Trial Outcomes & Findings for A Study to Evaluate Zilucoplan Injected Subcutaneously Either by a Prefilled Syringe or an Auto-injector in Healthy Adult Participants (NCT NCT06511076)
NCT ID: NCT06511076
Last Updated: 2026-01-06
Results Overview
AUC was defined as the area under the plasma concentration-time curve from time zero (predose \[Day 1\]) to infinity for zilucoplan.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
14 participants
Primary outcome timeframe
Baseline (Day 1 of each treatment period at predose) and at predefined time points up to 816 hours (Day 35) postdose
Results posted on
2026-01-06
Participant Flow
The study started to enroll participants in August 2024 and concluded in November 2024.
The Participant Flow refers to the All randomized Study Participants.
Participant milestones
| Measure |
Sequence: Treatment A (ZLP-PFS) - Treatment B (ZLP-AI)
Participants received a single subcutaneous (sc) injection in abdomen using zilucoplan pre-filled syringe (ZLP-PFS) (Treatment A) on Day 1 of Period 1 and a single sc injection in abdomen using zilucoplan auto-injector (ZLP-AI) (Treatment B) on Day 1 of Period 2 in the treatment sequence A-B. Each treatment period was of 35 days and was separated by 7-Days Washout period.
|
Sequence: Treatment B (ZLP-AI) - Treatment A (ZLP-PFS)
Participants received a single sc injection using ZLP-AI (Treatment B) on Day 1 of Period 1 and a single sc injection in abdomen using ZLP-PFS (Treatment A) on Day 1 of Period 2 in the treatment sequence B-A. Each treatment period was of 35 days and was separated by 7-Days Washout period.
|
|---|---|---|
|
Treatment Period 1 (35 Days)
STARTED
|
7
|
7
|
|
Treatment Period 1 (35 Days)
COMPLETED
|
7
|
7
|
|
Treatment Period 1 (35 Days)
NOT COMPLETED
|
0
|
0
|
|
Treatment Period 2 (35 Days)
STARTED
|
7
|
7
|
|
Treatment Period 2 (35 Days)
COMPLETED
|
7
|
7
|
|
Treatment Period 2 (35 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate Zilucoplan Injected Subcutaneously Either by a Prefilled Syringe or an Auto-injector in Healthy Adult Participants
Baseline characteristics by cohort
| Measure |
Sequence: Treatment A (ZLP-PFS) - Treatment B (ZLP-AI)
n=7 Participants
Participants received a single subcutaneous (sc) injection in abdomen using zilucoplan pre-filled syringe (ZLP-PFS) (Treatment A) on Day 1 of Period 1 and a single sc injection in abdomen using zilucoplan auto-injector (ZLP-AI) (Treatment B) on Day 1 of Period 2 in the treatment sequence A-B. Each treatment period was of 35 days and was separated by 7-Days Washout period.
|
Sequence: Treatment B (ZLP-AI) - Treatment A (ZLP-PFS)
n=7 Participants
Participants received a single sc injection using ZLP-AI (Treatment B) on Day 1 of Period 1 and a single sc injection in abdomen using ZLP-PFS (Treatment A) on Day 1 of Period 2 in the treatment sequence B-A. Each treatment period was of 35 days and was separated by 7-Days Washout period.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.0 years
STANDARD_DEVIATION 5.9 • n=37 Participants
|
36.1 years
STANDARD_DEVIATION 15.9 • n=56 Participants
|
30.8 years
STANDARD_DEVIATION 10.0 • n=82 Participants
|
|
Age, Customized
18 - <65 years
|
7 Participants
n=37 Participants
|
7 Participants
n=56 Participants
|
14 Participants
n=82 Participants
|
|
Age, Customized
65 - <85 years
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
|
Age, Customized
>=85 years
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=37 Participants
|
6 Participants
n=56 Participants
|
10 Participants
n=82 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=37 Participants
|
1 Participants
n=56 Participants
|
4 Participants
n=82 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
1 Participants
n=82 Participants
|
|
Race/Ethnicity, Customized
White
|
5 Participants
n=37 Participants
|
7 Participants
n=56 Participants
|
12 Participants
n=82 Participants
|
|
Race/Ethnicity, Customized
Other or Mixed
|
1 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
1 Participants
n=82 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
7 Participants
n=37 Participants
|
7 Participants
n=56 Participants
|
14 Participants
n=82 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1 of each treatment period at predose) and at predefined time points up to 816 hours (Day 35) postdosePopulation: The Pharmacokinetic (PK) Set consisted of all study participants who were randomized, received at least 1 dose of ZLP, and had at least 1 observable PK concentration measurement.
AUC was defined as the area under the plasma concentration-time curve from time zero (predose \[Day 1\]) to infinity for zilucoplan.
Outcome measures
| Measure |
ZLP-PFS
n=14 Participants
Participants received a single sc injection of zilucoplan using pre-filled syringe (ZLP-PFS; Treatment A) on Day 1 of Treatment Period 1 and 2.
|
ZLP-AI
n=14 Participants
Participants received a single sc injection using ZLP-AI (Treatment B) on Day 1 of Treatment Period 1 and 2.
|
|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero (Predose [Day 1]) to Infinity (AUC) for Zilucoplan
|
950930 hour*nanogram per milliliters (h*ng/mL)
Geometric Coefficient of Variation 15.0
|
932740 hour*nanogram per milliliters (h*ng/mL)
Geometric Coefficient of Variation 17.1
|
PRIMARY outcome
Timeframe: Baseline (Day 1 of each treatment period at predose) and at predefined time points up to 816 hours (Day 35) postdosePopulation: The PK Set consisted of all study participants who were randomized, received at least 1 dose of ZLP, and had at least 1 observable PK concentration measurement.
AUC(0-t) was defined as the area under the plasma concentration-time curve from time 0 (predose \[Day 1\]) to the time of the last quantifiable concentration for zilucoplan.
Outcome measures
| Measure |
ZLP-PFS
n=14 Participants
Participants received a single sc injection of zilucoplan using pre-filled syringe (ZLP-PFS; Treatment A) on Day 1 of Treatment Period 1 and 2.
|
ZLP-AI
n=14 Participants
Participants received a single sc injection using ZLP-AI (Treatment B) on Day 1 of Treatment Period 1 and 2.
|
|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time 0 (Predose [Day 1]) to the Time of the Last Quantifiable Concentration (AUC[0-t]) for Zilucoplan
|
921190 h*ng/mL
Geometric Coefficient of Variation 14.5
|
904500 h*ng/mL
Geometric Coefficient of Variation 16.4
|
PRIMARY outcome
Timeframe: Baseline (Day 1 of each treatment period at predose) and at predefined time points up to 816 hours (Day 35) postdosePopulation: The PK Set consisted of all study participants who were randomized, received at least 1 dose of ZLP, and had at least 1 observable PK concentration measurement.
Cmax was defined as the maximum observed plasma concentration for zilucoplan.
Outcome measures
| Measure |
ZLP-PFS
n=14 Participants
Participants received a single sc injection of zilucoplan using pre-filled syringe (ZLP-PFS; Treatment A) on Day 1 of Treatment Period 1 and 2.
|
ZLP-AI
n=14 Participants
Participants received a single sc injection using ZLP-AI (Treatment B) on Day 1 of Treatment Period 1 and 2.
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) for Zilucoplan
|
5599.8 nanograms per milliliters (ng/mL)
Geometric Coefficient of Variation 11.3
|
5597.6 nanograms per milliliters (ng/mL)
Geometric Coefficient of Variation 11.0
|
SECONDARY outcome
Timeframe: From Day 1 to EOS visit or ET visit (up to 82 days)Population: The safety set (SS) consisted of all study participants who were randomized and receive at least 1 dose of ZLP. Study participants were classified according to the sequence to which they were randomly assigned.
An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product, whether or not considered related to the investigational medicinal product. A TEAE was defined as any AE with a start date/time on or after the administration of IMP in each Treatment Period, and up to and including 40 days after the single dose in each Treatment Period (or up to the first dose in Period 2 (for TEAEs following the first dose in Period 1) or last contact date (for TEAEs following the first dose in Period 2) depending on which occurs first. Percentages were displayed to one decimal place and was correspond to whole participant counts due to rounding.
Outcome measures
| Measure |
ZLP-PFS
n=14 Participants
Participants received a single sc injection of zilucoplan using pre-filled syringe (ZLP-PFS; Treatment A) on Day 1 of Treatment Period 1 and 2.
|
ZLP-AI
n=14 Participants
Participants received a single sc injection using ZLP-AI (Treatment B) on Day 1 of Treatment Period 1 and 2.
|
|---|---|---|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) From Day 1 up to the End of Study (EOS) Visit or Early Termination (ET) Visit
|
57.1 percentage of participants
|
57.1 percentage of participants
|
SECONDARY outcome
Timeframe: From Day 1 to EOS visit or ET visit (up to 82 days)Population: The SS consisted of all study participants who were randomized and receive at least 1 dose of ZLP. Study participants were classified according to the sequence to which they were randomly assigned.
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 |
ZLP-PFS
n=14 Participants
Participants received a single sc injection of zilucoplan using pre-filled syringe (ZLP-PFS; Treatment A) on Day 1 of Treatment Period 1 and 2.
|
ZLP-AI
n=14 Participants
Participants received a single sc injection using ZLP-AI (Treatment B) on Day 1 of Treatment Period 1 and 2.
|
|---|---|---|
|
Percentage of Participants With Serious Treatment-emergent Adverse Events (Serious TEAEs) From Day 1 up to the End of Study (EOS) Visit or Early Termination (ET) Visit
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From Day 1 to EOS visit or ET visit (up to 82 days)Population: The SS consisted of all study participants who were randomized and receive at least 1 dose of ZLP. Study participants were classified according to the sequence to which they were randomly assigned.
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. A SADE was defined as an adverse device effect that has resulted in any of the consequences characteristic of a SAE.
Outcome measures
| Measure |
ZLP-PFS
n=14 Participants
Participants received a single sc injection of zilucoplan using pre-filled syringe (ZLP-PFS; Treatment A) on Day 1 of Treatment Period 1 and 2.
|
ZLP-AI
n=14 Participants
Participants received a single sc injection using ZLP-AI (Treatment B) on Day 1 of Treatment Period 1 and 2.
|
|---|---|---|
|
Percentage of Participants With Serious Adverse Device Effects (SADE) From Day 1 up to the End of Study (EOS) Visit or Early Termination (ET) Visit
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From Day 1 to EOS visit or ET visit (up to 82 days)Population: The SS consisted of all study participants who were randomized and receive at least 1 dose of ZLP. Study participants were classified according to the sequence to which they were randomly assigned.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medical device. An ADE was defined as an AE related to the use of an investigational medical device.
Outcome measures
| Measure |
ZLP-PFS
n=14 Participants
Participants received a single sc injection of zilucoplan using pre-filled syringe (ZLP-PFS; Treatment A) on Day 1 of Treatment Period 1 and 2.
|
ZLP-AI
n=14 Participants
Participants received a single sc injection using ZLP-AI (Treatment B) on Day 1 of Treatment Period 1 and 2.
|
|---|---|---|
|
Percentage of Participants With Non-serious Adverse Device Effects (ADE) From Day 1 up to the End of Study (EOS) Visit or Early Termination (ET) Visit
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
ZLP-PFS
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
ZLP-AI
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ZLP-PFS
n=14 participants at risk
Participants received a single sc injection of zilucoplan using pre-filled syringe (ZLP-PFS; Treatment A) on Day 1 of Treatment Period 1 and 2.
|
ZLP-AI
n=14 participants at risk
Participants received a single sc injection using ZLP-AI (Treatment B) on Day 1 of Treatment Period 1 and 2.
|
|---|---|---|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/14 • From Day 1 to EOS visit or ET visit (up to 82 days)
A TEAE was defined as any AE with a start date/time on or after the administration of IMP in each Treatment Period, and up to and including 40 days after the single dose in each Treatment Period (or up to the first dose in Period 2 (for TEAEs following the first dose in Period 1) or last contact date (for TEAEs following the first dose in Period 2) depending on which occurs first.
|
7.1%
1/14 • Number of events 1 • From Day 1 to EOS visit or ET visit (up to 82 days)
A TEAE was defined as any AE with a start date/time on or after the administration of IMP in each Treatment Period, and up to and including 40 days after the single dose in each Treatment Period (or up to the first dose in Period 2 (for TEAEs following the first dose in Period 1) or last contact date (for TEAEs following the first dose in Period 2) depending on which occurs first.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/14 • From Day 1 to EOS visit or ET visit (up to 82 days)
A TEAE was defined as any AE with a start date/time on or after the administration of IMP in each Treatment Period, and up to and including 40 days after the single dose in each Treatment Period (or up to the first dose in Period 2 (for TEAEs following the first dose in Period 1) or last contact date (for TEAEs following the first dose in Period 2) depending on which occurs first.
|
7.1%
1/14 • Number of events 1 • From Day 1 to EOS visit or ET visit (up to 82 days)
A TEAE was defined as any AE with a start date/time on or after the administration of IMP in each Treatment Period, and up to and including 40 days after the single dose in each Treatment Period (or up to the first dose in Period 2 (for TEAEs following the first dose in Period 1) or last contact date (for TEAEs following the first dose in Period 2) depending on which occurs first.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
1/14 • Number of events 1 • From Day 1 to EOS visit or ET visit (up to 82 days)
A TEAE was defined as any AE with a start date/time on or after the administration of IMP in each Treatment Period, and up to and including 40 days after the single dose in each Treatment Period (or up to the first dose in Period 2 (for TEAEs following the first dose in Period 1) or last contact date (for TEAEs following the first dose in Period 2) depending on which occurs first.
|
0.00%
0/14 • From Day 1 to EOS visit or ET visit (up to 82 days)
A TEAE was defined as any AE with a start date/time on or after the administration of IMP in each Treatment Period, and up to and including 40 days after the single dose in each Treatment Period (or up to the first dose in Period 2 (for TEAEs following the first dose in Period 1) or last contact date (for TEAEs following the first dose in Period 2) depending on which occurs first.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
7.1%
1/14 • Number of events 1 • From Day 1 to EOS visit or ET visit (up to 82 days)
A TEAE was defined as any AE with a start date/time on or after the administration of IMP in each Treatment Period, and up to and including 40 days after the single dose in each Treatment Period (or up to the first dose in Period 2 (for TEAEs following the first dose in Period 1) or last contact date (for TEAEs following the first dose in Period 2) depending on which occurs first.
|
0.00%
0/14 • From Day 1 to EOS visit or ET visit (up to 82 days)
A TEAE was defined as any AE with a start date/time on or after the administration of IMP in each Treatment Period, and up to and including 40 days after the single dose in each Treatment Period (or up to the first dose in Period 2 (for TEAEs following the first dose in Period 1) or last contact date (for TEAEs following the first dose in Period 2) depending on which occurs first.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
7.1%
1/14 • Number of events 1 • From Day 1 to EOS visit or ET visit (up to 82 days)
A TEAE was defined as any AE with a start date/time on or after the administration of IMP in each Treatment Period, and up to and including 40 days after the single dose in each Treatment Period (or up to the first dose in Period 2 (for TEAEs following the first dose in Period 1) or last contact date (for TEAEs following the first dose in Period 2) depending on which occurs first.
|
0.00%
0/14 • From Day 1 to EOS visit or ET visit (up to 82 days)
A TEAE was defined as any AE with a start date/time on or after the administration of IMP in each Treatment Period, and up to and including 40 days after the single dose in each Treatment Period (or up to the first dose in Period 2 (for TEAEs following the first dose in Period 1) or last contact date (for TEAEs following the first dose in Period 2) depending on which occurs first.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
7.1%
1/14 • Number of events 1 • From Day 1 to EOS visit or ET visit (up to 82 days)
A TEAE was defined as any AE with a start date/time on or after the administration of IMP in each Treatment Period, and up to and including 40 days after the single dose in each Treatment Period (or up to the first dose in Period 2 (for TEAEs following the first dose in Period 1) or last contact date (for TEAEs following the first dose in Period 2) depending on which occurs first.
|
0.00%
0/14 • From Day 1 to EOS visit or ET visit (up to 82 days)
A TEAE was defined as any AE with a start date/time on or after the administration of IMP in each Treatment Period, and up to and including 40 days after the single dose in each Treatment Period (or up to the first dose in Period 2 (for TEAEs following the first dose in Period 1) or last contact date (for TEAEs following the first dose in Period 2) depending on which occurs first.
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/14 • From Day 1 to EOS visit or ET visit (up to 82 days)
A TEAE was defined as any AE with a start date/time on or after the administration of IMP in each Treatment Period, and up to and including 40 days after the single dose in each Treatment Period (or up to the first dose in Period 2 (for TEAEs following the first dose in Period 1) or last contact date (for TEAEs following the first dose in Period 2) depending on which occurs first.
|
7.1%
1/14 • Number of events 1 • From Day 1 to EOS visit or ET visit (up to 82 days)
A TEAE was defined as any AE with a start date/time on or after the administration of IMP in each Treatment Period, and up to and including 40 days after the single dose in each Treatment Period (or up to the first dose in Period 2 (for TEAEs following the first dose in Period 1) or last contact date (for TEAEs following the first dose in Period 2) depending on which occurs first.
|
|
General disorders
Catheter site papule
|
7.1%
1/14 • Number of events 1 • From Day 1 to EOS visit or ET visit (up to 82 days)
A TEAE was defined as any AE with a start date/time on or after the administration of IMP in each Treatment Period, and up to and including 40 days after the single dose in each Treatment Period (or up to the first dose in Period 2 (for TEAEs following the first dose in Period 1) or last contact date (for TEAEs following the first dose in Period 2) depending on which occurs first.
|
0.00%
0/14 • From Day 1 to EOS visit or ET visit (up to 82 days)
A TEAE was defined as any AE with a start date/time on or after the administration of IMP in each Treatment Period, and up to and including 40 days after the single dose in each Treatment Period (or up to the first dose in Period 2 (for TEAEs following the first dose in Period 1) or last contact date (for TEAEs following the first dose in Period 2) depending on which occurs first.
|
|
General disorders
Catheter site pruritus
|
7.1%
1/14 • Number of events 1 • From Day 1 to EOS visit or ET visit (up to 82 days)
A TEAE was defined as any AE with a start date/time on or after the administration of IMP in each Treatment Period, and up to and including 40 days after the single dose in each Treatment Period (or up to the first dose in Period 2 (for TEAEs following the first dose in Period 1) or last contact date (for TEAEs following the first dose in Period 2) depending on which occurs first.
|
0.00%
0/14 • From Day 1 to EOS visit or ET visit (up to 82 days)
A TEAE was defined as any AE with a start date/time on or after the administration of IMP in each Treatment Period, and up to and including 40 days after the single dose in each Treatment Period (or up to the first dose in Period 2 (for TEAEs following the first dose in Period 1) or last contact date (for TEAEs following the first dose in Period 2) depending on which occurs first.
|
|
General disorders
Catheter site related reaction
|
7.1%
1/14 • Number of events 1 • From Day 1 to EOS visit or ET visit (up to 82 days)
A TEAE was defined as any AE with a start date/time on or after the administration of IMP in each Treatment Period, and up to and including 40 days after the single dose in each Treatment Period (or up to the first dose in Period 2 (for TEAEs following the first dose in Period 1) or last contact date (for TEAEs following the first dose in Period 2) depending on which occurs first.
|
0.00%
0/14 • From Day 1 to EOS visit or ET visit (up to 82 days)
A TEAE was defined as any AE with a start date/time on or after the administration of IMP in each Treatment Period, and up to and including 40 days after the single dose in each Treatment Period (or up to the first dose in Period 2 (for TEAEs following the first dose in Period 1) or last contact date (for TEAEs following the first dose in Period 2) depending on which occurs first.
|
|
General disorders
Catheter site swelling
|
7.1%
1/14 • Number of events 1 • From Day 1 to EOS visit or ET visit (up to 82 days)
A TEAE was defined as any AE with a start date/time on or after the administration of IMP in each Treatment Period, and up to and including 40 days after the single dose in each Treatment Period (or up to the first dose in Period 2 (for TEAEs following the first dose in Period 1) or last contact date (for TEAEs following the first dose in Period 2) depending on which occurs first.
|
0.00%
0/14 • From Day 1 to EOS visit or ET visit (up to 82 days)
A TEAE was defined as any AE with a start date/time on or after the administration of IMP in each Treatment Period, and up to and including 40 days after the single dose in each Treatment Period (or up to the first dose in Period 2 (for TEAEs following the first dose in Period 1) or last contact date (for TEAEs following the first dose in Period 2) depending on which occurs first.
|
|
Infections and infestations
Nasopharyngitis
|
21.4%
3/14 • Number of events 3 • From Day 1 to EOS visit or ET visit (up to 82 days)
A TEAE was defined as any AE with a start date/time on or after the administration of IMP in each Treatment Period, and up to and including 40 days after the single dose in each Treatment Period (or up to the first dose in Period 2 (for TEAEs following the first dose in Period 1) or last contact date (for TEAEs following the first dose in Period 2) depending on which occurs first.
|
35.7%
5/14 • Number of events 5 • From Day 1 to EOS visit or ET visit (up to 82 days)
A TEAE was defined as any AE with a start date/time on or after the administration of IMP in each Treatment Period, and up to and including 40 days after the single dose in each Treatment Period (or up to the first dose in Period 2 (for TEAEs following the first dose in Period 1) or last contact date (for TEAEs following the first dose in Period 2) depending on which occurs first.
|
|
Infections and infestations
Gastroenteritis
|
7.1%
1/14 • Number of events 1 • From Day 1 to EOS visit or ET visit (up to 82 days)
A TEAE was defined as any AE with a start date/time on or after the administration of IMP in each Treatment Period, and up to and including 40 days after the single dose in each Treatment Period (or up to the first dose in Period 2 (for TEAEs following the first dose in Period 1) or last contact date (for TEAEs following the first dose in Period 2) depending on which occurs first.
|
7.1%
1/14 • Number of events 1 • From Day 1 to EOS visit or ET visit (up to 82 days)
A TEAE was defined as any AE with a start date/time on or after the administration of IMP in each Treatment Period, and up to and including 40 days after the single dose in each Treatment Period (or up to the first dose in Period 2 (for TEAEs following the first dose in Period 1) or last contact date (for TEAEs following the first dose in Period 2) depending on which occurs first.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/14 • From Day 1 to EOS visit or ET visit (up to 82 days)
A TEAE was defined as any AE with a start date/time on or after the administration of IMP in each Treatment Period, and up to and including 40 days after the single dose in each Treatment Period (or up to the first dose in Period 2 (for TEAEs following the first dose in Period 1) or last contact date (for TEAEs following the first dose in Period 2) depending on which occurs first.
|
7.1%
1/14 • Number of events 1 • From Day 1 to EOS visit or ET visit (up to 82 days)
A TEAE was defined as any AE with a start date/time on or after the administration of IMP in each Treatment Period, and up to and including 40 days after the single dose in each Treatment Period (or up to the first dose in Period 2 (for TEAEs following the first dose in Period 1) or last contact date (for TEAEs following the first dose in Period 2) depending on which occurs first.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/14 • From Day 1 to EOS visit or ET visit (up to 82 days)
A TEAE was defined as any AE with a start date/time on or after the administration of IMP in each Treatment Period, and up to and including 40 days after the single dose in each Treatment Period (or up to the first dose in Period 2 (for TEAEs following the first dose in Period 1) or last contact date (for TEAEs following the first dose in Period 2) depending on which occurs first.
|
7.1%
1/14 • Number of events 1 • From Day 1 to EOS visit or ET visit (up to 82 days)
A TEAE was defined as any AE with a start date/time on or after the administration of IMP in each Treatment Period, and up to and including 40 days after the single dose in each Treatment Period (or up to the first dose in Period 2 (for TEAEs following the first dose in Period 1) or last contact date (for TEAEs following the first dose in Period 2) depending on which occurs first.
|
|
Infections and infestations
Oral herpes
|
7.1%
1/14 • Number of events 1 • From Day 1 to EOS visit or ET visit (up to 82 days)
A TEAE was defined as any AE with a start date/time on or after the administration of IMP in each Treatment Period, and up to and including 40 days after the single dose in each Treatment Period (or up to the first dose in Period 2 (for TEAEs following the first dose in Period 1) or last contact date (for TEAEs following the first dose in Period 2) depending on which occurs first.
|
0.00%
0/14 • From Day 1 to EOS visit or ET visit (up to 82 days)
A TEAE was defined as any AE with a start date/time on or after the administration of IMP in each Treatment Period, and up to and including 40 days after the single dose in each Treatment Period (or up to the first dose in Period 2 (for TEAEs following the first dose in Period 1) or last contact date (for TEAEs following the first dose in Period 2) depending on which occurs first.
|
|
Injury, poisoning and procedural complications
Contusion
|
7.1%
1/14 • Number of events 1 • From Day 1 to EOS visit or ET visit (up to 82 days)
A TEAE was defined as any AE with a start date/time on or after the administration of IMP in each Treatment Period, and up to and including 40 days after the single dose in each Treatment Period (or up to the first dose in Period 2 (for TEAEs following the first dose in Period 1) or last contact date (for TEAEs following the first dose in Period 2) depending on which occurs first.
|
0.00%
0/14 • From Day 1 to EOS visit or ET visit (up to 82 days)
A TEAE was defined as any AE with a start date/time on or after the administration of IMP in each Treatment Period, and up to and including 40 days after the single dose in each Treatment Period (or up to the first dose in Period 2 (for TEAEs following the first dose in Period 1) or last contact date (for TEAEs following the first dose in Period 2) depending on which occurs first.
|
|
Investigations
Nitrite urine present
|
0.00%
0/14 • From Day 1 to EOS visit or ET visit (up to 82 days)
A TEAE was defined as any AE with a start date/time on or after the administration of IMP in each Treatment Period, and up to and including 40 days after the single dose in each Treatment Period (or up to the first dose in Period 2 (for TEAEs following the first dose in Period 1) or last contact date (for TEAEs following the first dose in Period 2) depending on which occurs first.
|
7.1%
1/14 • Number of events 1 • From Day 1 to EOS visit or ET visit (up to 82 days)
A TEAE was defined as any AE with a start date/time on or after the administration of IMP in each Treatment Period, and up to and including 40 days after the single dose in each Treatment Period (or up to the first dose in Period 2 (for TEAEs following the first dose in Period 1) or last contact date (for TEAEs following the first dose in Period 2) depending on which occurs first.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
1/14 • Number of events 1 • From Day 1 to EOS visit or ET visit (up to 82 days)
A TEAE was defined as any AE with a start date/time on or after the administration of IMP in each Treatment Period, and up to and including 40 days after the single dose in each Treatment Period (or up to the first dose in Period 2 (for TEAEs following the first dose in Period 1) or last contact date (for TEAEs following the first dose in Period 2) depending on which occurs first.
|
0.00%
0/14 • From Day 1 to EOS visit or ET visit (up to 82 days)
A TEAE was defined as any AE with a start date/time on or after the administration of IMP in each Treatment Period, and up to and including 40 days after the single dose in each Treatment Period (or up to the first dose in Period 2 (for TEAEs following the first dose in Period 1) or last contact date (for TEAEs following the first dose in Period 2) depending on which occurs first.
|
|
Nervous system disorders
Headache
|
14.3%
2/14 • Number of events 4 • From Day 1 to EOS visit or ET visit (up to 82 days)
A TEAE was defined as any AE with a start date/time on or after the administration of IMP in each Treatment Period, and up to and including 40 days after the single dose in each Treatment Period (or up to the first dose in Period 2 (for TEAEs following the first dose in Period 1) or last contact date (for TEAEs following the first dose in Period 2) depending on which occurs first.
|
14.3%
2/14 • Number of events 2 • From Day 1 to EOS visit or ET visit (up to 82 days)
A TEAE was defined as any AE with a start date/time on or after the administration of IMP in each Treatment Period, and up to and including 40 days after the single dose in each Treatment Period (or up to the first dose in Period 2 (for TEAEs following the first dose in Period 1) or last contact date (for TEAEs following the first dose in Period 2) depending on which occurs first.
|
|
Nervous system disorders
Dizziness
|
7.1%
1/14 • Number of events 1 • From Day 1 to EOS visit or ET visit (up to 82 days)
A TEAE was defined as any AE with a start date/time on or after the administration of IMP in each Treatment Period, and up to and including 40 days after the single dose in each Treatment Period (or up to the first dose in Period 2 (for TEAEs following the first dose in Period 1) or last contact date (for TEAEs following the first dose in Period 2) depending on which occurs first.
|
7.1%
1/14 • Number of events 1 • From Day 1 to EOS visit or ET visit (up to 82 days)
A TEAE was defined as any AE with a start date/time on or after the administration of IMP in each Treatment Period, and up to and including 40 days after the single dose in each Treatment Period (or up to the first dose in Period 2 (for TEAEs following the first dose in Period 1) or last contact date (for TEAEs following the first dose in Period 2) depending on which occurs first.
|
|
Nervous system disorders
Migraine
|
7.1%
1/14 • Number of events 1 • From Day 1 to EOS visit or ET visit (up to 82 days)
A TEAE was defined as any AE with a start date/time on or after the administration of IMP in each Treatment Period, and up to and including 40 days after the single dose in each Treatment Period (or up to the first dose in Period 2 (for TEAEs following the first dose in Period 1) or last contact date (for TEAEs following the first dose in Period 2) depending on which occurs first.
|
0.00%
0/14 • From Day 1 to EOS visit or ET visit (up to 82 days)
A TEAE was defined as any AE with a start date/time on or after the administration of IMP in each Treatment Period, and up to and including 40 days after the single dose in each Treatment Period (or up to the first dose in Period 2 (for TEAEs following the first dose in Period 1) or last contact date (for TEAEs following the first dose in Period 2) depending on which occurs first.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.1%
1/14 • Number of events 1 • From Day 1 to EOS visit or ET visit (up to 82 days)
A TEAE was defined as any AE with a start date/time on or after the administration of IMP in each Treatment Period, and up to and including 40 days after the single dose in each Treatment Period (or up to the first dose in Period 2 (for TEAEs following the first dose in Period 1) or last contact date (for TEAEs following the first dose in Period 2) depending on which occurs first.
|
0.00%
0/14 • From Day 1 to EOS visit or ET visit (up to 82 days)
A TEAE was defined as any AE with a start date/time on or after the administration of IMP in each Treatment Period, and up to and including 40 days after the single dose in each Treatment Period (or up to the first dose in Period 2 (for TEAEs following the first dose in Period 1) or last contact date (for TEAEs following the first dose in Period 2) depending on which occurs first.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60