Trial Outcomes & Findings for Relative Exposure and Safety Study of Kimyrsa in ABSSSI Patients (NCT NCT03873987)

NCT ID: NCT03873987

Last Updated: 2021-04-13

Results Overview

Relative exposure of AUC of the new formulation to the approved formulation of oritavancin based on area under the plasma concentration-time curve from time zero to 72 hr (AUC0-72)

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 102 participants
• Primary outcome timeframe: 72 hours
• Results posted on: 2021-04-13

Participant Flow

Participant milestones

Measure	Current Formulation of Oritavancin Three single-use vials, each containing 400 mg (1200 mg total) of oritavancin diphosphate (as the free base) and the inactive component mannitol. Oritavancin vials will be reconstituted with SWFI and further diluted in D5W for a total volume of 1000 mL and infused intravenously over 3 hours. Current Formulation of Oritavancin: Current formulation of oritavancin (3 hour infusion of 1200 mg in 1000 ml of D5W)	New Formulation of Oritavancin A single vial containing 1200 mg of oritavancin, HPβCD, and mannitol. Oritavancin vials will be reconstituted with SWFI and further diluted with 0.9% sodium chloride for a total volume of 250 mL and infused intravenously over 1 hour. New Formulation of Oritavancin: New formulation of oritavancin (1 hour infusion of 1200 mg in 250 ml of saline)
Overall Study STARTED	52	50
Overall Study COMPLETED	50	49
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Measure	Current Formulation of Oritavancin Three single-use vials, each containing 400 mg (1200 mg total) of oritavancin diphosphate (as the free base) and the inactive component mannitol. Oritavancin vials will be reconstituted with SWFI and further diluted in D5W for a total volume of 1000 mL and infused intravenously over 3 hours. Current Formulation of Oritavancin: Current formulation of oritavancin (3 hour infusion of 1200 mg in 1000 ml of D5W)	New Formulation of Oritavancin A single vial containing 1200 mg of oritavancin, HPβCD, and mannitol. Oritavancin vials will be reconstituted with SWFI and further diluted with 0.9% sodium chloride for a total volume of 250 mL and infused intravenously over 1 hour. New Formulation of Oritavancin: New formulation of oritavancin (1 hour infusion of 1200 mg in 250 ml of saline)
Overall Study Adverse Event	1	0
Overall Study staff was unable to start a new IV line	1	0
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Relative Exposure and Safety Study of Kimyrsa in ABSSSI Patients

Baseline characteristics by cohort

Measure	Current Formulation of Oritavancin n=52 Participants Three single-use vials, each containing 400 mg (1200 mg total) of oritavancin diphosphate (as the free base) and the inactive component mannitol. Oritavancin vials will be reconstituted with SWFI and further diluted in D5W for a total volume of 1000 mL and infused intravenously over 3 hours. Current Formulation of Oritavancin: Current formulation of oritavancin (3 hour infusion of 1200 mg in 1000 ml of D5W)	New Formulation of Oritavancin n=50 Participants A single vial containing 1200 mg of oritavancin, HPβCD, and mannitol. Oritavancin vials will be reconstituted with SWFI and further diluted with 0.9% sodium chloride for a total volume of 250 mL and infused intravenously over 1 hour. New Formulation of Oritavancin: New formulation of oritavancin (1 hour infusion of 1200 mg in 250 ml of saline)	Total n=102 Participants Total of all reporting groups
Age, Continuous	46.4 years STANDARD_DEVIATION 12.1 • n=5 Participants	42.1 years STANDARD_DEVIATION 12.7 • n=7 Participants	44.3 years STANDARD_DEVIATION 12.6 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	20 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	30 Participants n=7 Participants	67 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	21 Participants n=5 Participants	21 Participants n=7 Participants	42 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=5 Participants	29 Participants n=7 Participants	60 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	2 Participants n=5 Participants	1 Participants n=7 Participants	3 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	45 Participants n=5 Participants	46 Participants n=7 Participants	91 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	52 participants n=5 Participants	50 participants n=7 Participants	102 participants n=5 Participants
Body Mass Index (BMI)	27.3 kg/m2 STANDARD_DEVIATION 6 • n=5 Participants	29.7 kg/m2 STANDARD_DEVIATION 8.5 • n=7 Participants	28.5 kg/m2 STANDARD_DEVIATION 7.4 • n=5 Participants
Weight	80.8 kg STANDARD_DEVIATION 19.5 • n=5 Participants	88.7 kg STANDARD_DEVIATION 26.9 • n=7 Participants	84.7 kg STANDARD_DEVIATION 23.7 • n=5 Participants

PRIMARY outcome

Timeframe: 72 hours

Population: PK Population: all subjects who have received the full dose of oritavancin and have any valid samples measured for study drug levels

Relative exposure of AUC of the new formulation to the approved formulation of oritavancin based on area under the plasma concentration-time curve from time zero to 72 hr (AUC0-72)

Outcome measures

Measure	Orbactiv n=50 Participants Three single-use vials, each containing 400 mg (1200 mg total) of oritavancin diphosphate (as the free base) and the inactive component mannitol. Orbactiv vials were reconstituted with SWFI and further diluted in D5W for a total volume of 1000 mL and infused intravenously over 3 hours.	Kimrysa n=50 Participants A single vial containing 1200 mg of oritavancin, HPβCD, and mannitol. Kimrysa vial was reconstituted with SWFI and further diluted with 0.9% sodium chloride for a total volume of 250 mL and infused intravenously over 1 hour.
Relative Exposure of AUC of the New Formulation to the Approved Formulation	1470 h*µg/mL Geometric Coefficient of Variation 39.7	1460 h*µg/mL Geometric Coefficient of Variation 35.1

PRIMARY outcome

Timeframe: 168 hours (Day 8)

Population: PK Population

Relative exposure of AUC of the new formulation to the approved formulation of oritavancin based on area under the plasma concentration-time curve from time zero to 168 hr (AUC0-168).

Outcome measures

Measure	Orbactiv n=50 Participants Three single-use vials, each containing 400 mg (1200 mg total) of oritavancin diphosphate (as the free base) and the inactive component mannitol. Orbactiv vials were reconstituted with SWFI and further diluted in D5W for a total volume of 1000 mL and infused intravenously over 3 hours.	Kimrysa n=50 Participants A single vial containing 1200 mg of oritavancin, HPβCD, and mannitol. Kimrysa vial was reconstituted with SWFI and further diluted with 0.9% sodium chloride for a total volume of 250 mL and infused intravenously over 1 hour.
Relative Exposure of AUC of the New Formulation to the Approved Formulation	1760 h*µg/mL Geometric Coefficient of Variation 41.4	1750 h*µg/mL Geometric Coefficient of Variation 35

SECONDARY outcome

Timeframe: 336 hours (Day 15)

Population: Safety analysis

Number of subjects with at least one treatment emergent adverse event (TEAE)

Outcome measures

Measure	Orbactiv n=52 Participants Three single-use vials, each containing 400 mg (1200 mg total) of oritavancin diphosphate (as the free base) and the inactive component mannitol. Orbactiv vials were reconstituted with SWFI and further diluted in D5W for a total volume of 1000 mL and infused intravenously over 3 hours.	Kimrysa n=50 Participants A single vial containing 1200 mg of oritavancin, HPβCD, and mannitol. Kimrysa vial was reconstituted with SWFI and further diluted with 0.9% sodium chloride for a total volume of 250 mL and infused intravenously over 1 hour.
Number of Subjects With at Least One Treatment Emergent Adverse Event (TEAE)	31 Participants	24 Participants

Adverse Events

Orbactiv

Serious events: 1 serious events

Other events: 31 other events

Deaths: 0 deaths

Kimrysa

Serious events: 2 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Measure	Orbactiv n=52 participants at risk Three single-use vials, each containing 400 mg (1200 mg total) of oritavancin diphosphate (as the free base) and the inactive component mannitol. Orbactiv vials were reconstituted with SWFI and further diluted in D5W for a total volume of 1000 mL and infused intravenously over 3 hours.	Kimrysa n=50 participants at risk A single vial containing 1200 mg of oritavancin, HPβCD, and mannitol. Kimrysa vial was reconstituted with SWFI and further diluted with 0.9% sodium chloride for a total volume of 250 mL and infused intravenously over 1 hour.
Infections and infestations worsening of left leg cellulitis	1.9% 1/52 • Number of events 1 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.	2.0% 1/50 • Number of events 1 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.
Infections and infestations Pyelonephritis	0.00% 0/52 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.	2.0% 1/50 • Number of events 1 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.

Other adverse events

Measure	Orbactiv n=52 participants at risk Three single-use vials, each containing 400 mg (1200 mg total) of oritavancin diphosphate (as the free base) and the inactive component mannitol. Orbactiv vials were reconstituted with SWFI and further diluted in D5W for a total volume of 1000 mL and infused intravenously over 3 hours.	Kimrysa n=50 participants at risk A single vial containing 1200 mg of oritavancin, HPβCD, and mannitol. Kimrysa vial was reconstituted with SWFI and further diluted with 0.9% sodium chloride for a total volume of 250 mL and infused intravenously over 1 hour.
Injury, poisoning and procedural complications concussion	1.9% 1/52 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.	0.00% 0/50 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.
Injury, poisoning and procedural complications contusion	1.9% 1/52 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.	0.00% 0/50 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.
Injury, poisoning and procedural complications overdose	1.9% 1/52 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.	0.00% 0/50 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.
Injury, poisoning and procedural complications road traffic accident	1.9% 1/52 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.	0.00% 0/50 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.
Injury, poisoning and procedural complications skin abrasion	1.9% 1/52 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.	0.00% 0/50 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.
Injury, poisoning and procedural complications skin laceration	1.9% 1/52 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.	0.00% 0/50 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.
Injury, poisoning and procedural complications upper limb fracture	1.9% 1/52 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.	0.00% 0/50 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.
Investigations alanine aminotransferase increased	1.9% 1/52 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.	0.00% 0/50 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.
Infections and infestations Vulvovaginal mycotic infection	1.9% 1/52 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.	0.00% 0/50 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.
Immune system disorders Hypersensitivity	3.8% 2/52 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.	2.0% 1/50 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.
Infections and infestations Abscess	1.9% 1/52 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.	0.00% 0/50 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.
Infections and infestations Infection	5.8% 3/52 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.	4.0% 2/50 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.
Infections and infestations Oral candidiasis	0.00% 0/52 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.	2.0% 1/50 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.
Infections and infestations Skin infection	3.8% 2/52 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.	0.00% 0/50 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.
Infections and infestations Urinary tract infection	1.9% 1/52 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.	0.00% 0/50 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.
Investigations aspartate aminotransferase increased	1.9% 1/52 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.	0.00% 0/50 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.
Investigations heart rate increased	0.00% 0/52 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.	2.0% 1/50 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.
Musculoskeletal and connective tissue disorders arthralgia	1.9% 1/52 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.	0.00% 0/50 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.
Musculoskeletal and connective tissue disorders back pain	1.9% 1/52 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.	0.00% 0/50 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.
Musculoskeletal and connective tissue disorders muscle twitching	1.9% 1/52 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.	0.00% 0/50 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.
Musculoskeletal and connective tissue disorders pain in extremity	0.00% 0/52 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.	2.0% 1/50 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.
Nervous system disorders headache	0.00% 0/52 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.	4.0% 2/50 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.
Nervous system disorders presyncope	0.00% 0/52 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.	2.0% 1/50 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.
Gastrointestinal disorders abdominal pain	0.00% 0/52 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.	2.0% 1/50 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.
Gastrointestinal disorders diarrhoea	9.6% 5/52 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.	6.0% 3/50 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.
Gastrointestinal disorders nausea	5.8% 3/52 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.	2.0% 1/50 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.
Gastrointestinal disorders toothache	0.00% 0/52 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.	2.0% 1/50 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.
Gastrointestinal disorders vomiting	3.8% 2/52 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.	0.00% 0/50 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.
General disorders chills	1.9% 1/52 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.	6.0% 3/50 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.
General disorders drug withdrawal syndrome	1.9% 1/52 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.	0.00% 0/50 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.
General disorders infusion site extravasation	1.9% 1/52 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.	2.0% 1/50 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.
General disorders pyrexia	1.9% 1/52 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.	6.0% 3/50 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.
General disorders infusion site pain	0.00% 0/52 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.	2.0% 1/50 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.
General disorders infusion site swelling	1.9% 1/52 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.	0.00% 0/50 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.
General disorders oedema	1.9% 1/52 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.	0.00% 0/50 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.
General disorders oedema peripheral	0.00% 0/52 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.	2.0% 1/50 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.
General disorders peripheral swelling	1.9% 1/52 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.	0.00% 0/50 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.
Renal and urinary disorders dysuria	0.00% 0/52 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.	2.0% 1/50 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.
Reproductive system and breast disorders scrotal oedema	0.00% 0/52 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.	2.0% 1/50 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.
Skin and subcutaneous tissue disorders pruritus	13.5% 7/52 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.	4.0% 2/50 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.
Skin and subcutaneous tissue disorders pruritus generalised	5.8% 3/52 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.	6.0% 3/50 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.
Skin and subcutaneous tissue disorders red man syndrome	0.00% 0/52 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.	2.0% 1/50 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.
Skin and subcutaneous tissue disorders urticaria	1.9% 1/52 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.	0.00% 0/50 • From the time of study drug initiation to Day 15 Adverse events and serious adverse events will be assessed from the time of study drug administration through Day 15 post administration of oritavancin. AEs will be collected at every subject visit.

Additional Information

Vice President Clinical Operations

Melinta Therapeutics, Inc.

Phone: 9086171319

Email: kfusaro@melinta.com

Results disclosure agreements

• Principal investigator is a sponsor employee No such presentation or publication will be initiated by PI until earliest to occur of the following (i) 12 months after the conclusion of the study (ii) publication by the Sponsor or the lead investigator or (iii) written approval is obtained by the Sponsor. PI will provide Sponsor with a draft of any proposed presentation or publication for review at least 45 days in advance of the submission, presentation or publication date.
• Publication restrictions are in place

Restriction type: OTHER