Trial Outcomes & Findings for A Study to Evaluate the Safety and Microbiology of C16G2 Varnish Administered in Multiple Doses to Dental Subjects (NCT NCT03004365)

Results Overview

Safety will be assessed by performing targeted physical examinations, oral cavity exams, taking vital signs and collection of adverse events categorized according to system organ class (SOC) and preferred term (PT) based on coding to the Medical Dictionary for Regulatory Activities (MedDRA®), Version 17.1. Comprehensive examinations of oral hard and soft tissue structures, as well as targeted exams of specific musculoskeletal and extraoral sites were performed at selected time points; vital signs (blood pressure, heart rate and temperature) were taken at screening, baseline (Visit 3/Day 0) and Visits 4 and 5.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

33 participants

Primary outcome timeframe

Subjects will be followed for safety for 1 week post last study drug administration

Results posted on

2022-12-29

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1A: 27.2 mg C16G2 Subjects in Study Arm 1 will receive up to 1 mL of 27.2 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.	Arm 2A: 13.6 mg C16G2 Subjects in Study Arm 2 will receive up to 1 mL of 13.6 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.	Arm 3A: 54.4 mg C16G2 Subjects in Study Arm 3 will receive up to 1 mL of 54.4 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.	Group: Pooled Placebo Subjects enrolled in Arms 1B (N=3), 2B (N=3) and 3B (N=3) were pooled into one group.
Overall Study STARTED	8	8	8	9
Overall Study COMPLETED	8	8	8	9
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate the Safety and Microbiology of C16G2 Varnish Administered in Multiple Doses to Dental Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 3A: 54.4 mg C16G2 n=8 Participants Subjects in Study Arm 3 will receive up to 1 mL of 54.4 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.	Group: Pooled Placebo n=9 Participants Subjects enrolled in Arms 1B (N=3), 2B (N=3) and 3B (N=3) were pooled into one group.	Total n=33 Participants Total of all reporting groups	Arm 1A: 27.2 mg C16G2 n=8 Participants Subjects in Study Arm 1 will receive up to 1 mL of 27.2 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.	Arm 2A: 13.6 mg C16G2 n=8 Participants Subjects in Study Arm 2 will receive up to 1 mL of 13.6 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.
Age, Continuous	19.4 years n=5 Participants	22.2 years n=4 Participants	24.7 years n=21 Participants	28.7 years n=5 Participants	28.7 years n=7 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	6 Participants n=4 Participants	21 Participants n=21 Participants	6 Participants n=5 Participants	5 Participants n=7 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=4 Participants	12 Participants n=21 Participants	2 Participants n=5 Participants	3 Participants n=7 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	4 Participants n=4 Participants	10 Participants n=21 Participants	2 Participants n=5 Participants	0 Participants n=7 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	5 Participants n=4 Participants	23 Participants n=21 Participants	6 Participants n=5 Participants	8 Participants n=7 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants
Region of Enrollment United States	8 participants n=5 Participants	9 participants n=4 Participants	33 participants n=21 Participants	8 participants n=5 Participants	8 participants n=7 Participants

PRIMARY outcome

Timeframe: Subjects will be followed for safety for 1 week post last study drug administration

Safety will be assessed by performing targeted physical examinations, oral cavity exams, taking vital signs and collection of adverse events categorized according to system organ class (SOC) and preferred term (PT) based on coding to the Medical Dictionary for Regulatory Activities (MedDRA®), Version 17.1. Comprehensive examinations of oral hard and soft tissue structures, as well as targeted exams of specific musculoskeletal and extraoral sites were performed at selected time points; vital signs (blood pressure, heart rate and temperature) were taken at screening, baseline (Visit 3/Day 0) and Visits 4 and 5.

Outcome measures

Outcome measures
Measure	Arm 1A: 27.2 mg C16G2 n=8 Participants Subjects in Study Arm 1 will receive up to 1 mL of 27.2 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.	Arm 2A: 13.6 mg C16G2 n=8 Participants Subjects in Study Arm 2 will receive up to 1 mL of 13.6 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.	Arm 3A: 54.4 mg C16G2 n=8 Participants Subjects in Study Arm 3 will receive up to 1 mL of 54.4 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.	Group: Pooled Placebo n=9 Participants Subjects enrolled in Arms 1B (N=3), 2B (N=3) and 3B (N=3) were pooled into one group.
Safety of Multiple C16G2 Varnish Applications Participants with Adverse Events Related to Study Drug	0 Participants	0 Participants	0 Participants	0 Participants
Safety of Multiple C16G2 Varnish Applications Participants with Clinical Significant Oral Cavity Changes	0 Participants	0 Participants	0 Participants	0 Participants
Safety of Multiple C16G2 Varnish Applications Participants with Clinical Significant Vital Sign Changes	0 Participants	0 Participants	0 Participants	0 Participants
Safety of Multiple C16G2 Varnish Applications Participants with Abnormal Physical Exam Findings	0 Participants	0 Participants	0 Participants	0 Participants
Safety of Multiple C16G2 Varnish Applications Participants with Completed Study	8 Participants	8 Participants	8 Participants	9 Participants

SECONDARY outcome

Timeframe: Subjects will be followed for microbiology for 1 month post last study drug administration

To assess the targeted antimicrobial activity of C16G2 applications as measured by a reduction in Streptococcus mutans in saliva and dental plaque using S. mutans CFUs using mitis-salivarius bacitrain (MSB) agar plating. Streptococcus species present in the oral cavity have been traditionally isolated from oral cavity samples using MSB agar plates. A summary focusing on mean log transformed S. mutans changes from baseline levels in saliva at each assessment time point following the first administration of C16G2.The log transformed changes from baseline S. mutans levels in saliva at each assessment time point following the first administration of C16G2 in each study arm including N, mean, SD, median and range.

Outcome measures

Outcome measures
Measure	Arm 1A: 27.2 mg C16G2 n=8 Participants Subjects in Study Arm 1 will receive up to 1 mL of 27.2 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.	Arm 2A: 13.6 mg C16G2 n=8 Participants Subjects in Study Arm 2 will receive up to 1 mL of 13.6 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.	Arm 3A: 54.4 mg C16G2 n=8 Participants Subjects in Study Arm 3 will receive up to 1 mL of 54.4 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.	Group: Pooled Placebo n=9 Participants Subjects enrolled in Arms 1B (N=3), 2B (N=3) and 3B (N=3) were pooled into one group.
Antimicrobial Activity Against S. Mutans Saliva Sample: S. mutans by MSB Agar Plating	-0.23 log(CFU/mL) Standard Deviation 0.60	-0.08 log(CFU/mL) Standard Deviation 0.54	-0.015 log(CFU/mL) Standard Deviation 0.63	-0.09 log(CFU/mL) Standard Deviation 0.46
Antimicrobial Activity Against S. Mutans Dental Plaque: S. mutans by MSB Agar Plating	-0.51 log(CFU/mL) Standard Deviation 0.8	-0.28 log(CFU/mL) Standard Deviation 0.54	-0.58 log(CFU/mL) Standard Deviation 0.6	-0.59 log(CFU/mL) Standard Deviation 0.74

SECONDARY outcome

Timeframe: Subjects will be followed for microbiology for 1 month post last study drug administration

To assess total bacteria in saliva and dental plaque post study drug administration using total bacteria CFUs using Todd Hewitt (TH) agar plating and the log transformed changes from baseline Total Bacteria levels in dental plaque and saliva including N, mean, SD, median and range at each assessment time point following the first administration of C16G2. A summary focusing on mean log transformed S. mutans changes from baseline levels in saliva at each assessment time point following the first administration of C16G2.

Outcome measures

Outcome measures
Measure	Arm 1A: 27.2 mg C16G2 n=8 Participants Subjects in Study Arm 1 will receive up to 1 mL of 27.2 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.	Arm 2A: 13.6 mg C16G2 n=8 Participants Subjects in Study Arm 2 will receive up to 1 mL of 13.6 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.	Arm 3A: 54.4 mg C16G2 n=8 Participants Subjects in Study Arm 3 will receive up to 1 mL of 54.4 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.	Group: Pooled Placebo n=9 Participants Subjects enrolled in Arms 1B (N=3), 2B (N=3) and 3B (N=3) were pooled into one group.
Antimicrobial Activity Against Total Bacteria Saliva Sample - Total Bacteria by TH Agar Plating	0.21 log(CFU/mL) Standard Deviation 0.49	-0.03 log(CFU/mL) Standard Deviation 0.22	-0.09 log(CFU/mL) Standard Deviation 0.55	0.07 log(CFU/mL) Standard Deviation 0.22
Antimicrobial Activity Against Total Bacteria Dental Plaque - Total Bacteria by TH Agar Plating	-0.46 log(CFU/mL) Standard Deviation 0.69	-0.58 log(CFU/mL) Standard Deviation 0.3	-0.51 log(CFU/mL) Standard Deviation 0.57	-0.24 log(CFU/mL) Standard Deviation 0.56

Adverse Events

Arm 1A: 27.2 mg C16G2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2A: 13.6 mg C16G2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 3A: 54.4 mg C16G2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group: Pooled Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Clinical Operations

Armata Pharmaceuticals, Inc.

Phone: 3106652928

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place