Trial Outcomes & Findings for Safety, Tolerability and PK of Intravenous (IV) ETI-204 Alone and in Presence of Ciprofloxacin in Adult Volunteers (NCT NCT01952444)

NCT ID: NCT01952444

Last Updated: 2019-04-16

Results Overview

Safety was assessed for all subjects in the Safety Population by collecting and monitoring vital signs, clinical laboratory tests, ECGs, physical assessments, skin assessments, infusion site assessments, and adverse events (AEs).

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 40 participants
• Primary outcome timeframe: Up to 71 days or 101 days (30 days after the final study visit) for subjects with ongoing adverse events at the final study visit, for each group.
• Results posted on: 2019-04-16

Participant Flow

Participant milestones

Measure	ETI-204 IV infusion of 16 mg/kg ETI-204 IV Ciprofloxacin: IV Infusion of 400 mg ciprofloxacin Oral Ciprofloxacin: Oral ciprofloxacin (750 mg) every 12 hours on Days 2-8 and final dose on morning of Day 9	ETI-204 and Ciprofloxacin IV infusion of 16 mg/kg ETI-204 followed by IV infusion of ciprofloxacin followed by oral ciprofloxacin ETI-204: IV infusion of 16 mg/kg ETI-204
Overall Study STARTED	20	20
Overall Study COMPLETED	20	19
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety, Tolerability and PK of Intravenous (IV) ETI-204 Alone and in Presence of Ciprofloxacin in Adult Volunteers

Baseline characteristics by cohort

Measure	ETI-204 n=20 Participants Participants received 16 mg/kg ETI-2041 by IV infusion over 90 minutes	ETI-204 + Ciprofloxacin n=20 Participants Participants received 16 mg/kg ETI-204 by IV infusion over 90 minutes followed by IV infusion of 400 mg ciprofloxacin followed by oral ciprofloxacin (750 mg) every 12 hours on Days 2-8 and a final dose on the morning of Day 9	Total n=40 Participants Total of all reporting groups
Age, Continuous	33 years STANDARD_DEVIATION 11.8 • n=5 Participants	33 years STANDARD_DEVIATION 14.0 • n=7 Participants	33 years STANDARD_DEVIATION 12.8 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants	14 Participants n=7 Participants	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants
Body Weight	78.4 kg STANDARD_DEVIATION 16.63 • n=5 Participants	75.8 kg STANDARD_DEVIATION 18.26 • n=7 Participants	77.1 kg STANDARD_DEVIATION 17.29 • n=5 Participants
Height	169.5 cm STANDARD_DEVIATION 7.29 • n=5 Participants	169.4 cm STANDARD_DEVIATION 9.11 • n=7 Participants	169.4 cm STANDARD_DEVIATION 8.15 • n=5 Participants
BMI	27.1 kg/m2 STANDARD_DEVIATION 4.80 • n=5 Participants	26.2 kg/m2 STANDARD_DEVIATION 4.75 • n=7 Participants	26.7 kg/m2 STANDARD_DEVIATION 4.74 • n=5 Participants

PRIMARY outcome

Timeframe: Up to 71 days or 101 days (30 days after the final study visit) for subjects with ongoing adverse events at the final study visit, for each group.

Population: All randomized subjects who received study drug were included in the Safety Population.

Safety was assessed for all subjects in the Safety Population by collecting and monitoring vital signs, clinical laboratory tests, ECGs, physical assessments, skin assessments, infusion site assessments, and adverse events (AEs).

Outcome measures

Measure	ETI-204 + Ciprofloxacin n=20 Participants Participants received 16 mg/kg ETI-204 by IV infusion over 90 minutes followed by IV infusion of 400 mg ciprofloxacin followed by oral ciprofloxacin (750 mg) every 12 hours on Days 2-8 and a final dose on the morning of Day 9. All participants received 50 mg oral diphenhydramine as a required premedication before ETI-204 infusion.	ETI-204 n=20 Participants Participants received 16 mg/kg ETI-204 by IV infusion over 90 minutes. All participants received 50 mg oral diphenhydramine as a required premedication before ETI-204 infusion.
Number of Participants Who Experienced Adverse Events	14 Participants	13 Participants

SECONDARY outcome

Timeframe: On Day 1 at predose, at the end of ETI-204 infusion, 2.5, 4.5 and 7.5 hours after the start of the ETI-204 infusion, and on Days 2 (24 hours), 9, 16, 29, 43, and 71.

Population: The Pharmacokinetic (PK) Population consisted of all subjects who received ETI-204 and had at least one valid PK parameter. Two subjects in the ETI-204 + ciprofloxacin group received partial doses of ETI-204 (discontinued study drug due to AEs) and were excluded from the PK Population.

Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.

Outcome measures

Measure	ETI-204 + Ciprofloxacin n=18 Participants Participants received 16 mg/kg ETI-204 by IV infusion over 90 minutes followed by IV infusion of 400 mg ciprofloxacin followed by oral ciprofloxacin (750 mg) every 12 hours on Days 2-8 and a final dose on the morning of Day 9. All participants received 50 mg oral diphenhydramine as a required premedication before ETI-204 infusion.	ETI-204 n=20 Participants Participants received 16 mg/kg ETI-204 by IV infusion over 90 minutes. All participants received 50 mg oral diphenhydramine as a required premedication before ETI-204 infusion.
Maximum Observed Plasma Concentration of ETI-204 (Cmax)	397 µg/mL Standard Deviation 63.7	402 µg/mL Standard Deviation 91.0

SECONDARY outcome

Timeframe: On Day 1 at predose, at the end of ETI-204 infusion, 2.5, 4.5 and 7.5 hours after the start of the ETI-204 infusion, and on Days 2 (24 hours), 9, 16, 29, 43, and 71.

Population: The PK Population consisted of all subjects who received ETI-204 and had at least one valid PK parameter. Two subjects in the ETI-204 + ciprofloxacin group received partial doses of ETI-204 (discontinued study drug due to AEs) and were excluded from the PK Population.

Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.

Outcome measures

Measure	ETI-204 + Ciprofloxacin n=18 Participants Participants received 16 mg/kg ETI-204 by IV infusion over 90 minutes followed by IV infusion of 400 mg ciprofloxacin followed by oral ciprofloxacin (750 mg) every 12 hours on Days 2-8 and a final dose on the morning of Day 9. All participants received 50 mg oral diphenhydramine as a required premedication before ETI-204 infusion.	ETI-204 n=20 Participants Participants received 16 mg/kg ETI-204 by IV infusion over 90 minutes. All participants received 50 mg oral diphenhydramine as a required premedication before ETI-204 infusion.
Time to Maximum Observed Plasma Concentration of ETI-204 (Tmax)	0.104 days Interval 0.0625 to 1.0	0.104 days Interval 0.0625 to 1.0

SECONDARY outcome

Timeframe: On Day 1 at predose, at the end of ETI-204 infusion, 2.5, 4.5 and 7.5 hours after the start of the ETI-204 infusion, and on Days 2 (24 hours), 9, 16, 29, 43, and 71.

Population: All subjects who received ETI-204 and had at least one valid PK parameter were included in the PK Population: Two subjects who received a partial dose of ETI-204 due to AEs and 1 who withdrew prematurely on Day 1 for personal reasons after the IV infusions of ETI-204 and ciprofloxacin were excluded from the ETI-204 + ciprofloxacin group.

Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.

Outcome measures

Measure	ETI-204 + Ciprofloxacin n=17 Participants Participants received 16 mg/kg ETI-204 by IV infusion over 90 minutes followed by IV infusion of 400 mg ciprofloxacin followed by oral ciprofloxacin (750 mg) every 12 hours on Days 2-8 and a final dose on the morning of Day 9. All participants received 50 mg oral diphenhydramine as a required premedication before ETI-204 infusion.	ETI-204 n=20 Participants Participants received 16 mg/kg ETI-204 by IV infusion over 90 minutes. All participants received 50 mg oral diphenhydramine as a required premedication before ETI-204 infusion.
Area Under the Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUC0-last))	4603 µg.day/mL Standard Deviation 791	4514 µg.day/mL Standard Deviation 792

SECONDARY outcome

Timeframe: On Day 1 at predose, at the end of ETI-204 infusion, 2.5, 4.5 and 7.5 hours after the start of the ETI-204 infusion, and on Days 2 (24 hours), 9, 16, 29, 43, and 71.

Population: All subjects for whom Cmax, Tmax and AUC0-last were calculated minus 2 subjects (1 in the ETI-204 group and 1 in the ETI-204 + ciprofloxacin group) whose t1/2 values were \> than 50% of the total sample collection interval. AUC0-inf and AUC0-inf-based parameters were not reported for those subjects in accordance with the statistical analysis plan.

Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.

Outcome measures

Measure	ETI-204 + Ciprofloxacin n=16 Participants Participants received 16 mg/kg ETI-204 by IV infusion over 90 minutes followed by IV infusion of 400 mg ciprofloxacin followed by oral ciprofloxacin (750 mg) every 12 hours on Days 2-8 and a final dose on the morning of Day 9. All participants received 50 mg oral diphenhydramine as a required premedication before ETI-204 infusion.	ETI-204 n=19 Participants Participants received 16 mg/kg ETI-204 by IV infusion over 90 minutes. All participants received 50 mg oral diphenhydramine as a required premedication before ETI-204 infusion.
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf)	4990 µg.day/mL Standard Deviation 942	4891 µg.day/mL Standard Deviation 897

SECONDARY outcome

Timeframe: On Day 1 at predose, at the end of ETI-204 infusion, 2.5, 4.5 and 7.5 hours after the start of the ETI-204 infusion, and on Days 2 (24 hours), 9, 16, 29, 43, and 71.

Population: All subjects for whom Cmax, Tmax and AUC0-last were calculated minus 2 subjects (1 in the ETI-204 group and 1 in the ETI-204 + ciprofloxacin group) whose t1/2 values were \> than 50% of the total sample collection interval. AUC0-inf and AUC0-inf-based parameters were not reported for those subjects in accordance with the statistical analysis plan.

Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.

Outcome measures

Measure	ETI-204 + Ciprofloxacin n=16 Participants Participants received 16 mg/kg ETI-204 by IV infusion over 90 minutes followed by IV infusion of 400 mg ciprofloxacin followed by oral ciprofloxacin (750 mg) every 12 hours on Days 2-8 and a final dose on the morning of Day 9. All participants received 50 mg oral diphenhydramine as a required premedication before ETI-204 infusion.	ETI-204 n=19 Participants Participants received 16 mg/kg ETI-204 by IV infusion over 90 minutes. All participants received 50 mg oral diphenhydramine as a required premedication before ETI-204 infusion.
Terminal Half-life (t1/2)	19.0 days Standard Deviation 3.00	19.5 days Standard Deviation 4.14

SECONDARY outcome

Timeframe: On Day 1 at predose, at the end of ETI-204 infusion, 2.5, 4.5 and 7.5 hours after the start of the ETI-204 infusion, and on Days 2 (24 hours), 9, 16, 29, 43, and 71.

Population: All subjects for whom Cmax, Tmax and AUC0-last were calculated minus 2 subjects (1 in the ETI-204 group and 1 in the ETI-204 + ciprofloxacin group) whose t1/2 values were \> than 50% of the total sample collection interval. AUC0-inf and AUC0-inf-based parameters were not reported for those subjects in accordance with the statistical analysis plan.

Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.

Outcome measures

Measure	ETI-204 + Ciprofloxacin n=16 Participants Participants received 16 mg/kg ETI-204 by IV infusion over 90 minutes followed by IV infusion of 400 mg ciprofloxacin followed by oral ciprofloxacin (750 mg) every 12 hours on Days 2-8 and a final dose on the morning of Day 9. All participants received 50 mg oral diphenhydramine as a required premedication before ETI-204 infusion.	ETI-204 n=19 Participants Participants received 16 mg/kg ETI-204 by IV infusion over 90 minutes. All participants received 50 mg oral diphenhydramine as a required premedication before ETI-204 infusion.
Systemic Clearance (CL)	0.247 Liters/day Standard Deviation 0.0732	0.268 Liters/day Standard Deviation 0.0583

SECONDARY outcome

Timeframe: On Day 1 at predose, at the end of ETI-204 infusion, 2.5, 4.5 and 7.5 hours after the start of the ETI-204 infusion, and on Days 2 (24 hours), 9, 16, 29, 43, and 71.

Population: All subjects for whom Cmax, Tmax and AUC0-last were calculated minus 2 subjects (1 in the ETI-204 group and 1 in the ETI-204 + ciprofloxacin group) whose t1/2 values were \> than 50% of the total sample collection interval. AUC0-inf and AUC0-inf-based parameters were not reported for those subjects in accordance with the statistical analysis plan.

Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.

Outcome measures

Measure	ETI-204 + Ciprofloxacin n=16 Participants Participants received 16 mg/kg ETI-204 by IV infusion over 90 minutes followed by IV infusion of 400 mg ciprofloxacin followed by oral ciprofloxacin (750 mg) every 12 hours on Days 2-8 and a final dose on the morning of Day 9. All participants received 50 mg oral diphenhydramine as a required premedication before ETI-204 infusion.	ETI-204 n=19 Participants Participants received 16 mg/kg ETI-204 by IV infusion over 90 minutes. All participants received 50 mg oral diphenhydramine as a required premedication before ETI-204 infusion.
Volume of Distribution (Vd)	6.59 Liters Standard Deviation 1.34	7.57 Liters Standard Deviation 2.58

SECONDARY outcome

Timeframe: On Day 1 at predose, at the end of ETI-204 infusion, 2.5, 4.5 and 7.5 hours after the start of the ETI-204 infusion, and on Days 2 (24 hours), 9, 16, 29, 43, and 71.

Population: All subjects for whom Cmax, Tmax and AUC0-last were calculated minus 2 subjects (1 in the ETI-204 group and 1 in the ETI-204 + ciprofloxacin group) whose t1/2 values were \> than 50% of the total sample collection interval. AUC0-inf and AUC0-inf-based parameters were not reported for those subjects in accordance with the statistical analysis plan.

Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.

Outcome measures

Measure	ETI-204 + Ciprofloxacin n=16 Participants Participants received 16 mg/kg ETI-204 by IV infusion over 90 minutes followed by IV infusion of 400 mg ciprofloxacin followed by oral ciprofloxacin (750 mg) every 12 hours on Days 2-8 and a final dose on the morning of Day 9. All participants received 50 mg oral diphenhydramine as a required premedication before ETI-204 infusion.	ETI-204 n=19 Participants Participants received 16 mg/kg ETI-204 by IV infusion over 90 minutes. All participants received 50 mg oral diphenhydramine as a required premedication before ETI-204 infusion.
Volume of Distribution at Steady State (Vss)	5.68 Liters Standard Deviation 0.986	6.28 Liters Standard Deviation 1.68

SECONDARY outcome

Timeframe: On Day 1 at predose and on Days 9, 29, 43, and 71.

Population: All subjects who received ETI-204 and were included in the Safety Population.

Serum anti-ETI-204 antibody titers were determined for all subjects in the Safety Population. Blood samples were collected and serum samples were assayed at an initial dilution of 1:10. Samples that were positive at the 1:10 dilution were serially diluted 1:2 and assayed until a negative result was attained. The titer of the most dilute sample yielding a positive result was recorded as the titer for that time point. Immunogenicity was measured by the number of participants in each study arm with anti-ETI-204 antibody values post-treatment ≥ 4-times higher than baseline at Day 8, 43 or 71, or if the titer was negative at baseline, the post-treatment sample(s) required a titer of at least 1:20 for it to be considered positive.

Outcome measures

Measure	ETI-204 + Ciprofloxacin n=20 Participants Participants received 16 mg/kg ETI-204 by IV infusion over 90 minutes followed by IV infusion of 400 mg ciprofloxacin followed by oral ciprofloxacin (750 mg) every 12 hours on Days 2-8 and a final dose on the morning of Day 9. All participants received 50 mg oral diphenhydramine as a required premedication before ETI-204 infusion.	ETI-204 n=20 Participants Participants received 16 mg/kg ETI-204 by IV infusion over 90 minutes. All participants received 50 mg oral diphenhydramine as a required premedication before ETI-204 infusion.
Number of Participants With Anti-ETI-204 Antibodies	0 Participants	1 Participants

Adverse Events

ETI-204 + Ciprofloxacin

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

ETI-204 Alone

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	ETI-204 + Ciprofloxacin n=20 participants at risk Participants received 16 mg/kg ETI-204 by IV infusion over 90 minutes followed by IV infusion of 400 mg ciprofloxacin followed by oral ciprofloxacin (750 mg) every 12 hours on Days 2-8 and a final dose on the morning of Day 9	ETI-204 Alone n=20 participants at risk Participants received 16 mg/kg ETI-2041 by IV infusion over 90 minutes
Nervous system disorders Somnolence	25.0% 5/20 • Number of events 5 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.	30.0% 6/20 • Number of events 6 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.
Infections and infestations Upperrespiratory tract infection	10.0% 2/20 • Number of events 2 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.	25.0% 5/20 • Number of events 6 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.
Skin and subcutaneous tissue disorders Urticaria	15.0% 3/20 • Number of events 3 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.	0.00% 0/20 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.
Gastrointestinal disorders Diarrhoea	10.0% 2/20 • Number of events 3 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.	0.00% 0/20 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.
Musculoskeletal and connective tissue disorders Back pain	5.0% 1/20 • Number of events 1 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.	5.0% 1/20 • Number of events 1 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.
Skin and subcutaneous tissue disorders Dermatitis contact	5.0% 1/20 • Number of events 1 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.	5.0% 1/20 • Number of events 1 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.
Nervous system disorders Headache	5.0% 1/20 • Number of events 1 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.	5.0% 1/20 • Number of events 1 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.
Gastrointestinal disorders Nausea	10.0% 2/20 • Number of events 2 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.	0.00% 0/20 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.
Gastrointestinal disorders Anal fissure	5.0% 1/20 • Number of events 1 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.	0.00% 0/20 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/20 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.	5.0% 1/20 • Number of events 1 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.
General disorders Chest discomfort	5.0% 1/20 • Number of events 1 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.	0.00% 0/20 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/20 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.	5.0% 1/20 • Number of events 1 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.
Metabolism and nutrition disorders Decreased appetite	5.0% 1/20 • Number of events 1 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.	0.00% 0/20 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.
Nervous system disorders Dizziness postural	5.0% 1/20 • Number of events 1 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.	0.00% 0/20 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.
Nervous system disorders Dysarthria	5.0% 1/20 • Number of events 1 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.	0.00% 0/20 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.
Nervous system disorders Dysgeusia	5.0% 1/20 • Number of events 1 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.	0.00% 0/20 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.
General disorders Fatigue	5.0% 1/20 • Number of events 1 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.	0.00% 0/20 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.
Infections and infestations Laryngitis	5.0% 1/20 • Number of events 1 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.	0.00% 0/20 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.
Musculoskeletal and connective tissue disorders Muscle twitching	5.0% 1/20 • Number of events 1 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.	0.00% 0/20 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/20 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.	5.0% 1/20 • Number of events 1 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/20 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.	5.0% 1/20 • Number of events 1 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.
Cardiac disorders Palpitations	5.0% 1/20 • Number of events 1 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.	0.00% 0/20 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.
Infections and infestations Pneumonia	0.00% 0/20 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.	5.0% 1/20 • Number of events 1 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.
Gastrointestinal disorders Toothache	5.0% 1/20 • Number of events 1 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.	0.00% 0/20 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.
Infections and infestations Vaginitis bacterial	0.00% 0/20 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.	5.0% 1/20 • Number of events 1 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.
General disorders Vessel puncture site bruise	0.00% 0/20 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.	5.0% 1/20 • Number of events 1 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.
Infections and infestations Vulvovaginal mycotic infection	5.0% 1/20 • Number of events 1 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.	0.00% 0/20 • 71 days or up to 101 days (30 days after the final study visit) for adverse events ongoing at the final study visit, for each group.

Additional Information

Senior Director of Regulatory

Elusys Therapeutics Inc.

Phone: 973-808-0222

Email: cdillon@elusys.com

Results disclosure agreements

• Principal investigator is a sponsor employee The data generated in this clinical study are the exclusive property of the Sponsor and are confidential. Written approval from the Sponsor is required prior to disclosing any information related to this clinical study.
• Publication restrictions are in place

Restriction type: OTHER