Trial Outcomes & Findings for Comparing the Availability of AQ280 in the Body After Single Oral Doses of a Capsule Formulation Versus a Tablet for Oral Suspension Formulation (NCT NCT07093008)
NCT ID: NCT07093008
Last Updated: 2026-06-01
Results Overview
Ratio values were derived based on values for AUC0-Inf of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
9 participants
Primary outcome timeframe
Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
Results posted on
2026-06-01
Participant Flow
Participant milestones
| Measure |
Intervention Sequence 1
Treatment Period 1: Placebo Capsule will be administered orally.
Treatment Period 2: Placebo Tablet for Oral Suspension will be administered orally.
Placebo Capsule: Placebo administered orally in capsule formulation.
Placebo Tablet for Oral Suspension: Placebo administered orally in tablet for oral suspension formulation.
|
Intervention Sequence 2
Treatment Period 1: Placebo Tablet for Oral Suspension will be administered orally.
Treatment Period 2: Placebo Capsule will be administered orally.
Placebo Tablet for Oral Suspension: Placebo administered orally in tablet for oral suspension formulation.
Placebo Capsule: Placebo administered orally in capsule formulation.
|
Intervention Sequence 3
Treatment Period 1: AQ280 Capsule will be administered orally.
Treatment Period 2: AQ280 Tablet for Oral Suspension will be administered orally.
AQ280 Capsule: AQ280 administered orally in capsule formulation.
AQ280 Tablet for Oral Suspension: AQ280 administered orally in tablet for oral suspension formulation.
|
Intervention Sequence 4
Treatment Period 1: AQ280 Tablet for Oral Suspension will be administered orally.
Treatment Period 2: AQ280 Capsule will be administered orally.
AQ280 Tablet for Oral Suspension: AQ280 administered orally in tablet for oral suspension formulation.
AQ280 Capsule: AQ280 administered orally in capsule formulation.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
3
|
3
|
|
Overall Study
COMPLETED
|
1
|
1
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Intervention Sequence 1
Treatment Period 1: Placebo Capsule will be administered orally.
Treatment Period 2: Placebo Tablet for Oral Suspension will be administered orally.
Placebo Capsule: Placebo administered orally in capsule formulation.
Placebo Tablet for Oral Suspension: Placebo administered orally in tablet for oral suspension formulation.
|
Intervention Sequence 2
Treatment Period 1: Placebo Tablet for Oral Suspension will be administered orally.
Treatment Period 2: Placebo Capsule will be administered orally.
Placebo Tablet for Oral Suspension: Placebo administered orally in tablet for oral suspension formulation.
Placebo Capsule: Placebo administered orally in capsule formulation.
|
Intervention Sequence 3
Treatment Period 1: AQ280 Capsule will be administered orally.
Treatment Period 2: AQ280 Tablet for Oral Suspension will be administered orally.
AQ280 Capsule: AQ280 administered orally in capsule formulation.
AQ280 Tablet for Oral Suspension: AQ280 administered orally in tablet for oral suspension formulation.
|
Intervention Sequence 4
Treatment Period 1: AQ280 Tablet for Oral Suspension will be administered orally.
Treatment Period 2: AQ280 Capsule will be administered orally.
AQ280 Tablet for Oral Suspension: AQ280 administered orally in tablet for oral suspension formulation.
AQ280 Capsule: AQ280 administered orally in capsule formulation.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Comparing the Availability of AQ280 in the Body After Single Oral Doses of a Capsule Formulation Versus a Tablet for Oral Suspension Formulation
Baseline characteristics by cohort
| Measure |
Intervention Sequence 1
n=2 Participants
Treatment Period 1: Placebo Capsule will be administered orally.
Treatment Period 2: Placebo Tablet for Oral Suspension will be administered orally.
Placebo Capsule: Placebo administered orally in capsule formulation.
Placebo Tablet for Oral Suspension: Placebo administered orally in tablet for oral suspension formulation.
|
Intervention Sequence 2
n=1 Participants
Treatment Period 1: Placebo Tablet for Oral Suspension will be administered orally.
Treatment Period 2: Placebo Capsule will be administered orally.
Placebo Tablet for Oral Suspension: Placebo administered orally in tablet for oral suspension formulation.
Placebo Capsule: Placebo administered orally in capsule formulation.
|
Intervention Sequence 3
n=3 Participants
Treatment Period 1: AQ280 Capsule will be administered orally.
Treatment Period 2: AQ280 Tablet for Oral Suspension will be administered orally.
AQ280 Capsule: AQ280 administered orally in capsule formulation.
AQ280 Tablet for Oral Suspension: AQ280 administered orally in tablet for oral suspension formulation.
|
Intervention Sequence 4
n=3 Participants
Treatment Period 1: AQ280 Tablet for Oral Suspension will be administered orally.
Treatment Period 2: AQ280 Capsule will be administered orally.
AQ280 Tablet for Oral Suspension: AQ280 administered orally in tablet for oral suspension formulation.
AQ280 Capsule: AQ280 administered orally in capsule formulation.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
41 years
STANDARD_DEVIATION NA • n=24 Participants
|
34 years
STANDARD_DEVIATION NA • n=24 Participants
|
36.3 years
STANDARD_DEVIATION 11.85 • n=48 Participants
|
28.3 years
STANDARD_DEVIATION 7.37 • n=100 Participants
|
34.4 years
STANDARD_DEVIATION 13.22 • n=201 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=24 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=48 Participants
|
3 Participants
n=100 Participants
|
7 Participants
n=201 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=48 Participants
|
0 Participants
n=100 Participants
|
2 Participants
n=201 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=100 Participants
|
1 Participants
n=201 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=24 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=48 Participants
|
3 Participants
n=100 Participants
|
8 Participants
n=201 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=201 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=201 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=48 Participants
|
1 Participants
n=100 Participants
|
2 Participants
n=201 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=201 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=48 Participants
|
0 Participants
n=100 Participants
|
1 Participants
n=201 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=24 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=48 Participants
|
2 Participants
n=100 Participants
|
5 Participants
n=201 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=48 Participants
|
0 Participants
n=100 Participants
|
1 Participants
n=201 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=201 Participants
|
|
Height
|
168.7 cm
STANDARD_DEVIATION NA • n=24 Participants
|
158.6 cm
STANDARD_DEVIATION NA • n=24 Participants
|
160.83 cm
STANDARD_DEVIATION 11.486 • n=48 Participants
|
164.63 cm
STANDARD_DEVIATION 8.578 • n=100 Participants
|
163.60 cm
STANDARD_DEVIATION 8.228 • n=201 Participants
|
|
Body Weight
|
66.15 kg
STANDARD_DEVIATION NA • n=24 Participants
|
59 kg
STANDARD_DEVIATION NA • n=24 Participants
|
64.10 kg
STANDARD_DEVIATION 13.787 • n=48 Participants
|
69.40 kg
STANDARD_DEVIATION 12.401 • n=100 Participants
|
65.76 kg
STANDARD_DEVIATION 9.944 • n=201 Participants
|
|
Body Mass Index
|
23.25 kg/m2
STANDARD_DEVIATION NA • n=24 Participants
|
23.5 kg/m2
STANDARD_DEVIATION NA • n=24 Participants
|
24.83 kg/m2
STANDARD_DEVIATION 5.216 • n=48 Participants
|
25.50 kg/m2
STANDARD_DEVIATION 3.051 • n=100 Participants
|
24.56 kg/m2
STANDARD_DEVIATION 3.174 • n=201 Participants
|
PRIMARY outcome
Timeframe: Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)Population: Pharmacokinetic Analysis Set
Ratio values were derived based on values for AUC0-Inf of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280.
|
AQ280 Capsule
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280. Half of the participants who were randomized to AQ280 received the capsule formulation in Treatment Period 1 followed by the tablet for oral suspension formulation in Treatment Period 2 while the other half received the tablet for oral suspension in Treatment Period 1 followed by the capsule formulation in Treatment Period 2.
|
AQ280 Tablet for Oral Suspension
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280. Half of the participants who were randomized to AQ280 received the capsule formulation in Treatment Period 1 followed by the tablet for oral suspension formulation in Treatment Period 2 while the other half received the tablet for oral suspension in Treatment Period 1 followed by the capsule formulation in Treatment Period 2.
|
|---|---|---|---|
|
Ratio of AUC0-Inf for AQ280 Capsule vs Oral Suspension
|
0.976 Ratio of AUC0-Inf for AQ280 Cap vs Tab
Standard Deviation 0.0377
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)Population: Pharmacokinetic Analysis Set
Ratio values were derived based on values for Cmax of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280.
|
AQ280 Capsule
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280. Half of the participants who were randomized to AQ280 received the capsule formulation in Treatment Period 1 followed by the tablet for oral suspension formulation in Treatment Period 2 while the other half received the tablet for oral suspension in Treatment Period 1 followed by the capsule formulation in Treatment Period 2.
|
AQ280 Tablet for Oral Suspension
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280. Half of the participants who were randomized to AQ280 received the capsule formulation in Treatment Period 1 followed by the tablet for oral suspension formulation in Treatment Period 2 while the other half received the tablet for oral suspension in Treatment Period 1 followed by the capsule formulation in Treatment Period 2.
|
|---|---|---|---|
|
Ratio of Cmax for AQ280 Capsule vs Oral Suspension
|
0.842 Ratio of Cmax for AQ280 Cap vs Tab
Standard Deviation 0.110
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)Population: Pharmacokinetic Analysis Set
AUC0-∞ of relative bioavailability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280.
|
AQ280 Capsule
n=6 Participants
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280. Half of the participants who were randomized to AQ280 received the capsule formulation in Treatment Period 1 followed by the tablet for oral suspension formulation in Treatment Period 2 while the other half received the tablet for oral suspension in Treatment Period 1 followed by the capsule formulation in Treatment Period 2.
|
AQ280 Tablet for Oral Suspension
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280. Half of the participants who were randomized to AQ280 received the capsule formulation in Treatment Period 1 followed by the tablet for oral suspension formulation in Treatment Period 2 while the other half received the tablet for oral suspension in Treatment Period 1 followed by the capsule formulation in Treatment Period 2.
|
|---|---|---|---|
|
Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞)
|
5070 h*ng/mL
Standard Deviation 933
|
4950 h*ng/mL
Standard Deviation 1040
|
—
|
PRIMARY outcome
Timeframe: Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)Population: Pharmacokinetic Analysis Set
AUC0-tlast of relative bioavailability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280.
|
AQ280 Capsule
n=6 Participants
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280. Half of the participants who were randomized to AQ280 received the capsule formulation in Treatment Period 1 followed by the tablet for oral suspension formulation in Treatment Period 2 while the other half received the tablet for oral suspension in Treatment Period 1 followed by the capsule formulation in Treatment Period 2.
|
AQ280 Tablet for Oral Suspension
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280. Half of the participants who were randomized to AQ280 received the capsule formulation in Treatment Period 1 followed by the tablet for oral suspension formulation in Treatment Period 2 while the other half received the tablet for oral suspension in Treatment Period 1 followed by the capsule formulation in Treatment Period 2.
|
|---|---|---|---|
|
Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast)
|
5020 h*ng/mL
Standard Deviation 939
|
4910 h*ng/mL
Standard Deviation 1050
|
—
|
PRIMARY outcome
Timeframe: Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)Population: Pharmacokinetic Analysis Set
Cmax of relative bioavailability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280.
|
AQ280 Capsule
n=6 Participants
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280. Half of the participants who were randomized to AQ280 received the capsule formulation in Treatment Period 1 followed by the tablet for oral suspension formulation in Treatment Period 2 while the other half received the tablet for oral suspension in Treatment Period 1 followed by the capsule formulation in Treatment Period 2.
|
AQ280 Tablet for Oral Suspension
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280. Half of the participants who were randomized to AQ280 received the capsule formulation in Treatment Period 1 followed by the tablet for oral suspension formulation in Treatment Period 2 while the other half received the tablet for oral suspension in Treatment Period 1 followed by the capsule formulation in Treatment Period 2.
|
|---|---|---|---|
|
Maximum Observed Concentration (Cmax)
|
1190 ng/mL
Standard Deviation 413
|
999 ng/mL
Standard Deviation 185
|
—
|
PRIMARY outcome
Timeframe: Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)Population: Pharmacokinetic Analysis Set
Tmax of relative bioavailability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280.
|
AQ280 Capsule
n=6 Participants
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280. Half of the participants who were randomized to AQ280 received the capsule formulation in Treatment Period 1 followed by the tablet for oral suspension formulation in Treatment Period 2 while the other half received the tablet for oral suspension in Treatment Period 1 followed by the capsule formulation in Treatment Period 2.
|
AQ280 Tablet for Oral Suspension
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280. Half of the participants who were randomized to AQ280 received the capsule formulation in Treatment Period 1 followed by the tablet for oral suspension formulation in Treatment Period 2 while the other half received the tablet for oral suspension in Treatment Period 1 followed by the capsule formulation in Treatment Period 2.
|
|---|---|---|---|
|
Time of the Maximum Observed Concentration (Tmax)
|
1.25 h
Standard Deviation 0.523
|
0.911 h
Standard Deviation 0.533
|
—
|
PRIMARY outcome
Timeframe: Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)Population: Pharmacokinetic Analysis Set
T1/2 of relative bioavailability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280.
|
AQ280 Capsule
n=6 Participants
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280. Half of the participants who were randomized to AQ280 received the capsule formulation in Treatment Period 1 followed by the tablet for oral suspension formulation in Treatment Period 2 while the other half received the tablet for oral suspension in Treatment Period 1 followed by the capsule formulation in Treatment Period 2.
|
AQ280 Tablet for Oral Suspension
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280. Half of the participants who were randomized to AQ280 received the capsule formulation in Treatment Period 1 followed by the tablet for oral suspension formulation in Treatment Period 2 while the other half received the tablet for oral suspension in Treatment Period 1 followed by the capsule formulation in Treatment Period 2.
|
|---|---|---|---|
|
Apparent Terminal Elimination Half-life (t1/2)
|
10.8 h
Standard Deviation 3.17
|
8.18 h
Standard Deviation 2.05
|
—
|
PRIMARY outcome
Timeframe: Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)Population: Pharmacokinetic Analysis Set
CL/F of relative bioavailability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280.
|
AQ280 Capsule
n=6 Participants
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280. Half of the participants who were randomized to AQ280 received the capsule formulation in Treatment Period 1 followed by the tablet for oral suspension formulation in Treatment Period 2 while the other half received the tablet for oral suspension in Treatment Period 1 followed by the capsule formulation in Treatment Period 2.
|
AQ280 Tablet for Oral Suspension
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280. Half of the participants who were randomized to AQ280 received the capsule formulation in Treatment Period 1 followed by the tablet for oral suspension formulation in Treatment Period 2 while the other half received the tablet for oral suspension in Treatment Period 1 followed by the capsule formulation in Treatment Period 2.
|
|---|---|---|---|
|
Apparent Total Clearance (CL/F)
|
19.7 L/h
Standard Deviation 4.35
|
20.2 L/h
Standard Deviation 5.05
|
—
|
PRIMARY outcome
Timeframe: Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)Population: Pharmacokinetic Analysis Set
Vz/F of relative bioavailability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280.
|
AQ280 Capsule
n=6 Participants
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280. Half of the participants who were randomized to AQ280 received the capsule formulation in Treatment Period 1 followed by the tablet for oral suspension formulation in Treatment Period 2 while the other half received the tablet for oral suspension in Treatment Period 1 followed by the capsule formulation in Treatment Period 2.
|
AQ280 Tablet for Oral Suspension
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280. Half of the participants who were randomized to AQ280 received the capsule formulation in Treatment Period 1 followed by the tablet for oral suspension formulation in Treatment Period 2 while the other half received the tablet for oral suspension in Treatment Period 1 followed by the capsule formulation in Treatment Period 2.
|
|---|---|---|---|
|
Apparent Volume of Distribution During the Terminal Phase (Vz/F)
|
307 L
Standard Deviation 139
|
239 L
Standard Deviation 97.5
|
—
|
SECONDARY outcome
Timeframe: Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)Population: Safety Analysis Set
Incidence and severity of adverse events to assess the safety and tolerability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280.
|
AQ280 Capsule
n=6 Participants
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280. Half of the participants who were randomized to AQ280 received the capsule formulation in Treatment Period 1 followed by the tablet for oral suspension formulation in Treatment Period 2 while the other half received the tablet for oral suspension in Treatment Period 1 followed by the capsule formulation in Treatment Period 2.
|
AQ280 Tablet for Oral Suspension
n=6 Participants
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280. Half of the participants who were randomized to AQ280 received the capsule formulation in Treatment Period 1 followed by the tablet for oral suspension formulation in Treatment Period 2 while the other half received the tablet for oral suspension in Treatment Period 1 followed by the capsule formulation in Treatment Period 2.
|
|---|---|---|---|
|
Incidence and Severity of Adverse Events
Treatment-emergent adverse events · Mild
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Incidence and Severity of Adverse Events
Treatment-emergent adverse events · No Adverse Event
|
1 Participants
|
6 Participants
|
4 Participants
|
|
Incidence and Severity of Adverse Events
Treatment-related treatment-emergent adverse events · Mild
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Incidence and Severity of Adverse Events
Treatment-related treatment-emergent adverse events · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence and Severity of Adverse Events
Treatment-related treatment-emergent adverse events · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence and Severity of Adverse Events
Treatment-related treatment-emergent adverse events · No Adverse Event
|
2 Participants
|
6 Participants
|
5 Participants
|
|
Incidence and Severity of Adverse Events
Treatment-emergent adverse events · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence and Severity of Adverse Events
Treatment-emergent adverse events · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)Population: Safety Analysis Set
QTcF interval of \>500 msec or change from baseline (Day 1, predose) \>60 msec
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280.
|
AQ280 Capsule
n=6 Participants
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280. Half of the participants who were randomized to AQ280 received the capsule formulation in Treatment Period 1 followed by the tablet for oral suspension formulation in Treatment Period 2 while the other half received the tablet for oral suspension in Treatment Period 1 followed by the capsule formulation in Treatment Period 2.
|
AQ280 Tablet for Oral Suspension
n=6 Participants
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280. Half of the participants who were randomized to AQ280 received the capsule formulation in Treatment Period 1 followed by the tablet for oral suspension formulation in Treatment Period 2 while the other half received the tablet for oral suspension in Treatment Period 1 followed by the capsule formulation in Treatment Period 2.
|
|---|---|---|---|
|
Number of Participants With Abnormal Electrocardiograms
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)Population: Safety Analysis Set
Number of participants with clinically significant abnormalities in vital signs - blood pressure (systolic in mm Hg) to assess the safety and tolerability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280.
|
AQ280 Capsule
n=6 Participants
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280. Half of the participants who were randomized to AQ280 received the capsule formulation in Treatment Period 1 followed by the tablet for oral suspension formulation in Treatment Period 2 while the other half received the tablet for oral suspension in Treatment Period 1 followed by the capsule formulation in Treatment Period 2.
|
AQ280 Tablet for Oral Suspension
n=6 Participants
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280. Half of the participants who were randomized to AQ280 received the capsule formulation in Treatment Period 1 followed by the tablet for oral suspension formulation in Treatment Period 2 while the other half received the tablet for oral suspension in Treatment Period 1 followed by the capsule formulation in Treatment Period 2.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormalities in Vital Signs - Blood Pressure (Systolic in mm Hg)
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)Population: Safety Analysis Set
Number of participants with clinically significant abnormalities in vital signs - blood pressure (diastolic in mm Hg) to assess the safety and tolerability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280.
|
AQ280 Capsule
n=6 Participants
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280. Half of the participants who were randomized to AQ280 received the capsule formulation in Treatment Period 1 followed by the tablet for oral suspension formulation in Treatment Period 2 while the other half received the tablet for oral suspension in Treatment Period 1 followed by the capsule formulation in Treatment Period 2.
|
AQ280 Tablet for Oral Suspension
n=6 Participants
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280. Half of the participants who were randomized to AQ280 received the capsule formulation in Treatment Period 1 followed by the tablet for oral suspension formulation in Treatment Period 2 while the other half received the tablet for oral suspension in Treatment Period 1 followed by the capsule formulation in Treatment Period 2.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormalities in Vital Signs - Blood Pressure (Diastolic in mm Hg)
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)Population: Safety Analysis Set
Number of participants with clinically significant abnormalities in vital signs - pulse rate (beats per minute) to assess the safety and tolerability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280.
|
AQ280 Capsule
n=6 Participants
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280. Half of the participants who were randomized to AQ280 received the capsule formulation in Treatment Period 1 followed by the tablet for oral suspension formulation in Treatment Period 2 while the other half received the tablet for oral suspension in Treatment Period 1 followed by the capsule formulation in Treatment Period 2.
|
AQ280 Tablet for Oral Suspension
n=6 Participants
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280. Half of the participants who were randomized to AQ280 received the capsule formulation in Treatment Period 1 followed by the tablet for oral suspension formulation in Treatment Period 2 while the other half received the tablet for oral suspension in Treatment Period 1 followed by the capsule formulation in Treatment Period 2.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormalities in Vital Signs - Pulse Rate (Beats Per Minute)
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)Population: Safety Analysis Set
Number of participants with clinically significant abnormalities in vital signs - oral body temperature (°C) to assess the safety and tolerability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280.
|
AQ280 Capsule
n=6 Participants
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280. Half of the participants who were randomized to AQ280 received the capsule formulation in Treatment Period 1 followed by the tablet for oral suspension formulation in Treatment Period 2 while the other half received the tablet for oral suspension in Treatment Period 1 followed by the capsule formulation in Treatment Period 2.
|
AQ280 Tablet for Oral Suspension
n=6 Participants
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280. Half of the participants who were randomized to AQ280 received the capsule formulation in Treatment Period 1 followed by the tablet for oral suspension formulation in Treatment Period 2 while the other half received the tablet for oral suspension in Treatment Period 1 followed by the capsule formulation in Treatment Period 2.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormalities in Vital Signs - Oral Body Temperature (°C)
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From screening up to end of study (approximately 7 weeks)Population: Safety Analysis Set
Incidence of abnormal physical examinations to assess the safety and tolerability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation. Any clinically significant findings observed during physical examinations following dose administration were reported as adverse events.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280.
|
AQ280 Capsule
n=6 Participants
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280. Half of the participants who were randomized to AQ280 received the capsule formulation in Treatment Period 1 followed by the tablet for oral suspension formulation in Treatment Period 2 while the other half received the tablet for oral suspension in Treatment Period 1 followed by the capsule formulation in Treatment Period 2.
|
AQ280 Tablet for Oral Suspension
n=6 Participants
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280. Half of the participants who were randomized to AQ280 received the capsule formulation in Treatment Period 1 followed by the tablet for oral suspension formulation in Treatment Period 2 while the other half received the tablet for oral suspension in Treatment Period 1 followed by the capsule formulation in Treatment Period 2.
|
|---|---|---|---|
|
Incidence of Abnormal Physical Examinations
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
AQ280 Capsule
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AQ280 Tablet for Oral Suspension
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=3 participants at risk
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280.
|
AQ280 Capsule
n=6 participants at risk
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280. Half of the participants who were randomized to AQ280 received the capsule formulation in Treatment Period 1 followed by the tablet for oral suspension formulation in Treatment Period 2 while the other half received the tablet for oral suspension in Treatment Period 1 followed by the capsule formulation in Treatment Period 2.
|
AQ280 Tablet for Oral Suspension
n=6 participants at risk
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280. Half of the participants who were randomized to AQ280 received the capsule formulation in Treatment Period 1 followed by the tablet for oral suspension formulation in Treatment Period 2 while the other half received the tablet for oral suspension in Treatment Period 1 followed by the capsule formulation in Treatment Period 2.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
33.3%
1/3 • Number of events 1 • Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
A treatment-emergent adverse event (TEAE) was defined as an adverse event that started during or after dosing or started prior to dosing and increased in severity after dosing. A treatment-related TEAE was defined as a TEAE with a relationship of possibly related, or related to the treatment, as determined by the investigator. All TEAEs considered related to administration of the study intervention are summarized for the safety set.
|
0.00%
0/6 • Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
A treatment-emergent adverse event (TEAE) was defined as an adverse event that started during or after dosing or started prior to dosing and increased in severity after dosing. A treatment-related TEAE was defined as a TEAE with a relationship of possibly related, or related to the treatment, as determined by the investigator. All TEAEs considered related to administration of the study intervention are summarized for the safety set.
|
16.7%
1/6 • Number of events 1 • Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
A treatment-emergent adverse event (TEAE) was defined as an adverse event that started during or after dosing or started prior to dosing and increased in severity after dosing. A treatment-related TEAE was defined as a TEAE with a relationship of possibly related, or related to the treatment, as determined by the investigator. All TEAEs considered related to administration of the study intervention are summarized for the safety set.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
33.3%
1/3 • Number of events 1 • Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
A treatment-emergent adverse event (TEAE) was defined as an adverse event that started during or after dosing or started prior to dosing and increased in severity after dosing. A treatment-related TEAE was defined as a TEAE with a relationship of possibly related, or related to the treatment, as determined by the investigator. All TEAEs considered related to administration of the study intervention are summarized for the safety set.
|
0.00%
0/6 • Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
A treatment-emergent adverse event (TEAE) was defined as an adverse event that started during or after dosing or started prior to dosing and increased in severity after dosing. A treatment-related TEAE was defined as a TEAE with a relationship of possibly related, or related to the treatment, as determined by the investigator. All TEAEs considered related to administration of the study intervention are summarized for the safety set.
|
0.00%
0/6 • Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
A treatment-emergent adverse event (TEAE) was defined as an adverse event that started during or after dosing or started prior to dosing and increased in severity after dosing. A treatment-related TEAE was defined as a TEAE with a relationship of possibly related, or related to the treatment, as determined by the investigator. All TEAEs considered related to administration of the study intervention are summarized for the safety set.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
A treatment-emergent adverse event (TEAE) was defined as an adverse event that started during or after dosing or started prior to dosing and increased in severity after dosing. A treatment-related TEAE was defined as a TEAE with a relationship of possibly related, or related to the treatment, as determined by the investigator. All TEAEs considered related to administration of the study intervention are summarized for the safety set.
|
0.00%
0/6 • Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
A treatment-emergent adverse event (TEAE) was defined as an adverse event that started during or after dosing or started prior to dosing and increased in severity after dosing. A treatment-related TEAE was defined as a TEAE with a relationship of possibly related, or related to the treatment, as determined by the investigator. All TEAEs considered related to administration of the study intervention are summarized for the safety set.
|
0.00%
0/6 • Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
A treatment-emergent adverse event (TEAE) was defined as an adverse event that started during or after dosing or started prior to dosing and increased in severity after dosing. A treatment-related TEAE was defined as a TEAE with a relationship of possibly related, or related to the treatment, as determined by the investigator. All TEAEs considered related to administration of the study intervention are summarized for the safety set.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 1 • Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
A treatment-emergent adverse event (TEAE) was defined as an adverse event that started during or after dosing or started prior to dosing and increased in severity after dosing. A treatment-related TEAE was defined as a TEAE with a relationship of possibly related, or related to the treatment, as determined by the investigator. All TEAEs considered related to administration of the study intervention are summarized for the safety set.
|
0.00%
0/6 • Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
A treatment-emergent adverse event (TEAE) was defined as an adverse event that started during or after dosing or started prior to dosing and increased in severity after dosing. A treatment-related TEAE was defined as a TEAE with a relationship of possibly related, or related to the treatment, as determined by the investigator. All TEAEs considered related to administration of the study intervention are summarized for the safety set.
|
0.00%
0/6 • Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
A treatment-emergent adverse event (TEAE) was defined as an adverse event that started during or after dosing or started prior to dosing and increased in severity after dosing. A treatment-related TEAE was defined as a TEAE with a relationship of possibly related, or related to the treatment, as determined by the investigator. All TEAEs considered related to administration of the study intervention are summarized for the safety set.
|
|
Investigations
Electrocardiogram QT prolonged
|
33.3%
1/3 • Number of events 1 • Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
A treatment-emergent adverse event (TEAE) was defined as an adverse event that started during or after dosing or started prior to dosing and increased in severity after dosing. A treatment-related TEAE was defined as a TEAE with a relationship of possibly related, or related to the treatment, as determined by the investigator. All TEAEs considered related to administration of the study intervention are summarized for the safety set.
|
0.00%
0/6 • Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
A treatment-emergent adverse event (TEAE) was defined as an adverse event that started during or after dosing or started prior to dosing and increased in severity after dosing. A treatment-related TEAE was defined as a TEAE with a relationship of possibly related, or related to the treatment, as determined by the investigator. All TEAEs considered related to administration of the study intervention are summarized for the safety set.
|
0.00%
0/6 • Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
A treatment-emergent adverse event (TEAE) was defined as an adverse event that started during or after dosing or started prior to dosing and increased in severity after dosing. A treatment-related TEAE was defined as a TEAE with a relationship of possibly related, or related to the treatment, as determined by the investigator. All TEAEs considered related to administration of the study intervention are summarized for the safety set.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/3 • Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
A treatment-emergent adverse event (TEAE) was defined as an adverse event that started during or after dosing or started prior to dosing and increased in severity after dosing. A treatment-related TEAE was defined as a TEAE with a relationship of possibly related, or related to the treatment, as determined by the investigator. All TEAEs considered related to administration of the study intervention are summarized for the safety set.
|
0.00%
0/6 • Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
A treatment-emergent adverse event (TEAE) was defined as an adverse event that started during or after dosing or started prior to dosing and increased in severity after dosing. A treatment-related TEAE was defined as a TEAE with a relationship of possibly related, or related to the treatment, as determined by the investigator. All TEAEs considered related to administration of the study intervention are summarized for the safety set.
|
16.7%
1/6 • Number of events 1 • Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
A treatment-emergent adverse event (TEAE) was defined as an adverse event that started during or after dosing or started prior to dosing and increased in severity after dosing. A treatment-related TEAE was defined as a TEAE with a relationship of possibly related, or related to the treatment, as determined by the investigator. All TEAEs considered related to administration of the study intervention are summarized for the safety set.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • Number of events 1 • Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
A treatment-emergent adverse event (TEAE) was defined as an adverse event that started during or after dosing or started prior to dosing and increased in severity after dosing. A treatment-related TEAE was defined as a TEAE with a relationship of possibly related, or related to the treatment, as determined by the investigator. All TEAEs considered related to administration of the study intervention are summarized for the safety set.
|
0.00%
0/6 • Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
A treatment-emergent adverse event (TEAE) was defined as an adverse event that started during or after dosing or started prior to dosing and increased in severity after dosing. A treatment-related TEAE was defined as a TEAE with a relationship of possibly related, or related to the treatment, as determined by the investigator. All TEAEs considered related to administration of the study intervention are summarized for the safety set.
|
0.00%
0/6 • Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
A treatment-emergent adverse event (TEAE) was defined as an adverse event that started during or after dosing or started prior to dosing and increased in severity after dosing. A treatment-related TEAE was defined as a TEAE with a relationship of possibly related, or related to the treatment, as determined by the investigator. All TEAEs considered related to administration of the study intervention are summarized for the safety set.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1 • Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
A treatment-emergent adverse event (TEAE) was defined as an adverse event that started during or after dosing or started prior to dosing and increased in severity after dosing. A treatment-related TEAE was defined as a TEAE with a relationship of possibly related, or related to the treatment, as determined by the investigator. All TEAEs considered related to administration of the study intervention are summarized for the safety set.
|
0.00%
0/6 • Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
A treatment-emergent adverse event (TEAE) was defined as an adverse event that started during or after dosing or started prior to dosing and increased in severity after dosing. A treatment-related TEAE was defined as a TEAE with a relationship of possibly related, or related to the treatment, as determined by the investigator. All TEAEs considered related to administration of the study intervention are summarized for the safety set.
|
0.00%
0/6 • Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
A treatment-emergent adverse event (TEAE) was defined as an adverse event that started during or after dosing or started prior to dosing and increased in severity after dosing. A treatment-related TEAE was defined as a TEAE with a relationship of possibly related, or related to the treatment, as determined by the investigator. All TEAEs considered related to administration of the study intervention are summarized for the safety set.
|
|
Nervous system disorders
Somnolence
|
33.3%
1/3 • Number of events 1 • Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
A treatment-emergent adverse event (TEAE) was defined as an adverse event that started during or after dosing or started prior to dosing and increased in severity after dosing. A treatment-related TEAE was defined as a TEAE with a relationship of possibly related, or related to the treatment, as determined by the investigator. All TEAEs considered related to administration of the study intervention are summarized for the safety set.
|
0.00%
0/6 • Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
A treatment-emergent adverse event (TEAE) was defined as an adverse event that started during or after dosing or started prior to dosing and increased in severity after dosing. A treatment-related TEAE was defined as a TEAE with a relationship of possibly related, or related to the treatment, as determined by the investigator. All TEAEs considered related to administration of the study intervention are summarized for the safety set.
|
0.00%
0/6 • Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
A treatment-emergent adverse event (TEAE) was defined as an adverse event that started during or after dosing or started prior to dosing and increased in severity after dosing. A treatment-related TEAE was defined as a TEAE with a relationship of possibly related, or related to the treatment, as determined by the investigator. All TEAEs considered related to administration of the study intervention are summarized for the safety set.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor Information, Inventions, Results and any other Deliverables are considered Sponsor Confidential Information.
- Publication restrictions are in place
Restriction type: OTHER