Trial Outcomes & Findings for Safety and Pharmacokinetics of Rezafungin (NCT NCT04117607)
NCT ID: NCT04117607
Last Updated: 2021-07-16
Results Overview
Each subject is only counted once per toxicity grade for the worst severity recorded. Vital sign parameters include systolic blood pressure (BP), diastolic BP, heart rate, respiratory rate, and temperature. Thresholds for abnormal vital signs were considered as systolic BP \>= 141 mmHg or \<= 89 mmHg, diastolic BP \>= 91 mmHg, heart rate \<= 54 bpm (baseline \>= 60 bpm) or \<=50 (baseline \< 60 bpm) or \>= 101 bpm, respiratory rate \>= 23 breaths per minute, and temperature \>= 38.0 degrees Celsius. If a vital sign result met the threshold for an AE at baseline, subsequent vital sign results were only considered to be an AE if the grading worsened in severity.
TERMINATED
PHASE1
14 participants
Day 1, 1 hour post-dose
2021-07-16
Participant Flow
Participants included healthy male and females aged 18-45 years (inclusive). Participants were recruited from the local community to ensure that male, female, and minorities (African American, Native American, Asian, and Hispanics) were represented in the enrolled population. Participants were enrolled between 04DEC2019 and 11MAR2020.
Participant milestones
| Measure |
SAD1
1 mg (1 injection of 0.1 mL diluted 1:10 in 5% Dextrose Injection, USP) of Rezafungin administered subcutaneously into the abdomen as a single dose, on Day 1 in a double-blind manner.
Rezafungin: Rezafungin, 100 mg/mL, is a sterile liquid product supplied in single-dose vials containing 1.0 mL of extractable volume. The active pharmaceutical ingredient is rezafungin acetate, a water-soluble amorphous acetate salt. The inactive ingredient is mannitol.
|
SAD2
10 mg (1 injection of 0.1 mL) of Rezafungin administered subcutaneously into the abdomen as a single dose, on Day 1 in a double-blind manner.
Rezafungin: Rezafungin, 100 mg/mL, is a sterile liquid product supplied in single-dose vials containing 1.0 mL of extractable volume. The active pharmaceutical ingredient is rezafungin acetate, a water-soluble amorphous acetate salt. The inactive ingredient is mannitol.
|
SAD3
30 mg (1 injection of 0.3 mL) of Rezafungin administered subcutaneously into the abdomen as a single dose, on Day 1 in a double-blind manner.
Rezafungin: Rezafungin, 100 mg/mL, is a sterile liquid product supplied in single-dose vials containing 1.0 mL of extractable volume. The active pharmaceutical ingredient is rezafungin acetate, a water-soluble amorphous acetate salt. The inactive ingredient is mannitol.
|
SAD4
60 mg (1 injection of 0.6 mL) of Rezafungin administered subcutaneously into the abdomen as a single dose, on Day 1 in a double-blind manner.
Rezafungin: Rezafungin, 100 mg/mL, is a sterile liquid product supplied in single-dose vials containing 1.0 mL of extractable volume. The active pharmaceutical ingredient is rezafungin acetate, a water-soluble amorphous acetate salt. The inactive ingredient is mannitol.
|
SAD5
100 mg (1 injection of 1.0 mL) of Rezafungin administered subcutaneously as a single dose, on Day 1 in a double-blind manner.
Rezafungin: Rezafungin, 100 mg/mL, is a sterile liquid product supplied in single-dose vials containing 1.0 mL of extractable volume. The active pharmaceutical ingredient is rezafungin acetate, a water-soluble amorphous acetate salt. The inactive ingredient is mannitol.
|
SAD6
200 mg (2 injections of 1.0 mL) of Rezafungin administered subcutaneously into the same abdominal quadrant (separated by approximately 5 cm) as a single dose, on Day 1 in a double-blind manner.
Rezafungin: Rezafungin, 100 mg/mL, is a sterile liquid product supplied in single-dose vials containing 1.0 mL of extractable volume. The active pharmaceutical ingredient is rezafungin acetate, a water-soluble amorphous acetate salt. The inactive ingredient is mannitol.
|
SAD Placebo
Placebo participants across all SAD cohorts: 1 mg (1 injection of 0.1 mL diluted 1:10 in 5% Dextrose Injection, USP), 10 mg (1 injection of 0.1 ml), 30 mg (1 injection of 0.3 ml), 60 mg (1 injection of 0.6 ml), 100 mg (1 injection of 1 ml), or 200 mg (2 injections of 1 ml) of matching placebo administered subcutaneously as a single dose in a double-blind manner on Day 1 in a double-blind manner.
The 200 mg dose injections will be administered in the same abdominal quadrant, separated by approximately 5 cm.
Placebo: 5% Dextrose Injection, USP, a sterile, nonpyrogenic solution of dextrose in water for injection. The solution has the osmolarity of 252 mOsmol/L, which is slightly hypotonic. This solution contains no bacteriostat, antimicrobial agent or added buffer.
|
MAD1
30 mg (1 injection of 0.3 mL) of Rezafungin administered subcutaneously into the abdomen as three doses, with each dose administered in a different quadrant (3 quadrants total), on Days 1, 8, and 15 in a double-blind manner.
Rezafungin: Rezafungin, 100 mg/mL, is a sterile liquid product supplied in single-dose vials containing 1.0 mL of extractable volume. The active pharmaceutical ingredient is rezafungin acetate, a water-soluble amorphous acetate salt. The inactive ingredient is mannitol.
|
MAD2
60 mg (1 injection of 0.6 mL) of Rezafungin administered subcutaneously into the abdomen as three doses, with each dose administered in a different quadrant (3 quadrants total), on Days 1, 8, and 15 in a double-blind manner.
Rezafungin: Rezafungin, 100 mg/mL, is a sterile liquid product supplied in single-dose vials containing 1.0 mL of extractable volume. The active pharmaceutical ingredient is rezafungin acetate, a water-soluble amorphous acetate salt. The inactive ingredient is mannitol.
|
MAD3
100 mg (1 injection of 1.0 mL) of Rezafungin administered subcutaneously into the abdomen as as three doses, with each dose administered in a different quadrant (3 quadrants total), on Days 1, 8, and 15 in a double-blind manner.
Rezafungin: Rezafungin, 100 mg/mL, is a sterile liquid product supplied in single-dose vials containing 1.0 mL of extractable volume. The active pharmaceutical ingredient is rezafungin acetate, a water-soluble amorphous acetate salt. The inactive ingredient is mannitol.
|
MAD4
200 mg (2 injections of 1.0 mL) of Rezafungin administered subcutaneously into the abdomen as three doses, each injection will be administered in the same quadrant (separated by approximately 5 cm) and each separate dose will be administered into different abdominal quadrants (3 quadrants total), on Days 1, 8, and 15 in a double-blind manner.
Rezafungin: Rezafungin, 100 mg/mL, is a sterile liquid product supplied in single-dose vials containing 1.0 mL of extractable volume. The active pharmaceutical ingredient is rezafungin acetate, a water-soluble amorphous acetate salt. The inactive ingredient is mannitol.
|
MAD Placebo
Placebo participants across all MAD cohorts: 30 mg (1 injection of 0.3 mL), 60 mg (1 injection of 0.6 ml), 100 mg (1 injection of 1.0 ml), 200 mg (2 injections of 1.0 ml), of matching placebo administered subcutaneously as three doses on Days 1, 8, and 15 in a double-blind manner. The 200 mg dose injections will be administered in the same abdominal quadrant, separated by approximately 5 cm. Each dose will be administered in a different quadrant (3 quadrants total).
Placebo: 5% Dextrose Injection, USP, a sterile, nonpyrogenic solution of dextrose in water for injection. The solution has the osmolarity of 252 mOsmol/L, which is slightly hypotonic. This solution contains no bacteriostat, antimicrobial agent or added buffer.
|
BA 1
100 mg (1 injection of 1.0 mL) or maximum tolerated dose (MTD) of Rezafungin, determined in part 1 of the study (SAD), administered subcutaneously into the abdomen on Day 1, and 100 mg (250 mL) or MTD of Rezafungin administered via intravenous infusion over 60 minutes on Day 22 in an open label manner.
Rezafungin for subcutaneous use: Rezafungin, 100 mg/mL, is a sterile liquid product supplied in single-dose vials containing 1.0 mL of extractable volume. The active pharmaceutical ingredient is rezafungin acetate, a water-soluble amorphous acetate salt. The inactive ingredient is mannitol.
Rezafungin for intravenous infusion: Rezafungin, 200 mg/vial, is a sterile product supplied as a white to pale yellow lyophilized powder in single-dose glass vials for reconstitution with Sterile Water for Injection, United States Pharmacopeia (USP). The reconstituted product is diluted in 0.9% Sodium Chloride Injection, USP for IV infusion. The active pharmaceutical ingredient is rezafungin acetate, a water-soluble amorphous acetate salt. The inactive ingredients include excipients of mannitol, polysorbate 80, and histidine.
|
BA 2
100 mg (250 mL) or maximum tolerated dose (MTD) of Rezafungin, determined in part 1 of the study (SAD), administered via intravenous infusion over 60 minutes on Day 1, and 100 mg (1 injection of 1.0 mL) or MTD of Rezafungin administered subcutaneously into the abdomen on Day 22 in an open label manner.
Rezafungin for subcutaneous use: Rezafungin, 100 mg/mL, is a sterile liquid product supplied in single-dose vials containing 1.0 mL of extractable volume. The active pharmaceutical ingredient is rezafungin acetate, a water-soluble amorphous acetate salt. The inactive ingredient is mannitol.
Rezafungin for intravenous infusion: Rezafungin, 200 mg/vial, is a sterile product supplied as a white to pale yellow lyophilized powder in single-dose glass vials for reconstitution with Sterile Water for Injection, United States Pharmacopeia (USP). The reconstituted product is diluted in 0.9% Sodium Chloride Injection, USP for IV infusion. The active pharmaceutical ingredient is rezafungin acetate, a water-soluble amorphous acetate salt. The inactive ingredients include excipients of mannitol, polysorbate 80, and histidine.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
7
|
0
|
0
|
0
|
0
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Received Study Product
|
3
|
6
|
0
|
0
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Completed All PK Blood Draws
|
0
|
6
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
3
|
6
|
0
|
0
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
SAD1
1 mg (1 injection of 0.1 mL diluted 1:10 in 5% Dextrose Injection, USP) of Rezafungin administered subcutaneously into the abdomen as a single dose, on Day 1 in a double-blind manner.
Rezafungin: Rezafungin, 100 mg/mL, is a sterile liquid product supplied in single-dose vials containing 1.0 mL of extractable volume. The active pharmaceutical ingredient is rezafungin acetate, a water-soluble amorphous acetate salt. The inactive ingredient is mannitol.
|
SAD2
10 mg (1 injection of 0.1 mL) of Rezafungin administered subcutaneously into the abdomen as a single dose, on Day 1 in a double-blind manner.
Rezafungin: Rezafungin, 100 mg/mL, is a sterile liquid product supplied in single-dose vials containing 1.0 mL of extractable volume. The active pharmaceutical ingredient is rezafungin acetate, a water-soluble amorphous acetate salt. The inactive ingredient is mannitol.
|
SAD3
30 mg (1 injection of 0.3 mL) of Rezafungin administered subcutaneously into the abdomen as a single dose, on Day 1 in a double-blind manner.
Rezafungin: Rezafungin, 100 mg/mL, is a sterile liquid product supplied in single-dose vials containing 1.0 mL of extractable volume. The active pharmaceutical ingredient is rezafungin acetate, a water-soluble amorphous acetate salt. The inactive ingredient is mannitol.
|
SAD4
60 mg (1 injection of 0.6 mL) of Rezafungin administered subcutaneously into the abdomen as a single dose, on Day 1 in a double-blind manner.
Rezafungin: Rezafungin, 100 mg/mL, is a sterile liquid product supplied in single-dose vials containing 1.0 mL of extractable volume. The active pharmaceutical ingredient is rezafungin acetate, a water-soluble amorphous acetate salt. The inactive ingredient is mannitol.
|
SAD5
100 mg (1 injection of 1.0 mL) of Rezafungin administered subcutaneously as a single dose, on Day 1 in a double-blind manner.
Rezafungin: Rezafungin, 100 mg/mL, is a sterile liquid product supplied in single-dose vials containing 1.0 mL of extractable volume. The active pharmaceutical ingredient is rezafungin acetate, a water-soluble amorphous acetate salt. The inactive ingredient is mannitol.
|
SAD6
200 mg (2 injections of 1.0 mL) of Rezafungin administered subcutaneously into the same abdominal quadrant (separated by approximately 5 cm) as a single dose, on Day 1 in a double-blind manner.
Rezafungin: Rezafungin, 100 mg/mL, is a sterile liquid product supplied in single-dose vials containing 1.0 mL of extractable volume. The active pharmaceutical ingredient is rezafungin acetate, a water-soluble amorphous acetate salt. The inactive ingredient is mannitol.
|
SAD Placebo
Placebo participants across all SAD cohorts: 1 mg (1 injection of 0.1 mL diluted 1:10 in 5% Dextrose Injection, USP), 10 mg (1 injection of 0.1 ml), 30 mg (1 injection of 0.3 ml), 60 mg (1 injection of 0.6 ml), 100 mg (1 injection of 1 ml), or 200 mg (2 injections of 1 ml) of matching placebo administered subcutaneously as a single dose in a double-blind manner on Day 1 in a double-blind manner.
The 200 mg dose injections will be administered in the same abdominal quadrant, separated by approximately 5 cm.
Placebo: 5% Dextrose Injection, USP, a sterile, nonpyrogenic solution of dextrose in water for injection. The solution has the osmolarity of 252 mOsmol/L, which is slightly hypotonic. This solution contains no bacteriostat, antimicrobial agent or added buffer.
|
MAD1
30 mg (1 injection of 0.3 mL) of Rezafungin administered subcutaneously into the abdomen as three doses, with each dose administered in a different quadrant (3 quadrants total), on Days 1, 8, and 15 in a double-blind manner.
Rezafungin: Rezafungin, 100 mg/mL, is a sterile liquid product supplied in single-dose vials containing 1.0 mL of extractable volume. The active pharmaceutical ingredient is rezafungin acetate, a water-soluble amorphous acetate salt. The inactive ingredient is mannitol.
|
MAD2
60 mg (1 injection of 0.6 mL) of Rezafungin administered subcutaneously into the abdomen as three doses, with each dose administered in a different quadrant (3 quadrants total), on Days 1, 8, and 15 in a double-blind manner.
Rezafungin: Rezafungin, 100 mg/mL, is a sterile liquid product supplied in single-dose vials containing 1.0 mL of extractable volume. The active pharmaceutical ingredient is rezafungin acetate, a water-soluble amorphous acetate salt. The inactive ingredient is mannitol.
|
MAD3
100 mg (1 injection of 1.0 mL) of Rezafungin administered subcutaneously into the abdomen as as three doses, with each dose administered in a different quadrant (3 quadrants total), on Days 1, 8, and 15 in a double-blind manner.
Rezafungin: Rezafungin, 100 mg/mL, is a sterile liquid product supplied in single-dose vials containing 1.0 mL of extractable volume. The active pharmaceutical ingredient is rezafungin acetate, a water-soluble amorphous acetate salt. The inactive ingredient is mannitol.
|
MAD4
200 mg (2 injections of 1.0 mL) of Rezafungin administered subcutaneously into the abdomen as three doses, each injection will be administered in the same quadrant (separated by approximately 5 cm) and each separate dose will be administered into different abdominal quadrants (3 quadrants total), on Days 1, 8, and 15 in a double-blind manner.
Rezafungin: Rezafungin, 100 mg/mL, is a sterile liquid product supplied in single-dose vials containing 1.0 mL of extractable volume. The active pharmaceutical ingredient is rezafungin acetate, a water-soluble amorphous acetate salt. The inactive ingredient is mannitol.
|
MAD Placebo
Placebo participants across all MAD cohorts: 30 mg (1 injection of 0.3 mL), 60 mg (1 injection of 0.6 ml), 100 mg (1 injection of 1.0 ml), 200 mg (2 injections of 1.0 ml), of matching placebo administered subcutaneously as three doses on Days 1, 8, and 15 in a double-blind manner. The 200 mg dose injections will be administered in the same abdominal quadrant, separated by approximately 5 cm. Each dose will be administered in a different quadrant (3 quadrants total).
Placebo: 5% Dextrose Injection, USP, a sterile, nonpyrogenic solution of dextrose in water for injection. The solution has the osmolarity of 252 mOsmol/L, which is slightly hypotonic. This solution contains no bacteriostat, antimicrobial agent or added buffer.
|
BA 1
100 mg (1 injection of 1.0 mL) or maximum tolerated dose (MTD) of Rezafungin, determined in part 1 of the study (SAD), administered subcutaneously into the abdomen on Day 1, and 100 mg (250 mL) or MTD of Rezafungin administered via intravenous infusion over 60 minutes on Day 22 in an open label manner.
Rezafungin for subcutaneous use: Rezafungin, 100 mg/mL, is a sterile liquid product supplied in single-dose vials containing 1.0 mL of extractable volume. The active pharmaceutical ingredient is rezafungin acetate, a water-soluble amorphous acetate salt. The inactive ingredient is mannitol.
Rezafungin for intravenous infusion: Rezafungin, 200 mg/vial, is a sterile product supplied as a white to pale yellow lyophilized powder in single-dose glass vials for reconstitution with Sterile Water for Injection, United States Pharmacopeia (USP). The reconstituted product is diluted in 0.9% Sodium Chloride Injection, USP for IV infusion. The active pharmaceutical ingredient is rezafungin acetate, a water-soluble amorphous acetate salt. The inactive ingredients include excipients of mannitol, polysorbate 80, and histidine.
|
BA 2
100 mg (250 mL) or maximum tolerated dose (MTD) of Rezafungin, determined in part 1 of the study (SAD), administered via intravenous infusion over 60 minutes on Day 1, and 100 mg (1 injection of 1.0 mL) or MTD of Rezafungin administered subcutaneously into the abdomen on Day 22 in an open label manner.
Rezafungin for subcutaneous use: Rezafungin, 100 mg/mL, is a sterile liquid product supplied in single-dose vials containing 1.0 mL of extractable volume. The active pharmaceutical ingredient is rezafungin acetate, a water-soluble amorphous acetate salt. The inactive ingredient is mannitol.
Rezafungin for intravenous infusion: Rezafungin, 200 mg/vial, is a sterile product supplied as a white to pale yellow lyophilized powder in single-dose glass vials for reconstitution with Sterile Water for Injection, United States Pharmacopeia (USP). The reconstituted product is diluted in 0.9% Sodium Chloride Injection, USP for IV infusion. The active pharmaceutical ingredient is rezafungin acetate, a water-soluble amorphous acetate salt. The inactive ingredients include excipients of mannitol, polysorbate 80, and histidine.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Early Termination
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety and Pharmacokinetics of Rezafungin
Baseline characteristics by cohort
| Measure |
SAD1
n=3 Participants
1 mg (1 injection of 0.1 mL diluted 1:10 in 5% Dextrose Injection, USP) of Rezafungin administered subcutaneously.
|
SAD2
n=7 Participants
10 mg (1 injection of 0.1 mL) of Rezafungin administered subcutaneously.
|
SAD Placebo
n=4 Participants
Placebo participants across all SAD cohorts given matching placebo administered subcutaneously as a single dose in a double-blind manner.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Height (cm)
|
174.73 cm
STANDARD_DEVIATION 8.84 • n=5 Participants
|
177.74 cm
STANDARD_DEVIATION 5.77 • n=7 Participants
|
172.1 cm
STANDARD_DEVIATION 6.15 • n=5 Participants
|
175.49 cm
STANDARD_DEVIATION 6.52 • n=4 Participants
|
|
Age, Continuous
|
33.7 years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
33.6 years
STANDARD_DEVIATION 6.5 • n=7 Participants
|
33.8 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
33.6 years
STANDARD_DEVIATION 5.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Weight (kg)
|
85.9 kg
STANDARD_DEVIATION 13.75 • n=5 Participants
|
88.13 kg
STANDARD_DEVIATION 17 • n=7 Participants
|
77.23 kg
STANDARD_DEVIATION 18.67 • n=5 Participants
|
84.54 kg
STANDARD_DEVIATION 16.33 • n=4 Participants
|
|
BMI (kg/m^2)
|
27.97 kg/m^2
STANDARD_DEVIATION 1.72 • n=5 Participants
|
27.74 kg/m^2
STANDARD_DEVIATION 4.18 • n=7 Participants
|
25.85 kg/m^2
STANDARD_DEVIATION 4.23 • n=5 Participants
|
27.25 kg/m^2
STANDARD_DEVIATION 3.67 • n=4 Participants
|
PRIMARY outcome
Timeframe: Day 2Population: Safety population: All participants that received any amount of study product.
Laboratory parameters and associated thresholds include albumin \<=3.4 g/dL, glucose \<= 69 mg/dL or \>=106 mg/dL, blood urea nitrogen (BUN) \>= 21 mg/dL, potassium \>=5.2 mEq/L or \<=3.4 mEq/L, calcium \< 8.7 mg/dL or \>=10.3 mg/dL, sodium \<=132 mEq/L or \>=144 mEq/L, total protein \<=5.9 g/dL, creatinine \>=1.3 mg/dL (male) or \>= 1.0 mg/dL (female), creatine phosphokinase \>= 309 U/L, phosphorus \<=2.4 mg/dL, alkaline phosphatase \>= 131 IU/L (males) or \>= 106 IU/L (female), aspartate aminotransferase \>= 40 U/L (male) or \>= 32 U/L (female), alanine aminotransferase \>=41 U/L (male) or \>= 33 U/L (female), and total bilirubin \>=106 mg/dL. If a clinical chemistry laboratory value met the threshold for an AE at baseline, subsequent safety laboratory results were only considered to be an AE if the grading worsened in severity.
Outcome measures
| Measure |
SAD1
n=3 Participants
1 mg (1 injection of 0.1 mL diluted 1:10 in 5% Dextrose Injection, USP) of Rezafungin administered subcutaneously.
|
SAD2
n=6 Participants
10 mg (1 injection of 0.1 mL) of Rezafungin administered subcutaneously.
|
SAD Placebo
n=3 Participants
Placebo participants across all SAD cohorts given matching placebo administered subcutaneously as a single dose in a double-blind manner.
|
MAD4
200 mg (2 injections of 1.0 mL) of Rezafungin administered subcutaneously.
|
MAD Placebo
Placebo participants across all MAD cohorts given matching placebo administered subcutaneously.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Chemistry Laboratory Toxicity Results for Single Ascending Dose (SAD) on Day 2
Any Parameter
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Chemistry Laboratory Toxicity Results for Single Ascending Dose (SAD) on Day 2
Alanine Aminotransferase, Increase
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Chemistry Laboratory Toxicity Results for Single Ascending Dose (SAD) on Day 2
Glucose, Increase
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 7Population: Safety population: All participants that received any amount of study product.
Laboratory parameters and associated thresholds include albumin \<=3.4 g/dL, glucose \<= 69 mg/dL or \>=106 mg/dL, blood urea nitrogen (BUN) \>= 21 mg/dL, potassium \>=5.2 mEq/L or \<=3.4 mEq/L, calcium \< 8.7 mg/dL or \>=10.3 mg/dL, sodium \<=132 mEq/L or \>=144 mEq/L, total protein \<=5.9 g/dL, creatinine \>=1.3 mg/dL (male) or \>= 1.0 mg/dL (female), creatine phosphokinase \>= 309 U/L, phosphorus \<=2.4 mg/dL, alkaline phosphatase \>= 131 IU/L (males) or \>= 106 IU/L (female), aspartate aminotransferase \>= 40 U/L (male) or \>= 32 U/L (female), alanine aminotransferase \>=41 U/L (male) or \>= 33 U/L (female), and total bilirubin \>=106 mg/dL. If a clinical chemistry laboratory value met the threshold for an AE at baseline, subsequent safety laboratory results were only considered to be an AE if the grading worsened in severity.
Outcome measures
| Measure |
SAD1
n=3 Participants
1 mg (1 injection of 0.1 mL diluted 1:10 in 5% Dextrose Injection, USP) of Rezafungin administered subcutaneously.
|
SAD2
n=6 Participants
10 mg (1 injection of 0.1 mL) of Rezafungin administered subcutaneously.
|
SAD Placebo
n=3 Participants
Placebo participants across all SAD cohorts given matching placebo administered subcutaneously as a single dose in a double-blind manner.
|
MAD4
200 mg (2 injections of 1.0 mL) of Rezafungin administered subcutaneously.
|
MAD Placebo
Placebo participants across all MAD cohorts given matching placebo administered subcutaneously.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Chemistry Laboratory Toxicity Results for Single Ascending Dose (SAD) on Day 7
Any Parameter
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Chemistry Laboratory Toxicity Results for Single Ascending Dose (SAD) on Day 7
Potassium, Increase
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Chemistry Laboratory Toxicity Results for Single Ascending Dose (SAD) on Day 7
Calcium, Increase
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Chemistry Laboratory Toxicity Results for Single Ascending Dose (SAD) on Day 7
Alanine Aminotransferase, Increase
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 30Population: Safety population: All participants that received any amount of study product.
Laboratory parameters and associated thresholds include albumin \<=3.4 g/dL, glucose \<= 69 mg/dL or \>=106 mg/dL, blood urea nitrogen (BUN) \>= 21 mg/dL, potassium \>=5.2 mEq/L or \<=3.4 mEq/L, calcium \< 8.7 mg/dL or \>=10.3 mg/dL, sodium \<=132 mEq/L or \>=144 mEq/L, total protein \<=5.9 g/dL, creatinine \>=1.3 mg/dL (male) or \>= 1.0 mg/dL (female), creatine phosphokinase \>= 309 U/L, phosphorus \<=2.4 mg/dL, alkaline phosphatase \>= 131 IU/L (males) or \>= 106 IU/L (female), aspartate aminotransferase \>= 40 U/L (male) or \>= 32 U/L (female), alanine aminotransferase \>=41 U/L (male) or \>= 33 U/L (female), and total bilirubin \>=106 mg/dL. If a clinical chemistry laboratory value met the threshold for an AE at baseline, subsequent safety laboratory results were only considered to be an AE if the grading worsened in severity.
Outcome measures
| Measure |
SAD1
n=3 Participants
1 mg (1 injection of 0.1 mL diluted 1:10 in 5% Dextrose Injection, USP) of Rezafungin administered subcutaneously.
|
SAD2
n=6 Participants
10 mg (1 injection of 0.1 mL) of Rezafungin administered subcutaneously.
|
SAD Placebo
n=3 Participants
Placebo participants across all SAD cohorts given matching placebo administered subcutaneously as a single dose in a double-blind manner.
|
MAD4
200 mg (2 injections of 1.0 mL) of Rezafungin administered subcutaneously.
|
MAD Placebo
Placebo participants across all MAD cohorts given matching placebo administered subcutaneously.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Chemistry Laboratory Toxicity Results for Single Ascending Dose (SAD) on Day 30
Any Parameter
|
0 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Chemistry Laboratory Toxicity Results for Single Ascending Dose (SAD) on Day 30
Alanine Aminotransferase, Increase
|
0 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 2 through Day 45Population: The study was terminated on 27APR2020 due to safety concerns. No subjects were enrolled into these groups.
Laboratory parameters and associated thresholds include albumin \<=3.4 g/dL, glucose \<= 69 mg/dL or \>=106 mg/dL, blood urea nitrogen (BUN) \>= 21 mg/dL, potassium \>=5.2 mEq/L or \<=3.4 mEq/L, calcium \< 8.7 mg/dL or \>=10.3 mg/dL, sodium \<=132 mEq/L or \>=144 mEq/L, total protein \<=5.9 g/dL, creatinine \>=1.3 mg/dL (male) or \>= 1.0 mg/dL (female), creatine phosphokinase \>= 309 U/L, phosphorus \<=2.4 mg/dL, alkaline phosphatase \>= 131 IU/L (males) or \>= 106 IU/L (female), aspartate aminotransferase \>= 40 U/L (male) or \>= 32 U/L (female), alanine aminotransferase \>=41 U/L (male) or \>= 33 U/L (female), and total bilirubin \>=106 mg/dL. If a clinical chemistry laboratory value met the threshold for an AE at baseline, subsequent safety laboratory results were only considered to be an AE if the grading worsened in severity.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 2Population: Safety population: All participants that received any amount of study product.
Laboratory parameters and associated thresholds for adverse events include hemoglobin \<= 12.2 g/dL (male) or \<= 10.8 g/dL (female), hematocrit \<= 36.1 % (male) or \<= 32.6 % (female), red blood cell (RBC) count \<= 4.1 x 10\^6/uL (male) or \<= 3.7 x 10\^6/uL (female), white blood cell (WBC) count \>= 9,001 cell/mm3 or \<= 2,499 cell/mm3 (African American Males) or \>= 11,001 cell/mm3 or \<= 2,499 cell/mm3 (African American Females) or \>= 10,001 cell/mm3 or \<= 3,999 cell/mm3 (all others), neutrophil count \<= 1,299 cell/mm3 (African Americans) or \<= 1,699 cell/mm3 (all others), lymphocyte count \<= 799 cell/mm3, monocyte count \>= 1001 cell/mm3, eosinophil count \>= 871 cell/mm3, basophil count \>= 101 cell/mm3, and platelet count \<= 149 x 10\^3/mm3. If a result met the threshold for an AE at baseline, subsequent results were only considered to be an AE if the grading worsened in severity.
Outcome measures
| Measure |
SAD1
n=3 Participants
1 mg (1 injection of 0.1 mL diluted 1:10 in 5% Dextrose Injection, USP) of Rezafungin administered subcutaneously.
|
SAD2
n=6 Participants
10 mg (1 injection of 0.1 mL) of Rezafungin administered subcutaneously.
|
SAD Placebo
n=3 Participants
Placebo participants across all SAD cohorts given matching placebo administered subcutaneously as a single dose in a double-blind manner.
|
MAD4
200 mg (2 injections of 1.0 mL) of Rezafungin administered subcutaneously.
|
MAD Placebo
Placebo participants across all MAD cohorts given matching placebo administered subcutaneously.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Hematology Laboratory Toxicity Results for Single Ascending Dose (SAD) on Day 2
Any Parameter
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Hematology Laboratory Toxicity Results for Single Ascending Dose (SAD) on Day 2
White Blood Cell Count, Decrease
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Hematology Laboratory Toxicity Results for Single Ascending Dose (SAD) on Day 2
White Blood Cell Count, Increase
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Hematology Laboratory Toxicity Results for Single Ascending Dose (SAD) on Day 2
Neutrophil Count, Decrease
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Hematology Laboratory Toxicity Results for Single Ascending Dose (SAD) on Day 2
Monocyte Count, Increase
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Hematology Laboratory Toxicity Results for Single Ascending Dose (SAD) on Day 2
Basophil Count, Increase
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 7Population: Safety population: All participants that received any amount of study product.
Laboratory parameters and associated thresholds for adverse events include hemoglobin \<= 12.2 g/dL (male) or \<= 10.8 g/dL (female), hematocrit \<= 36.1 % (male) or \<= 32.6 % (female), red blood cell (RBC) count \<= 4.1 x 10\^6/uL (male) or \<= 3.7 x 10\^6/uL (female), white blood cell (WBC) count \>= 9,001 cell/mm3 or \<= 2,499 cell/mm3 (African American Males) or \>= 11,001 cell/mm3 or \<= 2,499 cell/mm3 (African American Females) or \>= 10,001 cell/mm3 or \<= 3,999 cell/mm3 (all others), neutrophil count \<= 1,299 cell/mm3 (African Americans) or \<= 1,699 cell/mm3 (all others), lymphocyte count \<= 799 cell/mm3, monocyte count \>= 1001 cell/mm3, eosinophil count \>= 871 cell/mm3, basophil count \>= 101 cell/mm3, and platelet count \<= 149 x 10\^3/mm3. If a result met the threshold for an AE at baseline, subsequent results were only considered to be an AE if the grading worsened in severity.
Outcome measures
| Measure |
SAD1
n=3 Participants
1 mg (1 injection of 0.1 mL diluted 1:10 in 5% Dextrose Injection, USP) of Rezafungin administered subcutaneously.
|
SAD2
n=6 Participants
10 mg (1 injection of 0.1 mL) of Rezafungin administered subcutaneously.
|
SAD Placebo
n=3 Participants
Placebo participants across all SAD cohorts given matching placebo administered subcutaneously as a single dose in a double-blind manner.
|
MAD4
200 mg (2 injections of 1.0 mL) of Rezafungin administered subcutaneously.
|
MAD Placebo
Placebo participants across all MAD cohorts given matching placebo administered subcutaneously.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Hematology Laboratory Toxicity Results for Single Ascending Dose (SAD) on Day 7
Any Parameter
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Hematology Laboratory Toxicity Results for Single Ascending Dose (SAD) on Day 7
White Blood Cell Count, Decrease
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Hematology Laboratory Toxicity Results for Single Ascending Dose (SAD) on Day 7
White Blood Cell Count, Increase
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 30Population: Safety population: All participants that received any amount of study product.
Laboratory parameters and associated thresholds for adverse events include hemoglobin \<= 12.2 g/dL (male) or \<= 10.8 g/dL (female), hematocrit \<= 36.1 % (male) or \<= 32.6 % (female), red blood cell (RBC) count \<= 4.1 x 10\^6/uL (male) or \<= 3.7 x 10\^6/uL (female), white blood cell (WBC) count \>= 9,001 cell/mm3 or \<= 2,499 cell/mm3 (African American Males) or \>= 11,001 cell/mm3 or \<= 2,499 cell/mm3 (African American Females) or \>= 10,001 cell/mm3 or \<= 3,999 cell/mm3 (all others), neutrophil count \<= 1,299 cell/mm3 (African Americans) or \<= 1,699 cell/mm3 (all others), lymphocyte count \<= 799 cell/mm3, monocyte count \>= 1001 cell/mm3, eosinophil count \>= 871 cell/mm3, basophil count \>= 101 cell/mm3, and platelet count \<= 149 x 10\^3/mm3. If a result met the threshold for an AE at baseline, subsequent results were only considered to be an AE if the grading worsened in severity.
Outcome measures
| Measure |
SAD1
n=3 Participants
1 mg (1 injection of 0.1 mL diluted 1:10 in 5% Dextrose Injection, USP) of Rezafungin administered subcutaneously.
|
SAD2
n=6 Participants
10 mg (1 injection of 0.1 mL) of Rezafungin administered subcutaneously.
|
SAD Placebo
n=3 Participants
Placebo participants across all SAD cohorts given matching placebo administered subcutaneously as a single dose in a double-blind manner.
|
MAD4
200 mg (2 injections of 1.0 mL) of Rezafungin administered subcutaneously.
|
MAD Placebo
Placebo participants across all MAD cohorts given matching placebo administered subcutaneously.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Hematology Laboratory Toxicity Results for Single Ascending Dose (SAD) on Day 30
Any Parameter
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Hematology Laboratory Toxicity Results for Single Ascending Dose (SAD) on Day 30
Neutrophil Count, Decrease
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Hematology Laboratory Toxicity Results for Single Ascending Dose (SAD) on Day 30
Eosinophil Count, Increase
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 2 through Day 45Population: The study was terminated on 27APR2020 due to safety concerns. No subjects were enrolled into these groups.
Laboratory parameters and associated thresholds for adverse events include hemoglobin \<= 12.2 g/dL (male) or \<= 10.8 g/dL (female), hematocrit \<= 36.1 % (male) or \<= 32.6 % (female), red blood cell (RBC) count \<= 4.1 x 10\^6/uL (male) or \<= 3.7 x 10\^6/uL (female), white blood cell (WBC) count \>= 9,001 cell/mm3 or \<= 2,499 cell/mm3 (African American Males) or \>= 11,001 cell/mm3 or \<= 2,499 cell/mm3 (African American Females) or \>= 10,001 cell/mm3 or \<= 3,999 cell/mm3 (all others), neutrophil count \<= 1,299 cell/mm3 (African Americans) or \<= 1,699 cell/mm3 (all others), lymphocyte count \<= 799 cell/mm3, monocyte count \>= 1001 cell/mm3, eosinophil count \>= 871 cell/mm3, basophil count \>= 101 cell/mm3, and platelet count \<= 149 x 10\^3/mm3. If a result met the threshold for an AE at baseline, subsequent results were only considered to be an AE if the grading worsened in severity.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 2Population: Safety population: All participants that received any amount of study product.
Laboratory parameters include prothrombin time (PT), activated partial prothrombin time (PTT), and prothrombin international normalized ratio (INR). Thresholds for adverse events were considered as PT \>= 11.1 s (before 23DEC2019) or \>= 11.6 s (on or after 23DEC2019), PTT \>= 34.1 s (before 23DEC2019) or \>= 30.1 (on or after 23DEC2019), INR \>= 1.2. If a coagulation laboratory value met the threshold for an AE at baseline, subsequent safety laboratory results were only considered to be an AE if the grading worsened in severity.
Outcome measures
| Measure |
SAD1
n=3 Participants
1 mg (1 injection of 0.1 mL diluted 1:10 in 5% Dextrose Injection, USP) of Rezafungin administered subcutaneously.
|
SAD2
n=6 Participants
10 mg (1 injection of 0.1 mL) of Rezafungin administered subcutaneously.
|
SAD Placebo
n=3 Participants
Placebo participants across all SAD cohorts given matching placebo administered subcutaneously as a single dose in a double-blind manner.
|
MAD4
200 mg (2 injections of 1.0 mL) of Rezafungin administered subcutaneously.
|
MAD Placebo
Placebo participants across all MAD cohorts given matching placebo administered subcutaneously.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Coagulation Laboratory Toxicity Results for Single Ascending Dose (SAD), Day 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 7Population: Safety population: All participants that received any amount of study product.
Laboratory parameters include prothrombin time (PT), activated partial prothrombin time (PTT), and prothrombin international normalized ratio (INR). Thresholds for adverse events were considered as PT \>= 11.1 s (before 23DEC2019) or \>= 11.6 s (on or after 23DEC2019), PTT \>= 34.1 s (before 23DEC2019) or \>= 30.1 (on or after 23DEC2019), INR \>= 1.2. If a coagulation laboratory value met the threshold for an AE at baseline, subsequent safety laboratory results were only considered to be an AE if the grading worsened in severity.
Outcome measures
| Measure |
SAD1
n=3 Participants
1 mg (1 injection of 0.1 mL diluted 1:10 in 5% Dextrose Injection, USP) of Rezafungin administered subcutaneously.
|
SAD2
n=6 Participants
10 mg (1 injection of 0.1 mL) of Rezafungin administered subcutaneously.
|
SAD Placebo
n=3 Participants
Placebo participants across all SAD cohorts given matching placebo administered subcutaneously as a single dose in a double-blind manner.
|
MAD4
200 mg (2 injections of 1.0 mL) of Rezafungin administered subcutaneously.
|
MAD Placebo
Placebo participants across all MAD cohorts given matching placebo administered subcutaneously.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Coagulation Laboratory Toxicity Results for Single Ascending Dose (SAD), Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 30Population: Safety population: All participants that received any amount of study product.
Laboratory parameters include prothrombin time (PT), activated partial prothrombin time (PTT), and prothrombin international normalized ratio (INR). Thresholds for adverse events were considered as PT \>= 11.1 s (before 23DEC2019) or \>= 11.6 s (on or after 23DEC2019), PTT \>= 34.1 s (before 23DEC2019) or \>= 30.1 (on or after 23DEC2019), INR \>= 1.2. If a coagulation laboratory value met the threshold for an AE at baseline, subsequent safety laboratory results were only considered to be an AE if the grading worsened in severity.
Outcome measures
| Measure |
SAD1
n=3 Participants
1 mg (1 injection of 0.1 mL diluted 1:10 in 5% Dextrose Injection, USP) of Rezafungin administered subcutaneously.
|
SAD2
n=6 Participants
10 mg (1 injection of 0.1 mL) of Rezafungin administered subcutaneously.
|
SAD Placebo
n=3 Participants
Placebo participants across all SAD cohorts given matching placebo administered subcutaneously as a single dose in a double-blind manner.
|
MAD4
200 mg (2 injections of 1.0 mL) of Rezafungin administered subcutaneously.
|
MAD Placebo
Placebo participants across all MAD cohorts given matching placebo administered subcutaneously.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Coagulation Laboratory Toxicity Results for Single Ascending Dose (SAD), Day 30
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 2 through Day 45Population: The study was terminated on 27APR2020 due to safety concerns. No subjects were enrolled into these groups.
Laboratory parameters include prothrombin time (PT), activated partial prothrombin time (PTT), and prothrombin international normalized ratio (INR). Thresholds for adverse events were considered as PT \>= 11.1 s (before 23DEC2019) or \>= 11.6 s (on or after 23DEC2019), PTT \>= 34.1 s (before 23DEC2019) or \>= 30.1 (on or after 23DEC2019), INR \>= 1.2. If a coagulation laboratory value met the threshold for an AE at baseline, subsequent safety laboratory results were only considered to be an AE if the grading worsened in severity.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 2Population: Safety population: All participants that received any amount of study product.
Laboratory parameters include protein, glucose, and occult blood. Thresholds for adverse events were considered as protein \>= 1+, glucose \>= 1+, and occult blood \>= 5 (before 23DEC2019) or \>=3 (on or after 23DEC2019). If a urinalysis laboratory value met the threshold for an AE at baseline, subsequent safety laboratory results were only considered to be an AE if the grading worsened in severity.
Outcome measures
| Measure |
SAD1
n=3 Participants
1 mg (1 injection of 0.1 mL diluted 1:10 in 5% Dextrose Injection, USP) of Rezafungin administered subcutaneously.
|
SAD2
n=6 Participants
10 mg (1 injection of 0.1 mL) of Rezafungin administered subcutaneously.
|
SAD Placebo
n=3 Participants
Placebo participants across all SAD cohorts given matching placebo administered subcutaneously as a single dose in a double-blind manner.
|
MAD4
200 mg (2 injections of 1.0 mL) of Rezafungin administered subcutaneously.
|
MAD Placebo
Placebo participants across all MAD cohorts given matching placebo administered subcutaneously.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Urinalysis Laboratory Toxicity Results for Single Ascending Dose (SAD), Day 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 7Population: Safety population: All participants that received any amount of study product.
Laboratory parameters include protein, glucose, and occult blood. Thresholds for adverse events were considered as protein \>= 1+, glucose \>= 1+, and occult blood \>= 5 (before 23DEC2019) or \>=3 (on or after 23DEC2019). If a urinalysis laboratory value met the threshold for an AE at baseline, subsequent safety laboratory results were only considered to be an AE if the grading worsened in severity.
Outcome measures
| Measure |
SAD1
n=3 Participants
1 mg (1 injection of 0.1 mL diluted 1:10 in 5% Dextrose Injection, USP) of Rezafungin administered subcutaneously.
|
SAD2
n=6 Participants
10 mg (1 injection of 0.1 mL) of Rezafungin administered subcutaneously.
|
SAD Placebo
n=3 Participants
Placebo participants across all SAD cohorts given matching placebo administered subcutaneously as a single dose in a double-blind manner.
|
MAD4
200 mg (2 injections of 1.0 mL) of Rezafungin administered subcutaneously.
|
MAD Placebo
Placebo participants across all MAD cohorts given matching placebo administered subcutaneously.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Urinalysis Laboratory Toxicity Results for Single Ascending Dose (SAD), Day 7
Any Parameter
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Laboratory Toxicity Results for Single Ascending Dose (SAD), Day 7
Protein by Dipstick
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 30Population: Safety population: All participants that received any amount of study product.
Laboratory parameters include protein, glucose, and occult blood. Thresholds for adverse events were considered as protein \>= 1+, glucose \>= 1+, and occult blood \>= 5 (before 23DEC2019) or \>=3 (on or after 23DEC2019). If a urinalysis laboratory value met the threshold for an AE at baseline, subsequent safety laboratory results were only considered to be an AE if the grading worsened in severity.
Outcome measures
| Measure |
SAD1
n=3 Participants
1 mg (1 injection of 0.1 mL diluted 1:10 in 5% Dextrose Injection, USP) of Rezafungin administered subcutaneously.
|
SAD2
n=6 Participants
10 mg (1 injection of 0.1 mL) of Rezafungin administered subcutaneously.
|
SAD Placebo
n=3 Participants
Placebo participants across all SAD cohorts given matching placebo administered subcutaneously as a single dose in a double-blind manner.
|
MAD4
200 mg (2 injections of 1.0 mL) of Rezafungin administered subcutaneously.
|
MAD Placebo
Placebo participants across all MAD cohorts given matching placebo administered subcutaneously.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Urinalysis Laboratory Toxicity Results for Single Ascending Dose (SAD), Day 30
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 2 through Day 45Population: The study was terminated on 27APR2020 due to safety concerns. No subjects were enrolled into these groups.
Each subject is only counted once per toxicity grade for the worst severity recorded. Laboratory parameters include protein, glucose, and occult blood. Thresholds for adverse events were considered as protein \>= 1+, glucose \>= 1+, and occult blood \>= 5 (before 23DEC2019) or \>=3 (on or after 23DEC2019). If a urinalysis laboratory value met the threshold for an AE at baseline, subsequent safety laboratory results were only considered to be an AE if the grading worsened in severity.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1Population: Safety population: All participants that received any amount of study product.
Each subject is only counted once per toxicity grade for the worst severity recorded. ECG parameters include PR interval and QTcF interval. Thresholds for adverse events were considered as PR interval \>= 0.21 sec, a type II 2nd degree AV block, or ventricular pause \>3 sec and QTcF interval \>= 450 msec or \>= 30 msec above baseline. If an ECG value met the threshold for an AE at baseline, subsequent safety ECG results were only considered to be an AE if the grading worsened in severity.
Outcome measures
| Measure |
SAD1
n=3 Participants
1 mg (1 injection of 0.1 mL diluted 1:10 in 5% Dextrose Injection, USP) of Rezafungin administered subcutaneously.
|
SAD2
n=6 Participants
10 mg (1 injection of 0.1 mL) of Rezafungin administered subcutaneously.
|
SAD Placebo
n=3 Participants
Placebo participants across all SAD cohorts given matching placebo administered subcutaneously as a single dose in a double-blind manner.
|
MAD4
200 mg (2 injections of 1.0 mL) of Rezafungin administered subcutaneously.
|
MAD Placebo
Placebo participants across all MAD cohorts given matching placebo administered subcutaneously.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal ECG Toxicity Results for Single Ascending Dose (SAD), Day 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 7Population: Safety population: All participants that received any amount of study product.
Each subject is only counted once per toxicity grade for the worst severity recorded. ECG parameters include PR interval and QTcF interval. Thresholds for adverse events were considered as PR interval \>= 0.21 sec, a type II 2nd degree AV block, or ventricular pause \>3 sec and QTcF interval \>= 450 msec or \>= 30 msec above baseline. If an ECG value met the threshold for an AE at baseline, subsequent safety ECG results were only considered to be an AE if the grading worsened in severity.
Outcome measures
| Measure |
SAD1
n=3 Participants
1 mg (1 injection of 0.1 mL diluted 1:10 in 5% Dextrose Injection, USP) of Rezafungin administered subcutaneously.
|
SAD2
n=6 Participants
10 mg (1 injection of 0.1 mL) of Rezafungin administered subcutaneously.
|
SAD Placebo
n=3 Participants
Placebo participants across all SAD cohorts given matching placebo administered subcutaneously as a single dose in a double-blind manner.
|
MAD4
200 mg (2 injections of 1.0 mL) of Rezafungin administered subcutaneously.
|
MAD Placebo
Placebo participants across all MAD cohorts given matching placebo administered subcutaneously.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal ECG Toxicity Results for Single Ascending Dose (SAD), Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 30Population: Safety population: All participants that received any amount of study product.
Each subject is only counted once per toxicity grade for the worst severity recorded. ECG parameters include PR interval and QTcF interval. Thresholds for adverse events were considered as PR interval \>= 0.21 sec, a type II 2nd degree AV block, or ventricular pause \>3 sec and QTcF interval \>= 450 msec or \>= 30 msec above baseline. If an ECG value met the threshold for an AE at baseline, subsequent safety ECG results were only considered to be an AE if the grading worsened in severity.
Outcome measures
| Measure |
SAD1
n=3 Participants
1 mg (1 injection of 0.1 mL diluted 1:10 in 5% Dextrose Injection, USP) of Rezafungin administered subcutaneously.
|
SAD2
n=6 Participants
10 mg (1 injection of 0.1 mL) of Rezafungin administered subcutaneously.
|
SAD Placebo
n=3 Participants
Placebo participants across all SAD cohorts given matching placebo administered subcutaneously as a single dose in a double-blind manner.
|
MAD4
200 mg (2 injections of 1.0 mL) of Rezafungin administered subcutaneously.
|
MAD Placebo
Placebo participants across all MAD cohorts given matching placebo administered subcutaneously.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal ECG Toxicity Results for Single Ascending Dose (SAD), Day 30
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 through Day 45Population: The study was terminated on 27APR2020 due to safety concerns. No subjects were enrolled into these groups.
This table includes the maximum severity experienced over all post-baseline time points. ECG parameters include PR interval and QTcF interval. Thresholds for adverse events were considered as PR interval \>= 0.21 sec, a type II 2nd degree AV block, or ventricular pause \>3 sec and QTcF interval \>= 450 msec or \>= 30 msec above baseline. If an ECG value met the threshold for an AE at baseline, subsequent safety ECG results were only considered to be an AE if the grading worsened in severity.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1Population: Safety population: All participants that received any amount of study product.
Physical examination includes general appearance; head, eyes, nose and throat; neck; chest and lungs; cardiovascular system, abdomen, musculoskeletal system, lymph nodes, extremities/skin, and neurological system.
Outcome measures
| Measure |
SAD1
n=3 Participants
1 mg (1 injection of 0.1 mL diluted 1:10 in 5% Dextrose Injection, USP) of Rezafungin administered subcutaneously.
|
SAD2
n=6 Participants
10 mg (1 injection of 0.1 mL) of Rezafungin administered subcutaneously.
|
SAD Placebo
n=3 Participants
Placebo participants across all SAD cohorts given matching placebo administered subcutaneously as a single dose in a double-blind manner.
|
MAD4
200 mg (2 injections of 1.0 mL) of Rezafungin administered subcutaneously.
|
MAD Placebo
Placebo participants across all MAD cohorts given matching placebo administered subcutaneously.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Physical Exams for Single Ascending Dose (SAD), Day 1
Any Parameter
|
0 participants
|
1 participants
|
0 participants
|
—
|
—
|
|
Number of Participants With Abnormal Physical Exams for Single Ascending Dose (SAD), Day 1
Extremities/skin
|
0 participants
|
1 participants
|
0 participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 2Population: Safety population: All participants that received any amount of study product.
Physical examination includes general appearance; head, eyes, nose and throat; neck; chest and lungs; cardiovascular system, abdomen, musculoskeletal system, lymph nodes, extremities/skin, and neurological system.
Outcome measures
| Measure |
SAD1
n=3 Participants
1 mg (1 injection of 0.1 mL diluted 1:10 in 5% Dextrose Injection, USP) of Rezafungin administered subcutaneously.
|
SAD2
n=6 Participants
10 mg (1 injection of 0.1 mL) of Rezafungin administered subcutaneously.
|
SAD Placebo
n=3 Participants
Placebo participants across all SAD cohorts given matching placebo administered subcutaneously as a single dose in a double-blind manner.
|
MAD4
200 mg (2 injections of 1.0 mL) of Rezafungin administered subcutaneously.
|
MAD Placebo
Placebo participants across all MAD cohorts given matching placebo administered subcutaneously.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Physical Exams for Single Ascending Dose (SAD), Day 2
Any Parameter
|
0 participants
|
6 participants
|
0 participants
|
—
|
—
|
|
Number of Participants With Abnormal Physical Exams for Single Ascending Dose (SAD), Day 2
Extremities/skin
|
0 participants
|
6 participants
|
0 participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 4Population: Safety population: All participants that received any amount of study product.
Physical examination includes general appearance; head, eyes, nose and throat; neck; chest and lungs; cardiovascular system, abdomen, musculoskeletal system, lymph nodes, extremities/skin, and neurological system.
Outcome measures
| Measure |
SAD1
n=3 Participants
1 mg (1 injection of 0.1 mL diluted 1:10 in 5% Dextrose Injection, USP) of Rezafungin administered subcutaneously.
|
SAD2
n=6 Participants
10 mg (1 injection of 0.1 mL) of Rezafungin administered subcutaneously.
|
SAD Placebo
n=3 Participants
Placebo participants across all SAD cohorts given matching placebo administered subcutaneously as a single dose in a double-blind manner.
|
MAD4
200 mg (2 injections of 1.0 mL) of Rezafungin administered subcutaneously.
|
MAD Placebo
Placebo participants across all MAD cohorts given matching placebo administered subcutaneously.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Physical Exams for Single Ascending Dose (SAD), Day 4
Any Parameter
|
0 participants
|
5 participants
|
0 participants
|
—
|
—
|
|
Number of Participants With Abnormal Physical Exams for Single Ascending Dose (SAD), Day 4
Extremities/skin
|
0 participants
|
5 participants
|
0 participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 7Population: Safety population: All participants that received any amount of study product.
Physical examination includes general appearance; head, eyes, nose and throat; neck; chest and lungs; cardiovascular system, abdomen, musculoskeletal system, lymph nodes, extremities/skin, and neurological system.
Outcome measures
| Measure |
SAD1
n=3 Participants
1 mg (1 injection of 0.1 mL diluted 1:10 in 5% Dextrose Injection, USP) of Rezafungin administered subcutaneously.
|
SAD2
n=6 Participants
10 mg (1 injection of 0.1 mL) of Rezafungin administered subcutaneously.
|
SAD Placebo
n=3 Participants
Placebo participants across all SAD cohorts given matching placebo administered subcutaneously as a single dose in a double-blind manner.
|
MAD4
200 mg (2 injections of 1.0 mL) of Rezafungin administered subcutaneously.
|
MAD Placebo
Placebo participants across all MAD cohorts given matching placebo administered subcutaneously.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Physical Exams for Single Ascending Dose (SAD), Day 7
Any Parameter
|
0 participants
|
1 participants
|
0 participants
|
—
|
—
|
|
Number of Participants With Abnormal Physical Exams for Single Ascending Dose (SAD), Day 7
Extremities/skin
|
0 participants
|
1 participants
|
0 participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 30Population: Safety population: All participants that received any amount of study product.
Physical examination includes general appearance; head, eyes, nose and throat; neck; chest and lungs; cardiovascular system, abdomen, musculoskeletal system, lymph nodes, extremities/skin, and neurological system.
Outcome measures
| Measure |
SAD1
n=3 Participants
1 mg (1 injection of 0.1 mL diluted 1:10 in 5% Dextrose Injection, USP) of Rezafungin administered subcutaneously.
|
SAD2
n=6 Participants
10 mg (1 injection of 0.1 mL) of Rezafungin administered subcutaneously.
|
SAD Placebo
n=3 Participants
Placebo participants across all SAD cohorts given matching placebo administered subcutaneously as a single dose in a double-blind manner.
|
MAD4
200 mg (2 injections of 1.0 mL) of Rezafungin administered subcutaneously.
|
MAD Placebo
Placebo participants across all MAD cohorts given matching placebo administered subcutaneously.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Physical Exams for Single Ascending Dose (SAD), Day 30
Any Parameter
|
0 participants
|
2 participants
|
0 participants
|
—
|
—
|
|
Number of Participants With Abnormal Physical Exams for Single Ascending Dose (SAD), Day 30
Extremities/skin
|
0 participants
|
2 participants
|
0 participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 through Day 45Population: The study was terminated on 27APR2020 due to safety concerns. No subjects were enrolled into these groups.
Physical examination includes general appearance; head, eyes, nose and throat; neck; chest and lungs; cardiovascular system, abdomen, musculoskeletal system, lymph nodes, extremities/skin, and neurological system.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1, 15 minutes post-dosePopulation: Safety population: All participants that received any amount of study product.
Each subject is only counted once per toxicity grade for the worst severity recorded. Vital sign parameters include systolic blood pressure (BP), diastolic BP, heart rate, respiratory rate, and temperature. Thresholds for abnormal vital signs were considered as systolic BP \>= 141 mmHg or \<= 89 mmHg, diastolic BP \>= 91 mmHg, heart rate \<= 54 bpm (baseline \>= 60 bpm) or \<=50 (baseline \< 60 bpm) or \>= 101 bpm, respiratory rate \>= 23 breaths per minute, and temperature \>= 38.0 degrees Celsius. If a vital sign result met the threshold for an AE at baseline, subsequent vital sign results were only considered to be an AE if the grading worsened in severity.
Outcome measures
| Measure |
SAD1
n=3 Participants
1 mg (1 injection of 0.1 mL diluted 1:10 in 5% Dextrose Injection, USP) of Rezafungin administered subcutaneously.
|
SAD2
n=6 Participants
10 mg (1 injection of 0.1 mL) of Rezafungin administered subcutaneously.
|
SAD Placebo
n=3 Participants
Placebo participants across all SAD cohorts given matching placebo administered subcutaneously as a single dose in a double-blind manner.
|
MAD4
200 mg (2 injections of 1.0 mL) of Rezafungin administered subcutaneously.
|
MAD Placebo
Placebo participants across all MAD cohorts given matching placebo administered subcutaneously.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Vital Signs for Single Ascending Dose (SAD), Day 1, 15 Minutes Post-dose
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1, 1 hour post-dosePopulation: Safety population: All participants that received any amount of study product.
Each subject is only counted once per toxicity grade for the worst severity recorded. Vital sign parameters include systolic blood pressure (BP), diastolic BP, heart rate, respiratory rate, and temperature. Thresholds for abnormal vital signs were considered as systolic BP \>= 141 mmHg or \<= 89 mmHg, diastolic BP \>= 91 mmHg, heart rate \<= 54 bpm (baseline \>= 60 bpm) or \<=50 (baseline \< 60 bpm) or \>= 101 bpm, respiratory rate \>= 23 breaths per minute, and temperature \>= 38.0 degrees Celsius. If a vital sign result met the threshold for an AE at baseline, subsequent vital sign results were only considered to be an AE if the grading worsened in severity.
Outcome measures
| Measure |
SAD1
n=3 Participants
1 mg (1 injection of 0.1 mL diluted 1:10 in 5% Dextrose Injection, USP) of Rezafungin administered subcutaneously.
|
SAD2
n=6 Participants
10 mg (1 injection of 0.1 mL) of Rezafungin administered subcutaneously.
|
SAD Placebo
n=3 Participants
Placebo participants across all SAD cohorts given matching placebo administered subcutaneously as a single dose in a double-blind manner.
|
MAD4
200 mg (2 injections of 1.0 mL) of Rezafungin administered subcutaneously.
|
MAD Placebo
Placebo participants across all MAD cohorts given matching placebo administered subcutaneously.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Vital Signs for Single Ascending Dose (SAD), Day 1, 1 Hour Post-dose
Any Parameter
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Vital Signs for Single Ascending Dose (SAD), Day 1, 1 Hour Post-dose
Heart Rate, Decrease
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1, 2 hours post-dosePopulation: Safety population: All participants that received any amount of study product.
Each subject is only counted once per toxicity grade for the worst severity recorded. Vital sign parameters include systolic blood pressure (BP), diastolic BP, heart rate, respiratory rate, and temperature. Thresholds for abnormal vital signs were considered as systolic BP \>= 141 mmHg or \<= 89 mmHg, diastolic BP \>= 91 mmHg, heart rate \<= 54 bpm (baseline \>= 60 bpm) or \<=50 (baseline \< 60 bpm) or \>= 101 bpm, respiratory rate \>= 23 breaths per minute, and temperature \>= 38.0 degrees Celsius. If a vital sign result met the threshold for an AE at baseline, subsequent vital sign results were only considered to be an AE if the grading worsened in severity.
Outcome measures
| Measure |
SAD1
n=3 Participants
1 mg (1 injection of 0.1 mL diluted 1:10 in 5% Dextrose Injection, USP) of Rezafungin administered subcutaneously.
|
SAD2
n=6 Participants
10 mg (1 injection of 0.1 mL) of Rezafungin administered subcutaneously.
|
SAD Placebo
n=3 Participants
Placebo participants across all SAD cohorts given matching placebo administered subcutaneously as a single dose in a double-blind manner.
|
MAD4
200 mg (2 injections of 1.0 mL) of Rezafungin administered subcutaneously.
|
MAD Placebo
Placebo participants across all MAD cohorts given matching placebo administered subcutaneously.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Vital Signs for Single Ascending Dose (SAD), Day 1, 2 Hours Post-dose
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 2Population: Safety population: All participants that received any amount of study product.
Each subject is only counted once per toxicity grade for the worst severity recorded. Vital sign parameters include systolic blood pressure (BP), diastolic BP, heart rate, respiratory rate, and temperature. Thresholds for abnormal vital signs were considered as systolic BP \>= 141 mmHg or \<= 89 mmHg, diastolic BP \>= 91 mmHg, heart rate \<= 54 bpm (baseline \>= 60 bpm) or \<=50 (baseline \< 60 bpm) or \>= 101 bpm, respiratory rate \>= 23 breaths per minute, and temperature \>= 38.0 degrees Celsius. If a vital sign result met the threshold for an AE at baseline, subsequent vital sign results were only considered to be an AE if the grading worsened in severity.
Outcome measures
| Measure |
SAD1
n=3 Participants
1 mg (1 injection of 0.1 mL diluted 1:10 in 5% Dextrose Injection, USP) of Rezafungin administered subcutaneously.
|
SAD2
n=6 Participants
10 mg (1 injection of 0.1 mL) of Rezafungin administered subcutaneously.
|
SAD Placebo
n=3 Participants
Placebo participants across all SAD cohorts given matching placebo administered subcutaneously as a single dose in a double-blind manner.
|
MAD4
200 mg (2 injections of 1.0 mL) of Rezafungin administered subcutaneously.
|
MAD Placebo
Placebo participants across all MAD cohorts given matching placebo administered subcutaneously.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Vital Signs for Single Ascending Dose (SAD), Day 2
Any Parameter
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Vital Signs for Single Ascending Dose (SAD), Day 2
Heart Rate, Decrease
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 4Population: Safety population: All participants that received any amount of study product.
Each subject is only counted once per toxicity grade for the worst severity recorded. Vital sign parameters include systolic blood pressure (BP), diastolic BP, heart rate, respiratory rate, and temperature. Thresholds for abnormal vital signs were considered as systolic BP \>= 141 mmHg or \<= 89 mmHg, diastolic BP \>= 91 mmHg, heart rate \<= 54 bpm (baseline \>= 60 bpm) or \<=50 (baseline \< 60 bpm) or \>= 101 bpm, respiratory rate \>= 23 breaths per minute, and temperature \>= 38.0 degrees Celsius. If a vital sign result met the threshold for an AE at baseline, subsequent vital sign results were only considered to be an AE if the grading worsened in severity.
Outcome measures
| Measure |
SAD1
n=3 Participants
1 mg (1 injection of 0.1 mL diluted 1:10 in 5% Dextrose Injection, USP) of Rezafungin administered subcutaneously.
|
SAD2
n=6 Participants
10 mg (1 injection of 0.1 mL) of Rezafungin administered subcutaneously.
|
SAD Placebo
n=3 Participants
Placebo participants across all SAD cohorts given matching placebo administered subcutaneously as a single dose in a double-blind manner.
|
MAD4
200 mg (2 injections of 1.0 mL) of Rezafungin administered subcutaneously.
|
MAD Placebo
Placebo participants across all MAD cohorts given matching placebo administered subcutaneously.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Vital Signs for Single Ascending Dose (SAD), Day 4
Any Parameter
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Vital Signs for Single Ascending Dose (SAD), Day 4
Heart Rate, Decrease
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 7Population: Safety population: All participants that received any amount of study product.
Each subject is only counted once per toxicity grade for the worst severity recorded. Vital sign parameters include systolic blood pressure (BP), diastolic BP, heart rate, respiratory rate, and temperature. Thresholds for abnormal vital signs were considered as systolic BP \>= 141 mmHg or \<= 89 mmHg, diastolic BP \>= 91 mmHg, heart rate \<= 54 bpm (baseline \>= 60 bpm) or \<=50 (baseline \< 60 bpm) or \>= 101 bpm, respiratory rate \>= 23 breaths per minute, and temperature \>= 38.0 degrees Celsius. If a vital sign result met the threshold for an AE at baseline, subsequent vital sign results were only considered to be an AE if the grading worsened in severity.
Outcome measures
| Measure |
SAD1
n=3 Participants
1 mg (1 injection of 0.1 mL diluted 1:10 in 5% Dextrose Injection, USP) of Rezafungin administered subcutaneously.
|
SAD2
n=6 Participants
10 mg (1 injection of 0.1 mL) of Rezafungin administered subcutaneously.
|
SAD Placebo
n=3 Participants
Placebo participants across all SAD cohorts given matching placebo administered subcutaneously as a single dose in a double-blind manner.
|
MAD4
200 mg (2 injections of 1.0 mL) of Rezafungin administered subcutaneously.
|
MAD Placebo
Placebo participants across all MAD cohorts given matching placebo administered subcutaneously.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Vital Signs for Single Ascending Dose (SAD), Day 7
Any Parameter
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Vital Signs for Single Ascending Dose (SAD), Day 7
Heart Rate, Decrease
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 14Population: Safety population: All participants that received any amount of study product.
Each subject is only counted once per toxicity grade for the worst severity recorded. Vital sign parameters include systolic blood pressure (BP), diastolic BP, heart rate, respiratory rate, and temperature. Thresholds for abnormal vital signs were considered as systolic BP \>= 141 mmHg or \<= 89 mmHg, diastolic BP \>= 91 mmHg, heart rate \<= 54 bpm (baseline \>= 60 bpm) or \<=50 (baseline \< 60 bpm) or \>= 101 bpm, respiratory rate \>= 23 breaths per minute, and temperature \>= 38.0 degrees Celsius. If a vital sign result met the threshold for an AE at baseline, subsequent vital sign results were only considered to be an AE if the grading worsened in severity.
Outcome measures
| Measure |
SAD1
n=3 Participants
1 mg (1 injection of 0.1 mL diluted 1:10 in 5% Dextrose Injection, USP) of Rezafungin administered subcutaneously.
|
SAD2
n=6 Participants
10 mg (1 injection of 0.1 mL) of Rezafungin administered subcutaneously.
|
SAD Placebo
n=3 Participants
Placebo participants across all SAD cohorts given matching placebo administered subcutaneously as a single dose in a double-blind manner.
|
MAD4
200 mg (2 injections of 1.0 mL) of Rezafungin administered subcutaneously.
|
MAD Placebo
Placebo participants across all MAD cohorts given matching placebo administered subcutaneously.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Vital Signs for Single Ascending Dose (SAD), Day 14
Any Parameter
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Vital Signs for Single Ascending Dose (SAD), Day 14
Heart Rate, Decrease
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 30Population: Safety population: All participants that received any amount of study product.
Each subject is only counted once per toxicity grade for the worst severity recorded. Vital sign parameters include systolic blood pressure (BP), diastolic BP, heart rate, respiratory rate, and temperature. Thresholds for abnormal vital signs were considered as systolic BP \>= 141 mmHg or \<= 89 mmHg, diastolic BP \>= 91 mmHg, heart rate \<= 54 bpm (baseline \>= 60 bpm) or \<=50 (baseline \< 60 bpm) or \>= 101 bpm, respiratory rate \>= 23 breaths per minute, and temperature \>= 38.0 degrees Celsius. If a vital sign result met the threshold for an AE at baseline, subsequent vital sign results were only considered to be an AE if the grading worsened in severity.
Outcome measures
| Measure |
SAD1
n=3 Participants
1 mg (1 injection of 0.1 mL diluted 1:10 in 5% Dextrose Injection, USP) of Rezafungin administered subcutaneously.
|
SAD2
n=6 Participants
10 mg (1 injection of 0.1 mL) of Rezafungin administered subcutaneously.
|
SAD Placebo
n=3 Participants
Placebo participants across all SAD cohorts given matching placebo administered subcutaneously as a single dose in a double-blind manner.
|
MAD4
200 mg (2 injections of 1.0 mL) of Rezafungin administered subcutaneously.
|
MAD Placebo
Placebo participants across all MAD cohorts given matching placebo administered subcutaneously.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Vital Signs for Single Ascending Dose (SAD), Day 30
Any Parameter
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Vital Signs for Single Ascending Dose (SAD), Day 30
Heart Rate, Decrease
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 through Day 45Population: The study was terminated on 27APR2020 due to safety concerns. No subjects were enrolled into this group.
Each subject is only counted once per toxicity grade for the worst severity recorded. Vital sign parameters include systolic blood pressure (BP), diastolic BP, heart rate, respiratory rate, and temperature. Thresholds for abnormal vital signs were considered as systolic BP \>= 141 mmHg or \<= 89 mmHg, diastolic BP \>= 91 mmHg, heart rate \<= 54 bpm (baseline \>= 60 bpm) or \<=50 (baseline \< 60 bpm) or \>= 101 bpm, respiratory rate \>= 23 breaths per minute, and temperature \>= 38.0 degrees Celsius. If a vital sign result met the threshold for an AE at baseline, subsequent vital sign results were only considered to be an AE if the grading worsened in severity.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1 through Day 30.Population: Safety population: All participants that received any amount of study product.
Number of participants with an AE are summarized by MedDRA System Organ Class (SOC) and severity. If a condition was present at screening it was not considered an AE unless the severity worsened.
Outcome measures
| Measure |
SAD1
n=3 Participants
1 mg (1 injection of 0.1 mL diluted 1:10 in 5% Dextrose Injection, USP) of Rezafungin administered subcutaneously.
|
SAD2
n=6 Participants
10 mg (1 injection of 0.1 mL) of Rezafungin administered subcutaneously.
|
SAD Placebo
n=3 Participants
Placebo participants across all SAD cohorts given matching placebo administered subcutaneously as a single dose in a double-blind manner.
|
MAD4
200 mg (2 injections of 1.0 mL) of Rezafungin administered subcutaneously.
|
MAD Placebo
Placebo participants across all MAD cohorts given matching placebo administered subcutaneously.
|
|---|---|---|---|---|---|
|
Number of Participants With Unsolicited Adverse Events (AEs) for Single Ascending Dose (SAD)
Any SOC
|
3 Participants
|
6 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Unsolicited Adverse Events (AEs) for Single Ascending Dose (SAD)
Investigations
|
2 Participants
|
5 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Unsolicited Adverse Events (AEs) for Single Ascending Dose (SAD)
Cardiac disorders
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Unsolicited Adverse Events (AEs) for Single Ascending Dose (SAD)
General disorders and administration site conditions
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 through Day 45Population: The study was terminated on 27APR2020 due to safety concerns. No subjects were enrolled into any MAD cohorts.
Number of participants with an AE are summarized by MedDRA System Organ Class (SOC). Each subject was counted once per SOC. If a condition was present at screening, it was not considered an AE unless the severity worsened.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1 through Day 30.Population: Safety population: All participants that received any amount of study product.
The total number of unsolicited AE events reported summarized by MedDRA System Organ Class (SOC). If a condition was present at screening it was not considered an AE unless the severity worsened.
Outcome measures
| Measure |
SAD1
n=3 Participants
1 mg (1 injection of 0.1 mL diluted 1:10 in 5% Dextrose Injection, USP) of Rezafungin administered subcutaneously.
|
SAD2
n=6 Participants
10 mg (1 injection of 0.1 mL) of Rezafungin administered subcutaneously.
|
SAD Placebo
n=3 Participants
Placebo participants across all SAD cohorts given matching placebo administered subcutaneously as a single dose in a double-blind manner.
|
MAD4
200 mg (2 injections of 1.0 mL) of Rezafungin administered subcutaneously.
|
MAD Placebo
Placebo participants across all MAD cohorts given matching placebo administered subcutaneously.
|
|---|---|---|---|---|---|
|
Number of Unsolicited Adverse Events Reported for Single Ascending Dose (SAD)
Any SOC
|
8 AE events
|
14 AE events
|
2 AE events
|
—
|
—
|
|
Number of Unsolicited Adverse Events Reported for Single Ascending Dose (SAD)
Investigations
|
4 AE events
|
8 AE events
|
2 AE events
|
—
|
—
|
|
Number of Unsolicited Adverse Events Reported for Single Ascending Dose (SAD)
Cardiac Disorders
|
0 AE events
|
2 AE events
|
0 AE events
|
—
|
—
|
|
Number of Unsolicited Adverse Events Reported for Single Ascending Dose (SAD)
General disorders and administration site conditions
|
0 AE events
|
2 AE events
|
0 AE events
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 through Day 45Population: The study was terminated on 27APR2020 due to safety concerns. No subjects were enrolled into any MAD cohorts.
The total number of unsolicited AE events reported summarized by MedDRA System Organ Class (SOC). If a condition was present at screening it was not considered an AE unless the severity worsened.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1 through Day 30Population: Safety population: All participants that received any amount of study product.
The number of participants who reported at least one SAE. SAEs include any AE that resulted in death, a life-threatening event, an inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or, or a congenital anomaly/birth defect.
Outcome measures
| Measure |
SAD1
n=3 Participants
1 mg (1 injection of 0.1 mL diluted 1:10 in 5% Dextrose Injection, USP) of Rezafungin administered subcutaneously.
|
SAD2
n=6 Participants
10 mg (1 injection of 0.1 mL) of Rezafungin administered subcutaneously.
|
SAD Placebo
n=3 Participants
Placebo participants across all SAD cohorts given matching placebo administered subcutaneously as a single dose in a double-blind manner.
|
MAD4
200 mg (2 injections of 1.0 mL) of Rezafungin administered subcutaneously.
|
MAD Placebo
Placebo participants across all MAD cohorts given matching placebo administered subcutaneously.
|
|---|---|---|---|---|---|
|
Number of Participants With at Least One Severe Adverse Event (SAE) for Single Ascending Dose (SAD)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 through Day 45Population: The study was terminated on 27APR2020 due to safety concerns. No subjects were enrolled into any MAD cohorts.
The number of participants who reported at least one SAE. SAEs include any AE that resulted in death, a life-threatening event, an inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or, or a congenital anomaly/birth defect.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1 through Day 30Population: Safety population: All participants that received any amount of study product.
The number of participants who experienced solicited local reactogenicity events (injection site evaluation), summarized by symptom. Specified solicited events include pain, tenderness, pruritus, ecchymosis, erythema, induration, nodule, ulcer, healed, and scar. Thresholds for measurement grades of solicited local reactogenicity events were considered as ecchymosis \>= 25 mm, erythema \>=25 mm, induration \>=25 mm, nodule \>=25 mm, ulcer \>=1 mm. For functional grades of solicited local reactogenicity events, the threshold for tenderness was considered as discomfort only to the touch or worse. For ecchymosis, erythema, induration, nodule, or ulcer thresholds for functional grade was interference with daily activity or worse, or any measurement over 1mm.
Outcome measures
| Measure |
SAD1
n=3 Participants
1 mg (1 injection of 0.1 mL diluted 1:10 in 5% Dextrose Injection, USP) of Rezafungin administered subcutaneously.
|
SAD2
n=6 Participants
10 mg (1 injection of 0.1 mL) of Rezafungin administered subcutaneously.
|
SAD Placebo
n=3 Participants
Placebo participants across all SAD cohorts given matching placebo administered subcutaneously as a single dose in a double-blind manner.
|
MAD4
200 mg (2 injections of 1.0 mL) of Rezafungin administered subcutaneously.
|
MAD Placebo
Placebo participants across all MAD cohorts given matching placebo administered subcutaneously.
|
|---|---|---|---|---|---|
|
Number of Participants With Solicited Local Reactogenicity Symptom(s) for Single Ascending Dose (SAD)
Any Symptom
|
1 Participants
|
6 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Solicited Local Reactogenicity Symptom(s) for Single Ascending Dose (SAD)
Pain
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Solicited Local Reactogenicity Symptom(s) for Single Ascending Dose (SAD)
Tenderness
|
0 Participants
|
4 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Solicited Local Reactogenicity Symptom(s) for Single Ascending Dose (SAD)
Pruritus
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Solicited Local Reactogenicity Symptom(s) for Single Ascending Dose (SAD)
Ecchymosis, Functional Grade
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Solicited Local Reactogenicity Symptom(s) for Single Ascending Dose (SAD)
Ecchymosis, Measurement Grade
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Solicited Local Reactogenicity Symptom(s) for Single Ascending Dose (SAD)
Induration/Swelling, Functional Grade
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Solicited Local Reactogenicity Symptom(s) for Single Ascending Dose (SAD)
Induration/Swelling, Measurement Grade
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Solicited Local Reactogenicity Symptom(s) for Single Ascending Dose (SAD)
Erythema, Functional Grade
|
0 Participants
|
6 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Solicited Local Reactogenicity Symptom(s) for Single Ascending Dose (SAD)
Erythema, Measurement Grade
|
0 Participants
|
6 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Solicited Local Reactogenicity Symptom(s) for Single Ascending Dose (SAD)
Nodule, Functional Grade
|
0 Participants
|
5 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Solicited Local Reactogenicity Symptom(s) for Single Ascending Dose (SAD)
Nodule, Measurement Grade
|
0 Participants
|
4 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Solicited Local Reactogenicity Symptom(s) for Single Ascending Dose (SAD)
Ulceration, Functional Grade
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Solicited Local Reactogenicity Symptom(s) for Single Ascending Dose (SAD)
Ulceration, Measurement Grade
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 through Day 45Population: The study was terminated on 27APR2020 due to safety concerns. No subjects were enrolled into this cohort.
The number of participants who experienced solicited local reactogenicity events (injection site evaluation), summarized by symptom. Specified solicited events include pain, tenderness, pruritus, ecchymosis, erythema, induration, nodule, ulcer, healed, and scar. Thresholds for measurement grades of solicited local reactogenicity events were considered as ecchymosis \>= 25 mm, erythema \>=25 mm, induration \>=25 mm, nodule \>=25 mm, ulcer \>=1 mm. For functional grades of solicited local reactogenicity events, the threshold for tenderness was considered as discomfort only to the touch or worse. For ecchymosis, erythema, induration, nodule, or ulcer thresholds for functional grade was interference with daily activity or worse, or any measurement over 1mm.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 0 h, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h, 96 h, 144 h, 312 h, and 696 h post-dosePopulation: PK Analysis Subset: All participants who completed one full 10 mg rezafungin dose, as randomized and according to cohort; had at least one post-dose plasma sample with a measurable rezafungin concentration from which at least a subset of the designated PK parameters could be determined; and completed the PK part of the trial without any protocol violations that were likely to affect the PK results.
Mean and standard deviation of rezafungin concentrations in plasma from the SAD 10 mg Dose Group by nominal time point (0 h, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h, 96 h, 144 h, 312 h, 696 h (post-dose)).
Outcome measures
| Measure |
SAD1
n=6 Participants
1 mg (1 injection of 0.1 mL diluted 1:10 in 5% Dextrose Injection, USP) of Rezafungin administered subcutaneously.
|
SAD2
10 mg (1 injection of 0.1 mL) of Rezafungin administered subcutaneously.
|
SAD Placebo
Placebo participants across all SAD cohorts given matching placebo administered subcutaneously as a single dose in a double-blind manner.
|
MAD4
200 mg (2 injections of 1.0 mL) of Rezafungin administered subcutaneously.
|
MAD Placebo
Placebo participants across all MAD cohorts given matching placebo administered subcutaneously.
|
|---|---|---|---|---|---|
|
Rezafungin Concentrations in Plasma, SAD 10 mg Dose Group Concentrations of Rezafungin in Plasma Samples
0 h
|
0 ng/mL
Standard Deviation 0
|
—
|
—
|
—
|
—
|
|
Rezafungin Concentrations in Plasma, SAD 10 mg Dose Group Concentrations of Rezafungin in Plasma Samples
0.5 h
|
0 ng/mL
Standard Deviation 0
|
—
|
—
|
—
|
—
|
|
Rezafungin Concentrations in Plasma, SAD 10 mg Dose Group Concentrations of Rezafungin in Plasma Samples
1 h
|
0 ng/mL
Standard Deviation 0
|
—
|
—
|
—
|
—
|
|
Rezafungin Concentrations in Plasma, SAD 10 mg Dose Group Concentrations of Rezafungin in Plasma Samples
2 h
|
8.983 ng/mL
Standard Deviation 7.386
|
—
|
—
|
—
|
—
|
|
Rezafungin Concentrations in Plasma, SAD 10 mg Dose Group Concentrations of Rezafungin in Plasma Samples
4 h
|
21.5 ng/mL
Standard Deviation 7.954
|
—
|
—
|
—
|
—
|
|
Rezafungin Concentrations in Plasma, SAD 10 mg Dose Group Concentrations of Rezafungin in Plasma Samples
6 h
|
28.68 ng/mL
Standard Deviation 9.949
|
—
|
—
|
—
|
—
|
|
Rezafungin Concentrations in Plasma, SAD 10 mg Dose Group Concentrations of Rezafungin in Plasma Samples
8 h
|
36.35 ng/mL
Standard Deviation 13.62
|
—
|
—
|
—
|
—
|
|
Rezafungin Concentrations in Plasma, SAD 10 mg Dose Group Concentrations of Rezafungin in Plasma Samples
12 h
|
45.9 ng/mL
Standard Deviation 17.56
|
—
|
—
|
—
|
—
|
|
Rezafungin Concentrations in Plasma, SAD 10 mg Dose Group Concentrations of Rezafungin in Plasma Samples
24 h
|
70.87 ng/mL
Standard Deviation 23.52
|
—
|
—
|
—
|
—
|
|
Rezafungin Concentrations in Plasma, SAD 10 mg Dose Group Concentrations of Rezafungin in Plasma Samples
48 h
|
97.75 ng/mL
Standard Deviation 27.35
|
—
|
—
|
—
|
—
|
|
Rezafungin Concentrations in Plasma, SAD 10 mg Dose Group Concentrations of Rezafungin in Plasma Samples
96 h
|
101.8 ng/mL
Standard Deviation 28.3
|
—
|
—
|
—
|
—
|
|
Rezafungin Concentrations in Plasma, SAD 10 mg Dose Group Concentrations of Rezafungin in Plasma Samples
144 h
|
99.9 ng/mL
Standard Deviation 30.15
|
—
|
—
|
—
|
—
|
|
Rezafungin Concentrations in Plasma, SAD 10 mg Dose Group Concentrations of Rezafungin in Plasma Samples
312 h
|
49.5 ng/mL
Standard Deviation 15.06
|
—
|
—
|
—
|
—
|
|
Rezafungin Concentrations in Plasma, SAD 10 mg Dose Group Concentrations of Rezafungin in Plasma Samples
696 h
|
14.52 ng/mL
Standard Deviation 3.594
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 h, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h, 96 h, 144 h, 312 h, and 696 h post-dosePopulation: PK Analysis Subset: All participants who completed one full 10 mg rezafungin dose, as randomized and according to cohort; had at least one post-dose plasma sample with a measurable rezafungin concentration from which at least a subset of the designated PK parameters could be determined; and completed the PK part of the trial without any protocol violations that were likely to affect the PK results.
Mean and standard deviation (SD) of the Cmax (ng/mL) PK parameter estimated from the rezafungin plasma concentration-time data.
Outcome measures
| Measure |
SAD1
n=6 Participants
1 mg (1 injection of 0.1 mL diluted 1:10 in 5% Dextrose Injection, USP) of Rezafungin administered subcutaneously.
|
SAD2
10 mg (1 injection of 0.1 mL) of Rezafungin administered subcutaneously.
|
SAD Placebo
Placebo participants across all SAD cohorts given matching placebo administered subcutaneously as a single dose in a double-blind manner.
|
MAD4
200 mg (2 injections of 1.0 mL) of Rezafungin administered subcutaneously.
|
MAD Placebo
Placebo participants across all MAD cohorts given matching placebo administered subcutaneously.
|
|---|---|---|---|---|---|
|
Rezafungin PK Parameter (Cmax) in Plasma, SAD 10 mg Dose Group
|
108.3 ng/mL
Standard Deviation 29.5
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 h, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h, 96 h, 144 h, 312 h, and 696 h post-dosePopulation: PK Analysis Subset: All participants who completed 10 mg rezafungin dose as randomized; had at least one post-dose plasma sample with a measurable rezafungin concentration from which at least a subset of the designated PK parameters could be determined; and completed the PK part of the trial without any protocol violations that were likely to affect the PK results. t 1/2 was inestimable for all subjects due to not meeting the specified lambda z acceptance criteria.
Mean and standard deviation (SD) of the Tmax (h) and t 1/2 (h) PK parameters were estimated from the rezafungin plasma concentration-time data using Phoenix WinNonlin Non-compartmental Analysis with the following Lambda Z Acceptance Criteria: rsq\_adjusted (adjusted r squared) \>= 0.90, span \>= 3.0 half-lives, and includes at least 3 timepoints after tmax.
Outcome measures
| Measure |
SAD1
n=6 Participants
1 mg (1 injection of 0.1 mL diluted 1:10 in 5% Dextrose Injection, USP) of Rezafungin administered subcutaneously.
|
SAD2
10 mg (1 injection of 0.1 mL) of Rezafungin administered subcutaneously.
|
SAD Placebo
Placebo participants across all SAD cohorts given matching placebo administered subcutaneously as a single dose in a double-blind manner.
|
MAD4
200 mg (2 injections of 1.0 mL) of Rezafungin administered subcutaneously.
|
MAD Placebo
Placebo participants across all MAD cohorts given matching placebo administered subcutaneously.
|
|---|---|---|---|---|---|
|
Rezafungin PK Parameters (Tmax and t 1/2) in Plasma, SAD 10 mg Dose Group
Tmax
|
120 h
Standard Deviation 40.16
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 h, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h, 96 h, 144 h, 312 h, and 696 h post-dosePopulation: PK Analysis Subset: All participants who completed 10 mg rezafungin dose as randomized; had at least one post-dose plasma sample with a measurable rezafungin concentration from which at least a subset of the designated PK parameters could be determined; and completed the PK part of the trial without any protocol violations that were likely to affect the PK results. AUC 0-inf was inestimable for all subjects due to not meeting the specified lambda z acceptance criteria.
Mean and standard deviation (SD) of the AUC 0-last (h\*ng/mL) and AUC 0-inf (h\*ng/mL) PK parameters were estimated from the rezafungin plasma concentration-time data using Phoenix WinNonlin Non-compartmental Analysis with the following Lambda Z Acceptance Criteria: rsq\_adjusted (adjusted r squared) \>= 0.90, span \>= 3.0 half-lives, and includes at least 3 timepoints after tmax.
Outcome measures
| Measure |
SAD1
n=6 Participants
1 mg (1 injection of 0.1 mL diluted 1:10 in 5% Dextrose Injection, USP) of Rezafungin administered subcutaneously.
|
SAD2
10 mg (1 injection of 0.1 mL) of Rezafungin administered subcutaneously.
|
SAD Placebo
Placebo participants across all SAD cohorts given matching placebo administered subcutaneously as a single dose in a double-blind manner.
|
MAD4
200 mg (2 injections of 1.0 mL) of Rezafungin administered subcutaneously.
|
MAD Placebo
Placebo participants across all MAD cohorts given matching placebo administered subcutaneously.
|
|---|---|---|---|---|---|
|
Rezafungin PK Parameters (AUC 0-last and AUC 0-inf ) in Plasma, SAD 10 mg Dose Group
AUC 0-last
|
33950 h*ng/mL
Standard Deviation 9989
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 h, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h, 96 h, 144 h, 312 h, and 696 h post-dosePopulation: PK Analysis Subset: All participants who completed 10 mg rezafungin dose as randomized; had at least one post-dose plasma sample with a measurable rezafungin concentration from which at least a subset of the designated PK parameters could be determined; and completed the PK part of the trial without any protocol violations that were likely to affect the PK results. Lambda z was inestimable for all subjects due to not meeting the specified lambda z acceptance criteria.
Mean and standard deviation (SD) of the lambda z (1/h) PK parameter was estimated from the rezafungin plasma concentration-time data using Phoenix WinNonlin Non-compartmental Analysis with the following Lambda Z Acceptance Criteria: rsq\_adjusted (adjusted r squared) \>= 0.90, span \>= 3.0 half-lives, and includes at least 3 timepoints after tmax.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 0 h, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h, 96 h, 144 h, 312 h, and 696 h post-dosePopulation: PK Analysis Subset: All participants who completed 10 mg rezafungin dose as randomized; had at least one post-dose plasma sample with a measurable rezafungin concentration from which at least a subset of the designated PK parameters could be determined; and completed the PK part of the trial without any protocol violations that were likely to affect the PK results. CL/F was inestimable for all subjects due to not meeting the specified lambda z acceptance criteria.
Mean and standard deviation (SD) of the CL/F (L/h) PK parameter was estimated from the rezafungin plasma concentration-time data using Phoenix WinNonlin Non-compartmental Analysis with the following Lambda Z Acceptance Criteria: rsq\_adjusted (adjusted r squared) \>= 0.90, span \>= 3.0 half-lives, and includes at least 3 timepoints after tmax.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 0 h, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h, 96 h, 144 h, 312 h, and 696 h post-dosePopulation: PK Analysis Subset: All participants who completed 10 mg rezafungin dose as randomized; had at least one post-dose plasma sample with a measurable rezafungin concentration from which at least a subset of the designated PK parameters could be determined; and completed the PK part of the trial without any protocol violations that were likely to affect the PK results. Vz/F was inestimable for all subjects due to not meeting the specified lambda z acceptance criteria.
Mean and standard deviation (SD) of the Vz/F (L) PK parameter was estimated from the rezafungin plasma concentration-time data using Phoenix WinNonlin Non-compartmental Analysis with the following Lambda Z Acceptance Criteria: rsq\_adjusted (adjusted r squared) \>= 0.90, span \>= 3.0 half-lives, and includes at least 3 timepoints after tmax.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1 through Day 45Population: The study was terminated on 27APR2020 due to safety concerns. No subjects were enrolled into any of the MAD cohorts.
Mean and standard deviation of rezafungin concentrations in plasma from the SAD 10 mg Dose Group by nominal time point (0 h, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h, and 12 h on Days 1 and 15, 24 h post-dose on Days 2 and 16, 48 h post-dose on Days 3 and 17; at 1 h and 4 h post-dose on Day 8; at 72 h post-dose on Days 4, 11, and 18; at 96 hours post-dose on Days 5, 12, and 19; at 120 h post-dose on Days 6, 13, and 20; at 144 h post-dose on Days 7, 14, and 21; on Days 30 and 45 post-dose)
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1 through Day 45Population: The study was terminated on 27APR2020 due to safety concerns. No subjects were enrolled into any of the MAD cohorts.
Mean and standard deviation (SD) of PK parameters estimated from the rezafungin plasma concentration-time data. PK Parameters include Cmax (ng/nL), Tmax (h), AUC 0-last (h\*ng/mL), AUC 0-inf (h\*ng/mL), lambda z (1/h), t 1/2 (h), CL/F (L/h), Vz/F (L).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 through Day 52Population: The study was terminated on 27APR2020 due to safety concerns. No subjects were enrolled into any BA cohort.
BA is calculated as the ratio of the area under the curve (AUC) for the subcutaneous (SC) injection to the AUC for the intravenous (IV) infusion, where AUC is assessed by plasma Rezafungin levels. Plasma rezafungin determined by LC-MS/MS methods.
Outcome measures
Outcome data not reported
Adverse Events
SAD1
SAD2
SAD Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SAD1
n=3 participants at risk
1 mg (1 injection of 0.1 ml diluted 1:10 in 5% Dextrose Injection, USP) of Rezafungin administered subcutaneously into the abdomen as a single dose, n=3 (no sentinel dosing) on Day 1 in a double-blind manner.
Randomized 3:1.
|
SAD2
n=6 participants at risk
10 mg (1 injection of 0.1 ml) of Rezafungin administered subcutaneously into the abdomen as a single dose, n=6 (1 sentinel, 5 non-sentinel) on Day 1 in a double-blind manner.
Randomized 3:1.
|
SAD Placebo
n=3 participants at risk
Placebo participants across all SAD cohorts: 1 mg (1 injection of 0.1 ml diluted 1:10 in 5% Dextrose Injection, USP), 10 mg (1 injection of 0.1 ml), 30 mg (1 injection of 0.3 ml)
|
|---|---|---|---|
|
Cardiac disorders
Sinus bradycardia
|
66.7%
2/3 • Number of events 4 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
0.00%
0/6 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
0.00%
0/3 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
|
Investigations
Blood glucose increased
|
33.3%
1/3 • Number of events 1 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
0.00%
0/6 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
0.00%
0/3 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
|
Investigations
Eosinophil count increased
|
33.3%
1/3 • Number of events 1 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
0.00%
0/6 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
0.00%
0/3 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
|
Investigations
Neutrophil count increased
|
33.3%
1/3 • Number of events 2 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
0.00%
0/6 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
0.00%
0/3 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/3 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
16.7%
1/6 • Number of events 1 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
0.00%
0/3 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/3 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
16.7%
1/6 • Number of events 1 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
0.00%
0/3 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
|
General disorders
Injection site discolouration
|
0.00%
0/3 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
16.7%
1/6 • Number of events 1 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
0.00%
0/3 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
|
General disorders
Pain
|
0.00%
0/3 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
16.7%
1/6 • Number of events 1 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
0.00%
0/3 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
33.3%
2/6 • Number of events 2 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
0.00%
0/3 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
|
Investigations
Basophil count increased
|
0.00%
0/3 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
16.7%
1/6 • Number of events 1 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
0.00%
0/3 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
|
Investigations
Blood potassium increased
|
0.00%
0/3 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
16.7%
1/6 • Number of events 1 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
0.00%
0/3 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
|
Investigations
Heart rate decreased
|
0.00%
0/3 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
16.7%
1/6 • Number of events 1 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
0.00%
0/3 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
|
Investigations
Monocyte count increased
|
0.00%
0/3 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
16.7%
1/6 • Number of events 1 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
0.00%
0/3 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
|
Investigations
Prothrombin time shortened
|
0.00%
0/3 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
16.7%
1/6 • Number of events 1 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
0.00%
0/3 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
|
Investigations
White blood cell count increased
|
0.00%
0/3 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
16.7%
1/6 • Number of events 1 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
0.00%
0/3 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
16.7%
1/6 • Number of events 1 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
0.00%
0/3 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
16.7%
1/6 • Number of events 1 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
0.00%
0/3 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
|
Investigations
Blood calcium increased
|
0.00%
0/3 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
0.00%
0/6 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
33.3%
1/3 • Number of events 1 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
0.00%
0/6 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
33.3%
1/3 • Number of events 1 • 30 days: from Day 1 (administration of first dose) to Day 30 (final study visit).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60