a single day. PK time points are pre-study drug, during dosing at 5, 30 min, 2 and 4 hrs in Part A and prior to the 1st and 3rd brush, 5 min post 3rd brush, and 15 min and 1.5 hrs after tray
Clearance (Cl) after multiple daily C16G2 Gel administrations
Five study subjects each in Study Arms 2 and 4 (Part A) and six subjects in Study Arm 5 (Part B). Subjects will be assessed on a single day (Visit 6/Day 4 in Part A and Visit 2/Day 0 in Part B).
Measured: Subjects will be assessed on a single day. PK time points are pre-study drug, during dosing at 5, 30 min, 2 and 4 hrs in Part A and prior to the 1st and 3rd brush, 5 min post 3rd brush, and 15 min and 1.5 hrs after tray

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2014Jul 2015

First posted2 Oct 2014 (estimated)
Study startOct 2014
Primary completionJun 2015
Study completionJul 2015

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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02254993
Sponsor's protocol ID: C3J14-201B-00
Status last verified: Jul 2019
First submitted: 24 Sep 2014
Last updated: 1 Aug 2019
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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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, Open-Label Study to Evaluate the Safety, Microbiology and Pharmacokinetics of C16G2 Administered in Single or Multiple Oral Gel Doses to Healthy Adult Subjects
ClinicalTrials.gov ID: NCT02254993
Acronym / sponsor ID: C3J14-201B-00
Conditions: Dental Caries
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: Armata Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: Oct 2014
Primary completion: Jun 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 2 Oct 2014 (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.

Detailed description

Open-label, multiple arm, safety, microbiology and pharmacokinetic (PK) study in healthy adult male and female subjects 18-75 years of age conducted in two parts.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 11

Arm	Type	Receives
Arm 1- Part A	Experimental	Drug: C16G2One 30-minute C16G2 tray gel application (3.2 mg/mL) over the course of five days
Arm 2 - Part A	Experimental	Drug: C16G2One 4-hour C16G2 tray gel application (3.2 mg/mL) over the course of five days
Arm 3- Part A	Experimental	Drug: C16G2A single 4-hour C16G2 tray gel application (3.2 mg/mL)
Arm 4- Part A	Experimental	Drug: C16G2One 4-hour C16G2 tray gel application (1.6 mg/mL) over the course of five days
Arm 5- Part A	Experimental	Drug: C16G2One 30-minute C16G2 tray gel application (1.6 mg/mL) over the course of five days
Arm 6- Part A	Experimental	Drug: C16G2One 5-minute C16G2 tray gel application (3.2 mg/mL) over the course of five days
Arm 1 - Part B	Experimental	Drug: C16G2Four manual brush gel applications on Day 0 followed by twice daily manual brush gel applications (Days 1 through 6); total of 7-day study drug administration, 3.2 mg/mL C16G2 gel concentration.
Arm 2 - Part B	Experimental	Drug: C16G2Three manual brush gel applications followed by one tray gel application on Day 0. One manual brush application in the morning and one tray gel application in the evening on Days 1 through 6; total of 7-day study drug administration, 3.2 mg/mL C16G2 gel concentration.
Arm 3a or 3b or 3c - Part B	Experimental	Drug: C16G2Based on the microbiology review, one of 3 study arms will be conducted: Arm 3a: Four manual brush gel applications on Day 0 followed by twice daily manual brush applications (Days 1 through 6); total of 7-day study drug administration, lower C16G2 concentration of 1.6 mg/mL Arm 3b: Three manual brush gel applications followed by one tray gel application on Day 0. One manual brush application in the morning and one tray gel application in the evening on Days 1 through 6; total of 7-day study drug administration, lower C16G2 concentration of 1.6 mg/mL Arm 3c: Three daily manual brush and/or tray gel applications for 7 days, lower C16G2 concentration of 1.6 mg/mL
Arm 4a or 4b - Part B	Experimental	Drug: C16G2Based on the microbiology review, one of 2 study arms will be conducted: Arm 4a: Four manual brush gel applications on Day 0 followed by twice daily manual brush applications (Days 1 through 6); total of 7-day study drug administration, C16G2 concentration of 1.6 mg/mL and lower gel volume Arm 4b: Three manual brush gel applications followed by one tray gel application on Day 0. One manual brush application in the morning and one tray gel application in the evening on Days 1 through 6; total of 7-day study drug administration, lower C16G2 concentration of 1.6 mg/mL and lower gel volume
Arm 5 - Part B	Experimental	Drug: C16G2Arm 5: Three manual brush gel applications followed by one tray gel application on Day 0, 3.2 mg/mL C16G2 gel concentration.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Males and females, 18-75 years of age, inclusive, at the time the Informed Consent Form is signed
Female subjects of childbearing potential, defined as not surgically sterile, 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, monogamous 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 (in consultation with the Medical Monitor, as needed), 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 dental examination and standard radiographs)
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 (suspicious or confirmed)
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: C16G2 (1.6 mg/mL), C16G2 (3.2 mg/mL)antimicrobial peptide	Drug	Arm 1 - Part B, Arm 1- Part A, Arm 2 - Part A, Arm 2 - Part B, Arm 3- Part A, Arm 3a or 3b or 3c - Part B, Arm 4- Part A, Arm 4a or 4b - Part B, Arm 5 - Part B, Arm 5- Part A, Arm 6- Part A

Primary outcome

To evaluate the safety of single and multiple C16G2 Gel administrations in healthy adult subjects
Time frame: All subjects will be monitored for safety for approximately 5 weeks (Visit 2 through Visit 11) in Part A, and for 2 weeks (Visit 2 through 17) in Part B of the study
Safety will be assessed by comparing the incidence and duration of adverse events, clinically significant changes in vital signs, oral cavity assessments and targeted physical exams in the 6 study arms

8 secondary outcomes

To assess antimicrobial activity of C16G2 Gel applications as measured by a reduction in S. mutans in saliva and dental plaque
Time frame: Visit 2 through Visit 11 (Part A) or Visit 17 (Part B)
To assess total bacteria in saliva and dental plaque post-study drug administration
Time frame: Visit 2 through Visit 11 (Part A only)
Peak plasma concentration (Cmax) after multiple daily C16G2 Gel administrations
Time frame: Subjects will be assessed on a single day. PK time points are pre-study drug, during dosing at 5, 30 min, 2 and 4 hrs in Part A and prior to the 1st and 3rd brush, 5 min post 3rd brush, and 15 min and 1.5 hrs after tray
Time to peak plasma concentration (Tmax) after multiple daily C16G2 Gel administrations
Time frame: Subjects will be assessed on a single day. PK time points are pre-study drug, during dosing at 5, 30 min, 2 and 4 hrs in Part A and prior to the 1st and 3rd brush, 5 min post 3rd brush, and 15 min and 1.5 hrs after tray
Area under the curve (AUC) after multiple daily C16G2 Gel administrations
Time frame: Subjects will be assessed on a single day. PK time points are pre-study drug, during dosing at 5, 30 min, 2 and 4 hrs in Part A and prior to the 1st and 3rd brush, 5 min post 3rd brush, and 15 min and 1.5 hrs after tray
Volume of distribution (Vd) after multiple daily C16G2 Gel administrations
Time frame: Subjects will be assessed on a single day. PK time points are pre-study drug, during dosing at 5, 30 min, 2 and 4 hrs in Part A and prior to the 1st and 3rd brush, 5 min post 3rd brush, and 15 min and 1.5 hrs after tray
Elimination half life (t 1/2) after multiple daily C16G2 Gel administrations
Time frame: Subjects will be assessed on a single day. PK time points are pre-study drug, during dosing at 5, 30 min, 2 and 4 hrs in Part A and prior to the 1st and 3rd brush, 5 min post 3rd brush, and 15 min and 1.5 hrs after tray
Clearance (Cl) after multiple daily C16G2 Gel administrations
Time frame: Subjects will be assessed on a single day. PK time points are pre-study drug, during dosing at 5, 30 min, 2 and 4 hrs in Part A and prior to the 1st and 3rd brush, 5 min post 3rd brush, and 15 min and 1.5 hrs after tray

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.

Adam D Marberger, DDS principal investigator

Study Center PI

John F Pittaway, DMD principal investigator

Study Center PI

2 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 2 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 11 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 2 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?

To evaluate the safety of single and multiple C16G2 Gel administrations in healthy adult subjects (time frame: All subjects will be monitored for safety for approximately 5 weeks (Visit 2 through Visit 11) in Part A, and for 2 weeks (Visit 2 through 17) in Part B of the study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02254993.

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.