Trial Outcomes & Findings for Safety, Tolerability, and Pharmacokinetics of Dapsone in Acne Vulgaris (NCT NCT01773122)
NCT ID: NCT01773122
Last Updated: 2019-04-24
Results Overview
Cmax is the maximum plasma level following multiple doses of dapsone. Plasma is the liquid component of the blood in which the blood cells are suspended.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
77 participants
Primary outcome timeframe
Day 28
Results posted on
2019-04-24
Participant Flow
The protocol was amended mid-study to exclude patients \<16 years.
Participant milestones
| Measure |
Dapsone Formulation A
Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
|
Dapsone Formulation B
Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
|
Dapsone Formulation C
Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
|
Dapsone 5% Gel
Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
19
|
19
|
19
|
|
Overall Study
COMPLETED
|
17
|
18
|
19
|
18
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Dapsone Formulation A
Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
|
Dapsone Formulation B
Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
|
Dapsone Formulation C
Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
|
Dapsone 5% Gel
Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.
|
|---|---|---|---|---|
|
Overall Study
Due to amended age eligibility criteria
|
3
|
1
|
0
|
1
|
Baseline Characteristics
Safety, Tolerability, and Pharmacokinetics of Dapsone in Acne Vulgaris
Baseline characteristics by cohort
| Measure |
Dapsone Formulation A
n=20 Participants
Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
|
Dapsone Formulation B
n=19 Participants
Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
|
Dapsone Formulation C
n=19 Participants
Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
|
Dapsone 5% Gel
n=19 Participants
Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
12 to 17 years
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Age, Customized
18 to 35 years
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 28Population: All treated subjects with data for this time point
Cmax is the maximum plasma level following multiple doses of dapsone. Plasma is the liquid component of the blood in which the blood cells are suspended.
Outcome measures
| Measure |
Dapsone Formulation A
n=17 Participants
Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
|
Dapsone Formulation B
n=18 Participants
Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
|
Dapsone Formulation C
n=19 Participants
Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
|
Dapsone 5% Gel
n=18 Participants
Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.
|
|---|---|---|---|---|
|
Maximum Plasma Level (Cmax) of Dapsone
|
11.7 Nanograms/Milliliter (ng/mL)
Standard Deviation 5.5
|
14.1 Nanograms/Milliliter (ng/mL)
Standard Deviation 8.8
|
13.0 Nanograms/Milliliter (ng/mL)
Standard Deviation 6.8
|
17.6 Nanograms/Milliliter (ng/mL)
Standard Deviation 6.7
|
SECONDARY outcome
Timeframe: Day 28Population: All treated subjects with data for this time point
Cmax is the maximum plasma level following multiple doses of dapsone. Plasma is the liquid component of the blood in which the blood cells are suspended. The dapsone metabolites are N-acetyl dapsone and dapsone hydroxylamine.
Outcome measures
| Measure |
Dapsone Formulation A
n=17 Participants
Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
|
Dapsone Formulation B
n=18 Participants
Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
|
Dapsone Formulation C
n=19 Participants
Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
|
Dapsone 5% Gel
n=18 Participants
Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.
|
|---|---|---|---|---|
|
Maximum Plasma Level (Cmax) of Dapsone Metabolites
N-Acetyl Dapsone
|
5.44 Nanograms/Milliliter (ng/mL)
Standard Deviation 4.25
|
6.00 Nanograms/Milliliter (ng/mL)
Standard Deviation 3.85
|
6.47 Nanograms/Milliliter (ng/mL)
Standard Deviation 5.43
|
11.7 Nanograms/Milliliter (ng/mL)
Standard Deviation 8.8
|
|
Maximum Plasma Level (Cmax) of Dapsone Metabolites
Dapsone Hydroxylamine
|
0.908 Nanograms/Milliliter (ng/mL)
Standard Deviation 0.433
|
1.11 Nanograms/Milliliter (ng/mL)
Standard Deviation 0.46
|
1.19 Nanograms/Milliliter (ng/mL)
Standard Deviation 0.76
|
1.47 Nanograms/Milliliter (ng/mL)
Standard Deviation 0.56
|
Adverse Events
Dapsone Formulation A
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Dapsone Formulation B
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Dapsone Formulation C
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Dapsone 5% Gel
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dapsone Formulation A
n=20 participants at risk
Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
|
Dapsone Formulation B
n=19 participants at risk
Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
|
Dapsone Formulation C
n=19 participants at risk
Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
|
Dapsone 5% Gel
n=19 participants at risk
Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
30.0%
6/20
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
10.5%
2/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
5.3%
1/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
5.3%
1/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
2/20
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
5.3%
1/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
10.5%
2/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
5.3%
1/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Infections and infestations
Pharyngitis
|
10.0%
2/20
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
5.3%
1/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
5.3%
1/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.0%
1/20
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
10.5%
2/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
5.3%
1/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
5.3%
1/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
12.5%
1/8
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
22.2%
2/9
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/10
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
11.1%
1/9
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
1/20
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
5.3%
1/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Injury, poisoning and procedural complications
Excoriation
|
5.0%
1/20
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
5.3%
1/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Injury, poisoning and procedural complications
Laceration
|
5.0%
1/20
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
5.3%
1/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Injury, poisoning and procedural complications
Sunburn
|
5.0%
1/20
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
5.3%
1/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
General disorders
Pyrexia
|
5.0%
1/20
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
5.3%
1/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.0%
1/20
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
General disorders
Medical Device Pain
|
5.0%
1/20
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Infections and infestations
Sinusitis
|
5.0%
1/20
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Infections and infestations
Tinea Versicolour
|
5.0%
1/20
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/20
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
10.5%
2/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/20
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
5.3%
1/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
5.3%
1/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Infections and infestations
Influenza
|
0.00%
0/20
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
5.3%
1/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
5.3%
1/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/20
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
5.3%
1/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/20
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
5.3%
1/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/20
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
5.3%
1/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/20
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
5.3%
1/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Tract Congestion
|
0.00%
0/20
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
5.3%
1/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
General disorders
Influenza Like Illness
|
0.00%
0/20
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
5.3%
1/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/20
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
5.3%
1/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/20
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
5.3%
1/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/20
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
5.3%
1/19
The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER