Trial Outcomes & Findings for A Study to Assess the Bioavailability of a New Tablet Formulation of Minzasolmin and the Effect of Food in Healthy Participants (NCT NCT06533475)
NCT ID: NCT06533475
Last Updated: 2025-11-26
Results Overview
AUC0-t was defined as the area under the plasma concentration-time curve from time zero to the last measurable drug concentration sampling time for Minzasolmin.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
Predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 hour (h) post dose on Day 1, Day 6, and Day 11
Results posted on
2025-11-26
Participant Flow
The study started to enroll participants in September 2024 and concluded in November 2024.
The Participant Flow refers to the Randomized Set.
Participant milestones
| Measure |
Treatment ABC
Participants received minzasolmin granules in capsules, administered under fasting conditions (Treatment A) in Period 1 followed by a single dose of minzasolmin tablet under fasting conditions (Treatment B) in Period 2, further followed by a single dose of minzasolmin tablet under fed conditions (Treatment C) in Period 3. Each treatment period was of 1 Day (Days 1, 6, and 11 respectively) only, separated by 4-Days Washout period.
|
Treatment BCA
Participants received a single dose of minzasolmin tablet under fasting conditions (Treatment B) in Period 1 followed by a single dose of minzasolmin tablet under fed conditions (Treatment C) in Period 2, further followed by minzasolmin granules in capsules, administered under fasting conditions (Treatment A) in Period 3. Each treatment period was of 1 Day (Days 1, 6, and 11 respectively) only, separated by 4-Days Washout period.
|
Treatment CAB
Participants received a single dose of minzasolmin tablet under fed conditions (Treatment C) in Period 1 followed by minzasolmin granules in capsules administered under fasting conditions (Treatment A) in Period 2, further followed by a single dose of minzasolmin tablet under fasting conditions (Treatment B) in Period 3. Each treatment period was of 1 Day (Days 1, 6, and 11 respectively) only, separated by 4-Days Washout period.
|
Treatment ACB
Participants received minzasolmin granules in capsules, administered under fasting conditions (Treatment A) in Period 1 followed by a single dose of minzasolmin tablet under fed conditions (Treatment C) in Period 2, further followed by a single dose of minzasolmin tablet under fasting conditions (Treatment B) in Period 3. Each treatment period was of 1 Day (Days 1, 6, and 11 respectively) only, separated by 4-Days Washout period.
|
Treatment BAC
Participants received a single dose of minzasolmin tablet under fasting conditions (Treatment B) in Period 1 followed by minzasolmin granules in capsules, administered under fasting conditions (Treatment A) in Period 2, further followed by a single dose of minzasolmin tablet under fed conditions (Treatment C) in Period 3. Each treatment period was of 1 Day (Days 1, 6, and 11 respectively) only, separated by 4-Days Washout period.
|
Treatment CBA
Participants received a single dose of minzasolmin tablet (Treatment C) under fed conditions in Period 1 followed by a single dose of minzasolmin tablet (Treatment B) under fasting conditions in Period 2, further followed by minzasolmin granules in capsules (Treatment A), administered under fasting conditions in Period 3. Each treatment period was of 1 Day (Days 1, 6, and 11 respectively) only, separated by 4-Days Washout period.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Assess the Bioavailability of a New Tablet Formulation of Minzasolmin and the Effect of Food in Healthy Participants
Baseline characteristics by cohort
| Measure |
Treatment ABC
n=3 Participants
Participants received minzasolmin granules in capsules, administered under fasting conditions (Treatment A) in Period 1 followed by a single dose of minzasolmin tablet under fasting conditions (Treatment B) in Period 2, further followed by a single dose of minzasolmin tablet under fed conditions (Treatment C) in Period 3. Each treatment period was of 1 Day (Days 1, 6, and 11 respectively) only, separated by 4-Days Washout period.
|
Treatment BCA
n=3 Participants
Participants received a single dose of minzasolmin tablet under fasting conditions (Treatment B) in Period 1 followed by a single dose of minzasolmin tablet under fed conditions (Treatment C) in Period 2, further followed by minzasolmin granules in capsules, administered under fasting conditions (Treatment A) in Period 3. Each treatment period was of 1 Day (Days 1, 6, and 11 respectively) only, separated by 4-Days Washout period.
|
Treatment CAB
n=3 Participants
Participants received a single dose of minzasolmin tablet under fed conditions (Treatment C) in Period 1 followed by minzasolmin granules in capsules administered under fasting conditions (Treatment A) in Period 2, further followed by a single dose of minzasolmin tablet under fasting conditions (Treatment B) in Period 3. Each treatment period was of 1 Day (Days 1, 6, and 11 respectively) only, separated by 4-Days Washout period.
|
Treatment ACB
n=3 Participants
Participants received minzasolmin granules in capsules, administered under fasting conditions (Treatment A) in Period 1 followed by a single dose of minzasolmin tablet under fed conditions (Treatment C) in Period 2, further followed by a single dose of minzasolmin tablet under fasting conditions (Treatment B) in Period 3. Each treatment period was of 1 Day (Days 1, 6, and 11 respectively) only, separated by 4-Days Washout period.
|
Treatment BAC
n=3 Participants
Participants received a single dose of minzasolmin tablet under fasting conditions (Treatment B) in Period 1 followed by minzasolmin granules in capsules, administered under fasting conditions (Treatment A) in Period 2, further followed by a single dose of minzasolmin tablet under fed conditions (Treatment C) in Period 3. Each treatment period was of 1 Day (Days 1, 6, and 11 respectively) only, separated by 4-Days Washout period.
|
Treatment CBA
n=3 Participants
Participants received a single dose of minzasolmin tablet (Treatment C) under fed conditions in Period 1 followed by a single dose of minzasolmin tablet (Treatment B) under fasting conditions in Period 2, further followed by minzasolmin granules in capsules (Treatment A), administered under fasting conditions in Period 3. Each treatment period was of 1 Day (Days 1, 6, and 11 respectively) only, separated by 4-Days Washout period.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
42.0 years
STANDARD_DEVIATION 3.6 • n=9 Participants
|
38.0 years
STANDARD_DEVIATION 6.0 • n=32 Participants
|
44.3 years
STANDARD_DEVIATION 7.1 • n=18 Participants
|
48.0 years
STANDARD_DEVIATION 7.5 • n=78 Participants
|
40.7 years
STANDARD_DEVIATION 8.1 • n=16 Participants
|
43.7 years
STANDARD_DEVIATION 8.1 • n=82 Participants
|
42.8 years
STANDARD_DEVIATION 6.6 • n=13 Participants
|
|
Age, Customized
18 - <65 years
|
3 Participants
n=9 Participants
|
3 Participants
n=32 Participants
|
3 Participants
n=18 Participants
|
3 Participants
n=78 Participants
|
3 Participants
n=16 Participants
|
3 Participants
n=82 Participants
|
18 Participants
n=13 Participants
|
|
Age, Customized
65 - <85 years
|
0 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=13 Participants
|
|
Age, Customized
>=85 years
|
0 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=13 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
1 Participants
n=18 Participants
|
0 Participants
n=78 Participants
|
2 Participants
n=16 Participants
|
3 Participants
n=82 Participants
|
7 Participants
n=13 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=9 Participants
|
3 Participants
n=32 Participants
|
2 Participants
n=18 Participants
|
3 Participants
n=78 Participants
|
1 Participants
n=16 Participants
|
0 Participants
n=82 Participants
|
11 Participants
n=13 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=9 Participants
|
3 Participants
n=32 Participants
|
3 Participants
n=18 Participants
|
3 Participants
n=78 Participants
|
3 Participants
n=16 Participants
|
3 Participants
n=82 Participants
|
18 Participants
n=13 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=78 Participants
|
1 Participants
n=16 Participants
|
0 Participants
n=82 Participants
|
1 Participants
n=13 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
3 Participants
n=9 Participants
|
3 Participants
n=32 Participants
|
3 Participants
n=18 Participants
|
3 Participants
n=78 Participants
|
2 Participants
n=16 Participants
|
3 Participants
n=82 Participants
|
17 Participants
n=13 Participants
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 hour (h) post dose on Day 1, Day 6, and Day 11Population: The Pharmacokinetics (PK) Set consisted of all study participants in the safety set (SS) who had at least 1 observable PK concentration data point and who had no important protocol deviations affecting the PK during the study.
AUC0-t was defined as the area under the plasma concentration-time curve from time zero to the last measurable drug concentration sampling time for Minzasolmin.
Outcome measures
| Measure |
Minzasolmin Capsule (Fasted)
n=18 Participants
All participants who received minzasolmin granules in capsules (Treatment A), administered under fasting conditions in Period 1, 2 and 3. Each treatment period was of 1 Day (Day 1, 6 and 11 respectively) only, separated by 4-Days Washout period.
|
Minzasolmin Tablet (Fasted)
n=18 Participants
All participants who received a single dose of minzasolmin tablet (Treatment B) under fasting conditions in Period 1, 2 and 3. Each treatment period was of 1 Day (Day 1, 6 and 11 respectively) only, separated by 4-Days Washout period.
|
Minzasolmin Tablet (Fed)
n=18 Participants
All participants who received a single dose of minzasolmin tablet (Treatment C) under fed conditions in Period 1, 2 and 3. Each treatment period was of 1 Day (Day 1, 6 and 11 respectively) only, separated by 4-Days Washout period.
|
|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time 0 to t (AUC[0-t]) for Minzasolmin
|
5612 hour*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 34.6
|
5710 hour*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 35.5
|
6140 hour*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 34.2
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 h post dose on Day 1, Day 6, and Day 11Population: The PK set consisted of all study participants in the SS who had at least 1 observable PK concentration data point and who had no important protocol deviations affecting the PK during the study.
AUC was defined as the area under the plasma concentration-time curve from time zero to infinity for Minzasolmin.
Outcome measures
| Measure |
Minzasolmin Capsule (Fasted)
n=18 Participants
All participants who received minzasolmin granules in capsules (Treatment A), administered under fasting conditions in Period 1, 2 and 3. Each treatment period was of 1 Day (Day 1, 6 and 11 respectively) only, separated by 4-Days Washout period.
|
Minzasolmin Tablet (Fasted)
n=18 Participants
All participants who received a single dose of minzasolmin tablet (Treatment B) under fasting conditions in Period 1, 2 and 3. Each treatment period was of 1 Day (Day 1, 6 and 11 respectively) only, separated by 4-Days Washout period.
|
Minzasolmin Tablet (Fed)
n=18 Participants
All participants who received a single dose of minzasolmin tablet (Treatment C) under fed conditions in Period 1, 2 and 3. Each treatment period was of 1 Day (Day 1, 6 and 11 respectively) only, separated by 4-Days Washout period.
|
|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Zero to Infinity for Minzasolmin
|
5656 h*ng/mL
Geometric Coefficient of Variation 34.3
|
5769 h*ng/mL
Geometric Coefficient of Variation 35.5
|
6190 h*ng/mL
Geometric Coefficient of Variation 33.9
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 h post dose on Day 1, Day 6, and Day 11Population: PK set consisted of all study participants in the SS who had at least 1 observable PK concentration data point and who had no important protocol deviations affecting the PK during the study.
Cmax was defined as the maximum (peak) observed drug concentration following a single dose administration of Minzasolmin.
Outcome measures
| Measure |
Minzasolmin Capsule (Fasted)
n=18 Participants
All participants who received minzasolmin granules in capsules (Treatment A), administered under fasting conditions in Period 1, 2 and 3. Each treatment period was of 1 Day (Day 1, 6 and 11 respectively) only, separated by 4-Days Washout period.
|
Minzasolmin Tablet (Fasted)
n=18 Participants
All participants who received a single dose of minzasolmin tablet (Treatment B) under fasting conditions in Period 1, 2 and 3. Each treatment period was of 1 Day (Day 1, 6 and 11 respectively) only, separated by 4-Days Washout period.
|
Minzasolmin Tablet (Fed)
n=18 Participants
All participants who received a single dose of minzasolmin tablet (Treatment C) under fed conditions in Period 1, 2 and 3. Each treatment period was of 1 Day (Day 1, 6 and 11 respectively) only, separated by 4-Days Washout period.
|
|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Minzasolmin
|
627.2 nanograms per mililiter (ng/mL)
Geometric Coefficient of Variation 45.9
|
612.9 nanograms per mililiter (ng/mL)
Geometric Coefficient of Variation 54.8
|
622.5 nanograms per mililiter (ng/mL)
Geometric Coefficient of Variation 30.9
|
SECONDARY outcome
Timeframe: From Baseline to end of Safety Follow-Up, up to 48 daysPopulation: The SS consisted of all study participants who were randomized and received full or partial study medication. Study participants were classified according to the treatment that participants actually received.
An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were all AEs starting on or after the date/time of first treatment and up to including 4 days after last treatment, or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
Outcome measures
| Measure |
Minzasolmin Capsule (Fasted)
n=18 Participants
All participants who received minzasolmin granules in capsules (Treatment A), administered under fasting conditions in Period 1, 2 and 3. Each treatment period was of 1 Day (Day 1, 6 and 11 respectively) only, separated by 4-Days Washout period.
|
Minzasolmin Tablet (Fasted)
n=18 Participants
All participants who received a single dose of minzasolmin tablet (Treatment B) under fasting conditions in Period 1, 2 and 3. Each treatment period was of 1 Day (Day 1, 6 and 11 respectively) only, separated by 4-Days Washout period.
|
Minzasolmin Tablet (Fed)
n=18 Participants
All participants who received a single dose of minzasolmin tablet (Treatment C) under fed conditions in Period 1, 2 and 3. Each treatment period was of 1 Day (Day 1, 6 and 11 respectively) only, separated by 4-Days Washout period.
|
|---|---|---|---|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
|
16.7 percentage of participants
|
22.2 percentage of participants
|
22.2 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline to end of Safety Follow-Up, up to 48 daysPopulation: The SS consisted of all study participants who were randomized and received full or partial study medication. Study participants were classified according to the treatment that participants actually received.
An SAE was defined as any untoward medical occurrence that, at any dose, met 1 or more of the criteria listed: * Results in death * Is life-threatening * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Is a congenital anomaly/birth defect * Important medical events such as (but not limited to) invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias, convulsions not resulting in hospitalization, or development of intervention dependency or intervention abuse.
Outcome measures
| Measure |
Minzasolmin Capsule (Fasted)
n=18 Participants
All participants who received minzasolmin granules in capsules (Treatment A), administered under fasting conditions in Period 1, 2 and 3. Each treatment period was of 1 Day (Day 1, 6 and 11 respectively) only, separated by 4-Days Washout period.
|
Minzasolmin Tablet (Fasted)
n=18 Participants
All participants who received a single dose of minzasolmin tablet (Treatment B) under fasting conditions in Period 1, 2 and 3. Each treatment period was of 1 Day (Day 1, 6 and 11 respectively) only, separated by 4-Days Washout period.
|
Minzasolmin Tablet (Fed)
n=18 Participants
All participants who received a single dose of minzasolmin tablet (Treatment C) under fed conditions in Period 1, 2 and 3. Each treatment period was of 1 Day (Day 1, 6 and 11 respectively) only, separated by 4-Days Washout period.
|
|---|---|---|---|
|
Percentage of Participants With Serious Treatment-emergent Adverse Events (TEAEs)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline to end of Safety Follow-Up, up to 48 daysPopulation: The SS consisted of all study participants who were randomized and received full or partial study medication. Study participants were classified according to the treatment that participants actually received.
An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were all AEs starting on or after the date/time of first treatment and up to including 4 days after last treatment, or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment. Percentage of participants with TEAEs leading to withdrawal from study were reported.
Outcome measures
| Measure |
Minzasolmin Capsule (Fasted)
n=18 Participants
All participants who received minzasolmin granules in capsules (Treatment A), administered under fasting conditions in Period 1, 2 and 3. Each treatment period was of 1 Day (Day 1, 6 and 11 respectively) only, separated by 4-Days Washout period.
|
Minzasolmin Tablet (Fasted)
n=18 Participants
All participants who received a single dose of minzasolmin tablet (Treatment B) under fasting conditions in Period 1, 2 and 3. Each treatment period was of 1 Day (Day 1, 6 and 11 respectively) only, separated by 4-Days Washout period.
|
Minzasolmin Tablet (Fed)
n=18 Participants
All participants who received a single dose of minzasolmin tablet (Treatment C) under fed conditions in Period 1, 2 and 3. Each treatment period was of 1 Day (Day 1, 6 and 11 respectively) only, separated by 4-Days Washout period.
|
|---|---|---|---|
|
Percentage of Participants With TEAEs Leading to Withdrawal From Study
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
Minzasolmin Capsule (Fasted)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Minzasolmin Tablet (Fasted)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Minzasolmin Tablet (Fed)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Minzasolmin Capsule (Fasted)
n=18 participants at risk
All participants who received minzasolmin granules in capsules (Treatment A), administered under fasting conditions in Period 1, 2 and 3. Each treatment period was of 1 Day (Day 1, 6 and 11 respectively) only, separated by 4-Days Washout period.
|
Minzasolmin Tablet (Fasted)
n=18 participants at risk
All participants who received a single dose of minzasolmin tablet (Treatment B) under fasting conditions in Period 1, 2 and 3. Each treatment period was of 1 Day (Day 1, 6 and 11 respectively) only, separated by 4-Days Washout period.
|
Minzasolmin Tablet (Fed)
n=18 participants at risk
All participants who received a single dose of minzasolmin tablet (Treatment C) under fed conditions in Period 1, 2 and 3. Each treatment period was of 1 Day (Day 1, 6 and 11 respectively) only, separated by 4-Days Washout period.
|
|---|---|---|---|
|
Eye disorders
Dry eye
|
5.6%
1/18 • Number of events 1 • From Baseline to end of Safety Follow-Up, up to 48 days
A TEAE was defined all AEs starting on or after the date/time of first treatment and up to including 4 days after last treatment, or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
0.00%
0/18 • From Baseline to end of Safety Follow-Up, up to 48 days
A TEAE was defined all AEs starting on or after the date/time of first treatment and up to including 4 days after last treatment, or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
0.00%
0/18 • From Baseline to end of Safety Follow-Up, up to 48 days
A TEAE was defined all AEs starting on or after the date/time of first treatment and up to including 4 days after last treatment, or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.6%
1/18 • Number of events 1 • From Baseline to end of Safety Follow-Up, up to 48 days
A TEAE was defined all AEs starting on or after the date/time of first treatment and up to including 4 days after last treatment, or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
0.00%
0/18 • From Baseline to end of Safety Follow-Up, up to 48 days
A TEAE was defined all AEs starting on or after the date/time of first treatment and up to including 4 days after last treatment, or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
0.00%
0/18 • From Baseline to end of Safety Follow-Up, up to 48 days
A TEAE was defined all AEs starting on or after the date/time of first treatment and up to including 4 days after last treatment, or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/18 • From Baseline to end of Safety Follow-Up, up to 48 days
A TEAE was defined all AEs starting on or after the date/time of first treatment and up to including 4 days after last treatment, or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
0.00%
0/18 • From Baseline to end of Safety Follow-Up, up to 48 days
A TEAE was defined all AEs starting on or after the date/time of first treatment and up to including 4 days after last treatment, or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
5.6%
1/18 • Number of events 1 • From Baseline to end of Safety Follow-Up, up to 48 days
A TEAE was defined all AEs starting on or after the date/time of first treatment and up to including 4 days after last treatment, or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
5.6%
1/18 • Number of events 1 • From Baseline to end of Safety Follow-Up, up to 48 days
A TEAE was defined all AEs starting on or after the date/time of first treatment and up to including 4 days after last treatment, or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
0.00%
0/18 • From Baseline to end of Safety Follow-Up, up to 48 days
A TEAE was defined all AEs starting on or after the date/time of first treatment and up to including 4 days after last treatment, or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
0.00%
0/18 • From Baseline to end of Safety Follow-Up, up to 48 days
A TEAE was defined all AEs starting on or after the date/time of first treatment and up to including 4 days after last treatment, or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
|
General disorders
Asthenia
|
0.00%
0/18 • From Baseline to end of Safety Follow-Up, up to 48 days
A TEAE was defined all AEs starting on or after the date/time of first treatment and up to including 4 days after last treatment, or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
0.00%
0/18 • From Baseline to end of Safety Follow-Up, up to 48 days
A TEAE was defined all AEs starting on or after the date/time of first treatment and up to including 4 days after last treatment, or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
5.6%
1/18 • Number of events 1 • From Baseline to end of Safety Follow-Up, up to 48 days
A TEAE was defined all AEs starting on or after the date/time of first treatment and up to including 4 days after last treatment, or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
|
Immune system disorders
Allergy to arthropod bite
|
0.00%
0/18 • From Baseline to end of Safety Follow-Up, up to 48 days
A TEAE was defined all AEs starting on or after the date/time of first treatment and up to including 4 days after last treatment, or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
5.6%
1/18 • Number of events 1 • From Baseline to end of Safety Follow-Up, up to 48 days
A TEAE was defined all AEs starting on or after the date/time of first treatment and up to including 4 days after last treatment, or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
0.00%
0/18 • From Baseline to end of Safety Follow-Up, up to 48 days
A TEAE was defined all AEs starting on or after the date/time of first treatment and up to including 4 days after last treatment, or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/18 • From Baseline to end of Safety Follow-Up, up to 48 days
A TEAE was defined all AEs starting on or after the date/time of first treatment and up to including 4 days after last treatment, or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
0.00%
0/18 • From Baseline to end of Safety Follow-Up, up to 48 days
A TEAE was defined all AEs starting on or after the date/time of first treatment and up to including 4 days after last treatment, or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
5.6%
1/18 • Number of events 1 • From Baseline to end of Safety Follow-Up, up to 48 days
A TEAE was defined all AEs starting on or after the date/time of first treatment and up to including 4 days after last treatment, or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
|
Nervous system disorders
Headache
|
5.6%
1/18 • Number of events 1 • From Baseline to end of Safety Follow-Up, up to 48 days
A TEAE was defined all AEs starting on or after the date/time of first treatment and up to including 4 days after last treatment, or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
0.00%
0/18 • From Baseline to end of Safety Follow-Up, up to 48 days
A TEAE was defined all AEs starting on or after the date/time of first treatment and up to including 4 days after last treatment, or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
5.6%
1/18 • Number of events 1 • From Baseline to end of Safety Follow-Up, up to 48 days
A TEAE was defined all AEs starting on or after the date/time of first treatment and up to including 4 days after last treatment, or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
|
Nervous system disorders
Dizziness postural
|
5.6%
1/18 • Number of events 1 • From Baseline to end of Safety Follow-Up, up to 48 days
A TEAE was defined all AEs starting on or after the date/time of first treatment and up to including 4 days after last treatment, or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
0.00%
0/18 • From Baseline to end of Safety Follow-Up, up to 48 days
A TEAE was defined all AEs starting on or after the date/time of first treatment and up to including 4 days after last treatment, or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
5.6%
1/18 • Number of events 1 • From Baseline to end of Safety Follow-Up, up to 48 days
A TEAE was defined all AEs starting on or after the date/time of first treatment and up to including 4 days after last treatment, or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/18 • From Baseline to end of Safety Follow-Up, up to 48 days
A TEAE was defined all AEs starting on or after the date/time of first treatment and up to including 4 days after last treatment, or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
5.6%
1/18 • Number of events 1 • From Baseline to end of Safety Follow-Up, up to 48 days
A TEAE was defined all AEs starting on or after the date/time of first treatment and up to including 4 days after last treatment, or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
5.6%
1/18 • Number of events 1 • From Baseline to end of Safety Follow-Up, up to 48 days
A TEAE was defined all AEs starting on or after the date/time of first treatment and up to including 4 days after last treatment, or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/18 • From Baseline to end of Safety Follow-Up, up to 48 days
A TEAE was defined all AEs starting on or after the date/time of first treatment and up to including 4 days after last treatment, or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
5.6%
1/18 • Number of events 1 • From Baseline to end of Safety Follow-Up, up to 48 days
A TEAE was defined all AEs starting on or after the date/time of first treatment and up to including 4 days after last treatment, or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
0.00%
0/18 • From Baseline to end of Safety Follow-Up, up to 48 days
A TEAE was defined all AEs starting on or after the date/time of first treatment and up to including 4 days after last treatment, or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
|
Vascular disorders
Haematoma
|
0.00%
0/18 • From Baseline to end of Safety Follow-Up, up to 48 days
A TEAE was defined all AEs starting on or after the date/time of first treatment and up to including 4 days after last treatment, or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
5.6%
1/18 • Number of events 1 • From Baseline to end of Safety Follow-Up, up to 48 days
A TEAE was defined all AEs starting on or after the date/time of first treatment and up to including 4 days after last treatment, or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
0.00%
0/18 • From Baseline to end of Safety Follow-Up, up to 48 days
A TEAE was defined all AEs starting on or after the date/time of first treatment and up to including 4 days after last treatment, or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
|
Vascular disorders
Hot flush
|
0.00%
0/18 • From Baseline to end of Safety Follow-Up, up to 48 days
A TEAE was defined all AEs starting on or after the date/time of first treatment and up to including 4 days after last treatment, or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
0.00%
0/18 • From Baseline to end of Safety Follow-Up, up to 48 days
A TEAE was defined all AEs starting on or after the date/time of first treatment and up to including 4 days after last treatment, or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
5.6%
1/18 • Number of events 1 • From Baseline to end of Safety Follow-Up, up to 48 days
A TEAE was defined all AEs starting on or after the date/time of first treatment and up to including 4 days after last treatment, or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60