Trial Outcomes & Findings for Effect of Inhaled TD-8236 on Allergen-induced Asthmatic Response (NCT NCT04150341)
NCT ID: NCT04150341
Last Updated: 2022-03-18
Results Overview
Values are reported as a weighted mean derived by calculating the AUC change from baseline over the relative time interval, divided by the time interval.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Day 14 of treatment period: 3 to 8 hours after allergen challenge
Results posted on
2022-03-18
Participant Flow
A total of 24 participants were enrolled at 2 sites in the United Kingdom.
Participants were screened with an allergen challenge test within 35 days prior to first dosing. Participants received increasing concentrations of inhaled allergen until a decrease of ≥20% from preallergen forced expiratory volume (in 1 second) (FEV1) was observed during the 30 minutes following the most recent inhalation, and then monitored for a late asthmatic response (LAR).
Participant milestones
| Measure |
TD-8236 150 mcg/TD-8236 1500 mcg/Placebo
Participants received TD-8236 150 mcg first, then TD-8236 1500 mcg, and then Placebo.
All treatment periods were 14 days with a 21 day washout period between treatments.
|
TD-8236 150 mcg/Placebo/TD-8236 1500 mcg
Participants received TD-8236 150 mcg first, then Placebo, and then TD-8236 1500 mcg.
All treatment periods were 14 days with a 21 day washout period between treatments.
|
Placebo/TD-8236 1500 mcg/TD-8236 150 mcg
Participants received Placebo first, then TD-8236 1500 mcg, and then TD-8236 150 mcg.
All treatment periods were 14 days with a 21 day washout period between treatments.
|
Placebo/TD-8236 150 mcg/TD-8236 1500 mcg
Participants received Placebo first, then TD-8236 150 mcg, and then TD-8236 1500 mcg.
All treatment periods were 14 days with a 21 day washout period between treatments.
|
TD-8236 1500 mcg/Placebo/TD-8236 150 mcg
Participants received TD-8236 1500 mcg first, then Placebo, and then TD-8236 150 mcg.
All treatment periods were 14 days with a 21 day washout period between treatments.
|
TD-8236 1500 mcg/TD-8236 150 mcg/Placebo
Participants received TD-8236 1500 mcg first, then TD-8236 150 mcg, and then Placebo.
All treatment periods were 14 days with a 21 day washout period between treatments.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
4
|
4
|
4
|
4
|
|
Overall Study
COMPLETED
|
4
|
4
|
3
|
4
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
TD-8236 150 mcg/TD-8236 1500 mcg/Placebo
Participants received TD-8236 150 mcg first, then TD-8236 1500 mcg, and then Placebo.
All treatment periods were 14 days with a 21 day washout period between treatments.
|
TD-8236 150 mcg/Placebo/TD-8236 1500 mcg
Participants received TD-8236 150 mcg first, then Placebo, and then TD-8236 1500 mcg.
All treatment periods were 14 days with a 21 day washout period between treatments.
|
Placebo/TD-8236 1500 mcg/TD-8236 150 mcg
Participants received Placebo first, then TD-8236 1500 mcg, and then TD-8236 150 mcg.
All treatment periods were 14 days with a 21 day washout period between treatments.
|
Placebo/TD-8236 150 mcg/TD-8236 1500 mcg
Participants received Placebo first, then TD-8236 150 mcg, and then TD-8236 1500 mcg.
All treatment periods were 14 days with a 21 day washout period between treatments.
|
TD-8236 1500 mcg/Placebo/TD-8236 150 mcg
Participants received TD-8236 1500 mcg first, then Placebo, and then TD-8236 150 mcg.
All treatment periods were 14 days with a 21 day washout period between treatments.
|
TD-8236 1500 mcg/TD-8236 150 mcg/Placebo
Participants received TD-8236 1500 mcg first, then TD-8236 150 mcg, and then Placebo.
All treatment periods were 14 days with a 21 day washout period between treatments.
|
|---|---|---|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Effect of Inhaled TD-8236 on Allergen-induced Asthmatic Response
Baseline characteristics by cohort
| Measure |
All Study Participants
n=24 Participants
Participants were randomized to 1 of 6 treatment sequences. Each treatment period was 14 days with a 21 day washout between treatments. All participants were randomized to receive all study drugs.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
42.0 years
STANDARD_DEVIATION 11.21 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 14 of treatment period: 3 to 8 hours after allergen challengePopulation: Only participants with quantifiable measurements are included here.
Values are reported as a weighted mean derived by calculating the AUC change from baseline over the relative time interval, divided by the time interval.
Outcome measures
| Measure |
Placebo
n=22 Participants
Participants were administered inhaled doses of placebo matching TD-8236 once per day (QD) by dry powder inhaler on Day 1 to Day 14 of the 14 day treatment period. An allergen challenge was performed 1 hour after dosing on Day 14 at the dose of allergen required to achieve a successful response at screening.
|
TD-8236 150 mcg
n=22 Participants
Participants were administered 150 microgram (mcg) inhaled doses of TD-8236 once per day (QD) by dry powder inhaler on Day 1 to Day 14 of the 14 day treatment period. An allergen challenge was performed 1 hour after dosing on Day 14 at the dose of allergen required to achieve a successful response at screening.
|
TD-8236 1500 mcg
n=20 Participants
Participants were administered 1500 microgram (mcg) inhaled doses of TD-8236 once per day (QD) by dry powder inhaler on Day 1 to Day 14 of the 14 day treatment period. An allergen challenge was performed 1 hour after dosing on Day 14 at the dose of allergen required to achieve a successful response at screening.
|
|---|---|---|---|
|
Area Under the Curve of Change From Baseline in Forced Expiratory Volume (in 1 Second) (FEV1) From 3 to 8 Hours After Inhaled Allergen Challenge at Day 14
|
-0.53 liters
Standard Error 0.077
|
-0.54 liters
Standard Error 0.077
|
-0.57 liters
Standard Error 0.079
|
SECONDARY outcome
Timeframe: Day 14 of treatment period: 3 to 8 hours after allergen challengePopulation: Only participants with quantifiable measurements are included here.
Values are reported as a weighted mean derived by calculating the AUC percentage change from baseline over the relative time interval, divided by the time interval.
Outcome measures
| Measure |
Placebo
n=20 Participants
Participants were administered inhaled doses of placebo matching TD-8236 once per day (QD) by dry powder inhaler on Day 1 to Day 14 of the 14 day treatment period. An allergen challenge was performed 1 hour after dosing on Day 14 at the dose of allergen required to achieve a successful response at screening.
|
TD-8236 150 mcg
n=22 Participants
Participants were administered 150 microgram (mcg) inhaled doses of TD-8236 once per day (QD) by dry powder inhaler on Day 1 to Day 14 of the 14 day treatment period. An allergen challenge was performed 1 hour after dosing on Day 14 at the dose of allergen required to achieve a successful response at screening.
|
TD-8236 1500 mcg
n=22 Participants
Participants were administered 1500 microgram (mcg) inhaled doses of TD-8236 once per day (QD) by dry powder inhaler on Day 1 to Day 14 of the 14 day treatment period. An allergen challenge was performed 1 hour after dosing on Day 14 at the dose of allergen required to achieve a successful response at screening.
|
|---|---|---|---|
|
Area Under the Curve of Percentage Change From Baseline in Forced Expiratory Volume (in 1 Second) (FEV1) From 3 to 8 Hours After Inhaled Allergen Challenge at Day 14
|
-16.92 percentage change
Standard Error 2.512
|
-17.50 percentage change
Standard Error 2.516
|
-17.97 percentage change
Standard Error 2.562
|
SECONDARY outcome
Timeframe: Day 14 of treatment period: 3 to 8 hours after allergen challengePopulation: Only participants with available data are included.
Outcome measures
| Measure |
Placebo
n=22 Participants
Participants were administered inhaled doses of placebo matching TD-8236 once per day (QD) by dry powder inhaler on Day 1 to Day 14 of the 14 day treatment period. An allergen challenge was performed 1 hour after dosing on Day 14 at the dose of allergen required to achieve a successful response at screening.
|
TD-8236 150 mcg
n=22 Participants
Participants were administered 150 microgram (mcg) inhaled doses of TD-8236 once per day (QD) by dry powder inhaler on Day 1 to Day 14 of the 14 day treatment period. An allergen challenge was performed 1 hour after dosing on Day 14 at the dose of allergen required to achieve a successful response at screening.
|
TD-8236 1500 mcg
n=20 Participants
Participants were administered 1500 microgram (mcg) inhaled doses of TD-8236 once per day (QD) by dry powder inhaler on Day 1 to Day 14 of the 14 day treatment period. An allergen challenge was performed 1 hour after dosing on Day 14 at the dose of allergen required to achieve a successful response at screening.
|
|---|---|---|---|
|
Maximum Decline in Forced Expiratory Volume (in 1 Second) (FEV1) From 3 to 8 Hours After Inhaled Allergen Challenge at Day 14
|
-0.83 liters
Standard Error 0.082
|
-0.86 liters
Standard Error 0.082
|
-0.85 liters
Standard Error 0.084
|
SECONDARY outcome
Timeframe: Day 14 of treatment period: 3 to 8 hours after allergen challengePopulation: Only participants with available data are included.
Outcome measures
| Measure |
Placebo
n=22 Participants
Participants were administered inhaled doses of placebo matching TD-8236 once per day (QD) by dry powder inhaler on Day 1 to Day 14 of the 14 day treatment period. An allergen challenge was performed 1 hour after dosing on Day 14 at the dose of allergen required to achieve a successful response at screening.
|
TD-8236 150 mcg
n=22 Participants
Participants were administered 150 microgram (mcg) inhaled doses of TD-8236 once per day (QD) by dry powder inhaler on Day 1 to Day 14 of the 14 day treatment period. An allergen challenge was performed 1 hour after dosing on Day 14 at the dose of allergen required to achieve a successful response at screening.
|
TD-8236 1500 mcg
n=20 Participants
Participants were administered 1500 microgram (mcg) inhaled doses of TD-8236 once per day (QD) by dry powder inhaler on Day 1 to Day 14 of the 14 day treatment period. An allergen challenge was performed 1 hour after dosing on Day 14 at the dose of allergen required to achieve a successful response at screening.
|
|---|---|---|---|
|
Maximum Percentage Decline in Forced Expiratory Volume (in 1 Second) (FEV1) From 3 to 8 Hours After Inhaled Allergen Challenge at Day 14
|
-27.02 percentage change
Standard Error 2.790
|
-28.18 percentage change
Standard Error 2.794
|
-26.88 percentage change
Standard Error 2.843
|
SECONDARY outcome
Timeframe: Day 14 of treatment period: Pre-dose and 0.5, 1, 2, 4, 6, 8 and 24 hours post-dosePopulation: Only participants with quantifiable measurements are included here.
Outcome measures
| Measure |
Placebo
n=4 Participants
Participants were administered inhaled doses of placebo matching TD-8236 once per day (QD) by dry powder inhaler on Day 1 to Day 14 of the 14 day treatment period. An allergen challenge was performed 1 hour after dosing on Day 14 at the dose of allergen required to achieve a successful response at screening.
|
TD-8236 150 mcg
n=20 Participants
Participants were administered 150 microgram (mcg) inhaled doses of TD-8236 once per day (QD) by dry powder inhaler on Day 1 to Day 14 of the 14 day treatment period. An allergen challenge was performed 1 hour after dosing on Day 14 at the dose of allergen required to achieve a successful response at screening.
|
TD-8236 1500 mcg
Participants were administered 1500 microgram (mcg) inhaled doses of TD-8236 once per day (QD) by dry powder inhaler on Day 1 to Day 14 of the 14 day treatment period. An allergen challenge was performed 1 hour after dosing on Day 14 at the dose of allergen required to achieve a successful response at screening.
|
|---|---|---|---|
|
Area Under the Concentration-time Curve Over One 24-hour Dosing Interval (AUC0-24) of TD-8236 in Plasma
|
0.482 h*ng/mL
Geometric Coefficient of Variation 48.8
|
1.54 h*ng/mL
Geometric Coefficient of Variation 70.6
|
—
|
SECONDARY outcome
Timeframe: Day 14 of treatment period: Pre-dose and 0.5, 1, 2, 4, 6, 8 and 24 hours post-dosePopulation: Only participants with quantifiable measurements are included here.
Outcome measures
| Measure |
Placebo
n=21 Participants
Participants were administered inhaled doses of placebo matching TD-8236 once per day (QD) by dry powder inhaler on Day 1 to Day 14 of the 14 day treatment period. An allergen challenge was performed 1 hour after dosing on Day 14 at the dose of allergen required to achieve a successful response at screening.
|
TD-8236 150 mcg
n=21 Participants
Participants were administered 150 microgram (mcg) inhaled doses of TD-8236 once per day (QD) by dry powder inhaler on Day 1 to Day 14 of the 14 day treatment period. An allergen challenge was performed 1 hour after dosing on Day 14 at the dose of allergen required to achieve a successful response at screening.
|
TD-8236 1500 mcg
Participants were administered 1500 microgram (mcg) inhaled doses of TD-8236 once per day (QD) by dry powder inhaler on Day 1 to Day 14 of the 14 day treatment period. An allergen challenge was performed 1 hour after dosing on Day 14 at the dose of allergen required to achieve a successful response at screening.
|
|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of TD-8236 in Plasma During Dosing Interval
|
0.0207 ng/mL
Geometric Coefficient of Variation 46.4
|
0.160 ng/mL
Geometric Coefficient of Variation 54.3
|
—
|
SECONDARY outcome
Timeframe: Day 14 of treatment period: Pre-dose and 0.5, 1, 2, 4, 6, 8 and 24 hours post-dosePopulation: Only participants with quantifiable measurements are included here.
Outcome measures
| Measure |
Placebo
n=21 Participants
Participants were administered inhaled doses of placebo matching TD-8236 once per day (QD) by dry powder inhaler on Day 1 to Day 14 of the 14 day treatment period. An allergen challenge was performed 1 hour after dosing on Day 14 at the dose of allergen required to achieve a successful response at screening.
|
TD-8236 150 mcg
n=21 Participants
Participants were administered 150 microgram (mcg) inhaled doses of TD-8236 once per day (QD) by dry powder inhaler on Day 1 to Day 14 of the 14 day treatment period. An allergen challenge was performed 1 hour after dosing on Day 14 at the dose of allergen required to achieve a successful response at screening.
|
TD-8236 1500 mcg
Participants were administered 1500 microgram (mcg) inhaled doses of TD-8236 once per day (QD) by dry powder inhaler on Day 1 to Day 14 of the 14 day treatment period. An allergen challenge was performed 1 hour after dosing on Day 14 at the dose of allergen required to achieve a successful response at screening.
|
|---|---|---|---|
|
Time to Maximum Observed Concentration (Tmax) of TD-8236 in Plasma Over a Dosing Interval
|
0.950 hours
Interval 0.483 to 1.03
|
0.550 hours
Interval 0.467 to 1.07
|
—
|
SECONDARY outcome
Timeframe: Day 1 to end of follow-up (up to approximately 98 days)Population: Only participants with available data are included.
A TEAE was defined as any adverse event (AE) that begins on or after the date of first dose of study drug up to the date of last dose of study drug plus the number of days in the follow-up period. The severity of TEAEs were also assessed and were classified as mild, moderate or severe per the definitions below: Mild - The AE is noticeable to the participant and/or the investigator, but does not interfere with routine activity. Moderate - The AE interferes with routine activity, but responds to symptomatic therapy or rest. Severe - The AE significantly limits the participant's ability to perform routine activities despite symptomatic therapy.
Outcome measures
| Measure |
Placebo
n=24 Participants
Participants were administered inhaled doses of placebo matching TD-8236 once per day (QD) by dry powder inhaler on Day 1 to Day 14 of the 14 day treatment period. An allergen challenge was performed 1 hour after dosing on Day 14 at the dose of allergen required to achieve a successful response at screening.
|
TD-8236 150 mcg
n=23 Participants
Participants were administered 150 microgram (mcg) inhaled doses of TD-8236 once per day (QD) by dry powder inhaler on Day 1 to Day 14 of the 14 day treatment period. An allergen challenge was performed 1 hour after dosing on Day 14 at the dose of allergen required to achieve a successful response at screening.
|
TD-8236 1500 mcg
n=24 Participants
Participants were administered 1500 microgram (mcg) inhaled doses of TD-8236 once per day (QD) by dry powder inhaler on Day 1 to Day 14 of the 14 day treatment period. An allergen challenge was performed 1 hour after dosing on Day 14 at the dose of allergen required to achieve a successful response at screening.
|
|---|---|---|---|
|
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
Any TEAE
|
10 Participants
|
9 Participants
|
9 Participants
|
|
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
Moderate or Severe TEAE
|
3 Participants
|
3 Participants
|
2 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
TD-8236 150 mcg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
TD-8236 1500 mcg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=24 participants at risk
Participants were administered inhaled doses of placebo matching TD-8236 once per day (QD) by dry powder inhaler on Day 1 to Day 14 of the 14 day treatment period. An allergen challenge was performed 1 hour after dosing on Day 14 at the dose of allergen required to achieve a successful response at screening.
|
TD-8236 150 mcg
n=23 participants at risk
Participants were administered 150 microgram (mcg) inhaled doses of TD-8236 once per day (QD) by dry powder inhaler on Day 1 to Day 14 of the 14 day treatment period. An allergen challenge was performed 1 hour after dosing on Day 14 at the dose of allergen required to achieve a successful response at screening.
|
TD-8236 1500 mcg
n=24 participants at risk
Participants were administered 1500 microgram (mcg) inhaled doses of TD-8236 once per day (QD) by dry powder inhaler on Day 1 to Day 14 of the 14 day treatment period. An allergen challenge was performed 1 hour after dosing on Day 14 at the dose of allergen required to achieve a successful response at screening.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Exposure to SARS-CoV-2
|
0.00%
0/24 • Day 1 to end of follow-up (up to approximately 98 days)
|
0.00%
0/23 • Day 1 to end of follow-up (up to approximately 98 days)
|
4.2%
1/24 • Number of events 1 • Day 1 to end of follow-up (up to approximately 98 days)
|
|
Injury, poisoning and procedural complications
Injury
|
4.2%
1/24 • Number of events 1 • Day 1 to end of follow-up (up to approximately 98 days)
|
0.00%
0/23 • Day 1 to end of follow-up (up to approximately 98 days)
|
0.00%
0/24 • Day 1 to end of follow-up (up to approximately 98 days)
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
4.2%
1/24 • Number of events 1 • Day 1 to end of follow-up (up to approximately 98 days)
|
0.00%
0/23 • Day 1 to end of follow-up (up to approximately 98 days)
|
0.00%
0/24 • Day 1 to end of follow-up (up to approximately 98 days)
|
|
Injury, poisoning and procedural complications
Joint injury
|
4.2%
1/24 • Number of events 1 • Day 1 to end of follow-up (up to approximately 98 days)
|
0.00%
0/23 • Day 1 to end of follow-up (up to approximately 98 days)
|
0.00%
0/24 • Day 1 to end of follow-up (up to approximately 98 days)
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/24 • Day 1 to end of follow-up (up to approximately 98 days)
|
4.3%
1/23 • Number of events 1 • Day 1 to end of follow-up (up to approximately 98 days)
|
0.00%
0/24 • Day 1 to end of follow-up (up to approximately 98 days)
|
|
Investigations
Liver function test abnormal
|
0.00%
0/24 • Day 1 to end of follow-up (up to approximately 98 days)
|
4.3%
1/23 • Number of events 1 • Day 1 to end of follow-up (up to approximately 98 days)
|
0.00%
0/24 • Day 1 to end of follow-up (up to approximately 98 days)
|
|
Investigations
Forced expiratory volume decreased
|
4.2%
1/24 • Number of events 1 • Day 1 to end of follow-up (up to approximately 98 days)
|
4.3%
1/23 • Number of events 2 • Day 1 to end of follow-up (up to approximately 98 days)
|
0.00%
0/24 • Day 1 to end of follow-up (up to approximately 98 days)
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/24 • Day 1 to end of follow-up (up to approximately 98 days)
|
0.00%
0/23 • Day 1 to end of follow-up (up to approximately 98 days)
|
8.3%
2/24 • Number of events 2 • Day 1 to end of follow-up (up to approximately 98 days)
|
|
Immune system disorders
Seasonal allergy
|
4.2%
1/24 • Number of events 1 • Day 1 to end of follow-up (up to approximately 98 days)
|
4.3%
1/23 • Number of events 1 • Day 1 to end of follow-up (up to approximately 98 days)
|
0.00%
0/24 • Day 1 to end of follow-up (up to approximately 98 days)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.2%
1/24 • Number of events 1 • Day 1 to end of follow-up (up to approximately 98 days)
|
0.00%
0/23 • Day 1 to end of follow-up (up to approximately 98 days)
|
0.00%
0/24 • Day 1 to end of follow-up (up to approximately 98 days)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.2%
1/24 • Number of events 1 • Day 1 to end of follow-up (up to approximately 98 days)
|
0.00%
0/23 • Day 1 to end of follow-up (up to approximately 98 days)
|
0.00%
0/24 • Day 1 to end of follow-up (up to approximately 98 days)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/24 • Day 1 to end of follow-up (up to approximately 98 days)
|
0.00%
0/23 • Day 1 to end of follow-up (up to approximately 98 days)
|
8.3%
2/24 • Number of events 2 • Day 1 to end of follow-up (up to approximately 98 days)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.2%
1/24 • Number of events 1 • Day 1 to end of follow-up (up to approximately 98 days)
|
0.00%
0/23 • Day 1 to end of follow-up (up to approximately 98 days)
|
4.2%
1/24 • Number of events 1 • Day 1 to end of follow-up (up to approximately 98 days)
|
|
Nervous system disorders
Headache
|
4.2%
1/24 • Number of events 1 • Day 1 to end of follow-up (up to approximately 98 days)
|
21.7%
5/23 • Number of events 7 • Day 1 to end of follow-up (up to approximately 98 days)
|
16.7%
4/24 • Number of events 5 • Day 1 to end of follow-up (up to approximately 98 days)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/24 • Day 1 to end of follow-up (up to approximately 98 days)
|
4.3%
1/23 • Number of events 1 • Day 1 to end of follow-up (up to approximately 98 days)
|
0.00%
0/24 • Day 1 to end of follow-up (up to approximately 98 days)
|
|
Eye disorders
Episcleritis
|
0.00%
0/24 • Day 1 to end of follow-up (up to approximately 98 days)
|
4.3%
1/23 • Number of events 1 • Day 1 to end of follow-up (up to approximately 98 days)
|
0.00%
0/24 • Day 1 to end of follow-up (up to approximately 98 days)
|
|
General disorders
Chest discomfort
|
4.2%
1/24 • Number of events 1 • Day 1 to end of follow-up (up to approximately 98 days)
|
4.3%
1/23 • Number of events 1 • Day 1 to end of follow-up (up to approximately 98 days)
|
0.00%
0/24 • Day 1 to end of follow-up (up to approximately 98 days)
|
|
General disorders
Fatigue
|
0.00%
0/24 • Day 1 to end of follow-up (up to approximately 98 days)
|
4.3%
1/23 • Number of events 1 • Day 1 to end of follow-up (up to approximately 98 days)
|
0.00%
0/24 • Day 1 to end of follow-up (up to approximately 98 days)
|
|
General disorders
Pyrexia
|
0.00%
0/24 • Day 1 to end of follow-up (up to approximately 98 days)
|
0.00%
0/23 • Day 1 to end of follow-up (up to approximately 98 days)
|
4.2%
1/24 • Number of events 1 • Day 1 to end of follow-up (up to approximately 98 days)
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/24 • Day 1 to end of follow-up (up to approximately 98 days)
|
4.3%
1/23 • Number of events 1 • Day 1 to end of follow-up (up to approximately 98 days)
|
0.00%
0/24 • Day 1 to end of follow-up (up to approximately 98 days)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/24 • Day 1 to end of follow-up (up to approximately 98 days)
|
4.3%
1/23 • Number of events 1 • Day 1 to end of follow-up (up to approximately 98 days)
|
0.00%
0/24 • Day 1 to end of follow-up (up to approximately 98 days)
|
|
Gastrointestinal disorders
Nausea
|
4.2%
1/24 • Number of events 1 • Day 1 to end of follow-up (up to approximately 98 days)
|
0.00%
0/23 • Day 1 to end of follow-up (up to approximately 98 days)
|
4.2%
1/24 • Number of events 1 • Day 1 to end of follow-up (up to approximately 98 days)
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/24 • Day 1 to end of follow-up (up to approximately 98 days)
|
4.3%
1/23 • Number of events 2 • Day 1 to end of follow-up (up to approximately 98 days)
|
0.00%
0/24 • Day 1 to end of follow-up (up to approximately 98 days)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
4.2%
1/24 • Number of events 1 • Day 1 to end of follow-up (up to approximately 98 days)
|
0.00%
0/23 • Day 1 to end of follow-up (up to approximately 98 days)
|
0.00%
0/24 • Day 1 to end of follow-up (up to approximately 98 days)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.2%
1/24 • Number of events 1 • Day 1 to end of follow-up (up to approximately 98 days)
|
0.00%
0/23 • Day 1 to end of follow-up (up to approximately 98 days)
|
4.2%
1/24 • Number of events 1 • Day 1 to end of follow-up (up to approximately 98 days)
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/24 • Day 1 to end of follow-up (up to approximately 98 days)
|
4.3%
1/23 • Number of events 1 • Day 1 to end of follow-up (up to approximately 98 days)
|
0.00%
0/24 • Day 1 to end of follow-up (up to approximately 98 days)
|
|
Infections and infestations
Lower respiratory tract infection
|
4.2%
1/24 • Number of events 1 • Day 1 to end of follow-up (up to approximately 98 days)
|
0.00%
0/23 • Day 1 to end of follow-up (up to approximately 98 days)
|
0.00%
0/24 • Day 1 to end of follow-up (up to approximately 98 days)
|
|
Infections and infestations
Suspected COVID-19
|
0.00%
0/24 • Day 1 to end of follow-up (up to approximately 98 days)
|
0.00%
0/23 • Day 1 to end of follow-up (up to approximately 98 days)
|
4.2%
1/24 • Number of events 1 • Day 1 to end of follow-up (up to approximately 98 days)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/24 • Day 1 to end of follow-up (up to approximately 98 days)
|
8.7%
2/23 • Number of events 2 • Day 1 to end of follow-up (up to approximately 98 days)
|
4.2%
1/24 • Number of events 1 • Day 1 to end of follow-up (up to approximately 98 days)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place