Trial Outcomes & Findings for Study of Lanadelumab in Healthy Japanese and Matched Caucasian Adult Subjects (NCT NCT03401671)
NCT ID: NCT03401671
Last Updated: 2021-06-03
Results Overview
Cmax is the maximum observed plasma concentration of Lanadelumab was presented. Geometric mean and geometric coefficient of variation percent (CV%) was presented.
COMPLETED
PHASE1
32 participants
Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dose
2021-06-03
Participant Flow
The study was conducted in the United States between 15 January 2018 (first participant first visit) and 30 May 2018 (last participant last visit).
A total of 32 participants were enrolled, received the treatment and completed the study.
Participant milestones
| Measure |
Japanese
Healthy participants of Japanese descent received a single dose of 300 milligrams (mg) lanadelumab subcutaneous (SC) injection in the abdomen.
|
Non-Hispanic Caucasians
Healthy Non-Hispanic Caucasian participants received a single dose of 300 mg lanadelumab SC injection in the abdomen.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
|
Overall Study
COMPLETED
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Lanadelumab in Healthy Japanese and Matched Caucasian Adult Subjects
Baseline characteristics by cohort
| Measure |
Japanese
n=16 Participants
Healthy participants of Japanese descent received a single dose of 300 mg lanadelumab SC injection in the abdomen.
|
Non-Hispanic Caucasians
n=16 Participants
Healthy Non-Hispanic Caucasian participants received a single dose of 300 mg lanadelumab SC injection in the abdomen.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.4 Years
STANDARD_DEVIATION 7.82 • n=99 Participants
|
42.8 Years
STANDARD_DEVIATION 6.40 • n=107 Participants
|
43.1 Years
STANDARD_DEVIATION 7.04 • n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
16 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dosePopulation: Pharmacokinetic (PK) set consisted of all participants who received at least 1 dose of lanadelumab and had at least 1 evaluable post-dose PK concentration value.
Cmax is the maximum observed plasma concentration of Lanadelumab was presented. Geometric mean and geometric coefficient of variation percent (CV%) was presented.
Outcome measures
| Measure |
Japanese
n=16 Participants
Healthy participants of Japanese descent received a single dose of 300 mg lanadelumab SC injection in the abdomen.
|
Non-Hispanic Caucasians
n=16 Participants
Healthy Non-Hispanic Caucasian participants received a single dose of 300 mg lanadelumab SC injection in the abdomen.
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Lanadelumab
|
21.91 microgram per milliliter (ug/mL)
Geometric Coefficient of Variation 38
|
21.42 microgram per milliliter (ug/mL)
Geometric Coefficient of Variation 25
|
PRIMARY outcome
Timeframe: Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dosePopulation: PK set consisted of all participants who received at least 1 dose of lanadelumab and had at least 1 evaluable post-dose PK concentration value.
Tmax of Lanadelumab was presented.
Outcome measures
| Measure |
Japanese
n=16 Participants
Healthy participants of Japanese descent received a single dose of 300 mg lanadelumab SC injection in the abdomen.
|
Non-Hispanic Caucasians
n=16 Participants
Healthy Non-Hispanic Caucasian participants received a single dose of 300 mg lanadelumab SC injection in the abdomen.
|
|---|---|---|
|
Time to Reach Maximum Observed Drug Concentration in Plasma (Tmax) of Lanadelumab
|
5.67 day
Interval 2.0 to 6.11
|
5.00 day
Interval 3.0 to 13.0
|
PRIMARY outcome
Timeframe: Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dosePopulation: PK set consisted of all participants who received at least 1 dose of lanadelumab and had at least 1 evaluable post-dose PK concentration value.
AUC(0-last) of Lanadelumab was presented. Geometric mean and geometric coefficient of variation percent (CV%) was presented.
Outcome measures
| Measure |
Japanese
n=16 Participants
Healthy participants of Japanese descent received a single dose of 300 mg lanadelumab SC injection in the abdomen.
|
Non-Hispanic Caucasians
n=16 Participants
Healthy Non-Hispanic Caucasian participants received a single dose of 300 mg lanadelumab SC injection in the abdomen.
|
|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) in Plasma of Lanadelumab
|
510.6 day*microgram per milliliter(day*ug/mL)
Geometric Coefficient of Variation 30
|
547.6 day*microgram per milliliter(day*ug/mL)
Geometric Coefficient of Variation 20
|
PRIMARY outcome
Timeframe: Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dosePopulation: PK set consisted of all participants who received at least 1 dose of lanadelumab and had at least 1 evaluable post-dose PK concentration value.
AUC(0-infinity) of Lanadelumab was presented.Geometric mean and geometric coefficient of variation percent (CV%) was presented.
Outcome measures
| Measure |
Japanese
n=16 Participants
Healthy participants of Japanese descent received a single dose of 300 mg lanadelumab SC injection in the abdomen.
|
Non-Hispanic Caucasians
n=16 Participants
Healthy Non-Hispanic Caucasian participants received a single dose of 300 mg lanadelumab SC injection in the abdomen.
|
|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Lanadelumab
|
515.0 day*microgram per milliliter(day* ug/mL)
Geometric Coefficient of Variation 30
|
552.7 day*microgram per milliliter(day* ug/mL)
Geometric Coefficient of Variation 20
|
PRIMARY outcome
Timeframe: Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dosePopulation: PK set consisted of all participants who received at least 1 dose of lanadelumab and had at least 1 evaluable post-dose PK concentration value.
Lambda z of Lanadelumab was presented.Geometric mean and geometric coefficient of variation percent (CV%) was presented.
Outcome measures
| Measure |
Japanese
n=16 Participants
Healthy participants of Japanese descent received a single dose of 300 mg lanadelumab SC injection in the abdomen.
|
Non-Hispanic Caucasians
n=16 Participants
Healthy Non-Hispanic Caucasian participants received a single dose of 300 mg lanadelumab SC injection in the abdomen.
|
|---|---|---|
|
Terminal Elimination Rate Constant (Lambda z) for Lanadelumab
|
0.04470 per day
Geometric Coefficient of Variation 9
|
0.04385 per day
Geometric Coefficient of Variation 11
|
PRIMARY outcome
Timeframe: Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dosePopulation: PK set consisted of all participants who received at least 1 dose of lanadelumab and had at least 1 evaluable post-dose PK concentration value.
t1/2 of Lanadelumab was presented.
Outcome measures
| Measure |
Japanese
n=16 Participants
Healthy participants of Japanese descent received a single dose of 300 mg lanadelumab SC injection in the abdomen.
|
Non-Hispanic Caucasians
n=16 Participants
Healthy Non-Hispanic Caucasian participants received a single dose of 300 mg lanadelumab SC injection in the abdomen.
|
|---|---|---|
|
Terminal Half-life (t12) of Lanadelumab
|
15.54 day
Interval 12.8 to 17.9
|
15.59 day
Interval 12.4 to 19.1
|
PRIMARY outcome
Timeframe: Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dosePopulation: PK set consisted of all participants who received at least 1 dose of lanadelumab and had at least 1 evaluable post-dose PK concentration value.
CL/F of Lanadelumab was presented.Geometric mean and geometric coefficient of variation percent (CV%) was presented.
Outcome measures
| Measure |
Japanese
n=16 Participants
Healthy participants of Japanese descent received a single dose of 300 mg lanadelumab SC injection in the abdomen.
|
Non-Hispanic Caucasians
n=16 Participants
Healthy Non-Hispanic Caucasian participants received a single dose of 300 mg lanadelumab SC injection in the abdomen.
|
|---|---|---|
|
Apparent Clearance (CL/F) of Lanadelumab
|
0.5826 liter per day
Geometric Coefficient of Variation 30
|
0.5428 liter per day
Geometric Coefficient of Variation 20
|
PRIMARY outcome
Timeframe: Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dosePopulation: PK set consisted of all participants who received at least 1 dose of lanadelumab and had at least 1 evaluable post-dose PK concentration value.
Vz/F of Lanadelumab was presented.Geometric mean and geometric coefficient of variation percent (CV%) was presented.
Outcome measures
| Measure |
Japanese
n=16 Participants
Healthy participants of Japanese descent received a single dose of 300 mg lanadelumab SC injection in the abdomen.
|
Non-Hispanic Caucasians
n=16 Participants
Healthy Non-Hispanic Caucasian participants received a single dose of 300 mg lanadelumab SC injection in the abdomen.
|
|---|---|---|
|
Apparent Volume of Distribution (Vz/F) of Lanadelumab
|
13.03 liter
Geometric Coefficient of Variation 29
|
12.38 liter
Geometric Coefficient of Variation 22
|
PRIMARY outcome
Timeframe: Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dosePopulation: PK set consisted of all participants who received at least 1 dose of lanadelumab and had at least 1 evaluable post-dose PK concentration value.
Body-weight adjusted AUC(0-last) of Lanadelumab was presented. Geometric mean and geometric coefficient of variation percent (CV%) was presented.
Outcome measures
| Measure |
Japanese
n=16 Participants
Healthy participants of Japanese descent received a single dose of 300 mg lanadelumab SC injection in the abdomen.
|
Non-Hispanic Caucasians
n=16 Participants
Healthy Non-Hispanic Caucasian participants received a single dose of 300 mg lanadelumab SC injection in the abdomen.
|
|---|---|---|
|
Body-weight Adjusted Area Under the Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) in Plasma of Lanadelumab
|
510.6 day*ug/mL/kg
Geometric Coefficient of Variation 30
|
547.6 day*ug/mL/kg
Geometric Coefficient of Variation 20
|
PRIMARY outcome
Timeframe: Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dosePopulation: PK set consisted of all participants who received at least 1 dose of lanadelumab and had at least 1 evaluable post-dose PK concentration value.
Body-weight adjusted AUC(0-infinity) of Lanadelumab was presented. Geometric mean and geometric coefficient of variation percent (CV%) was presented.
Outcome measures
| Measure |
Japanese
n=16 Participants
Healthy participants of Japanese descent received a single dose of 300 mg lanadelumab SC injection in the abdomen.
|
Non-Hispanic Caucasians
n=16 Participants
Healthy Non-Hispanic Caucasian participants received a single dose of 300 mg lanadelumab SC injection in the abdomen.
|
|---|---|---|
|
Body-weight Adjusted Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) in Plasma of Lanadelumab
|
8.012 day*ug/mL/kg
Geometric Coefficient of Variation 44
|
7.950 day*ug/mL/kg
Geometric Coefficient of Variation 27
|
PRIMARY outcome
Timeframe: Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dosePopulation: PK set consisted of all participants who received at least 1 dose of lanadelumab and had at least 1 evaluable post-dose PK concentration value.
Body-weight adjusted Cmax of Lanadelumab was presented.Geometric mean and geometric coefficient of variation percent (CV%) was presented.
Outcome measures
| Measure |
Japanese
n=16 Participants
Healthy participants of Japanese descent received a single dose of 300 mg lanadelumab SC injection in the abdomen.
|
Non-Hispanic Caucasians
n=16 Participants
Healthy Non-Hispanic Caucasian participants received a single dose of 300 mg lanadelumab SC injection in the abdomen.
|
|---|---|---|
|
Body-weight Adjusted Maximum Observed Plasma Concentration (Cmax) of Lanadelumab
|
0.3236 microgram per milliliter per kilogram
Interval 0.125 to 0.722
|
0.3042 microgram per milliliter per kilogram
Interval 0.196 to 0.709
|
PRIMARY outcome
Timeframe: Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dosePopulation: PK set consisted of all participants who received at least 1 dose of lanadelumab and had at least 1 evaluable post-dose PK concentration value.
Body-weight adjusted CL/F of Lanadelumab was presented.Geometric mean and geometric coefficient of variation percent (CV%) was presented.
Outcome measures
| Measure |
Japanese
n=16 Participants
Healthy participants of Japanese descent received a single dose of 300 mg lanadelumab SC injection in the abdomen.
|
Non-Hispanic Caucasians
n=16 Participants
Healthy Non-Hispanic Caucasian participants received a single dose of 300 mg lanadelumab SC injection in the abdomen.
|
|---|---|---|
|
Body-weight Adjusted Apparent Clearance (CL/F) of Lanadelumab
|
0.009064 liter per day per kilogram (L/day/kg)
Geometric Coefficient of Variation 23
|
0.007809 liter per day per kilogram (L/day/kg)
Geometric Coefficient of Variation 20
|
PRIMARY outcome
Timeframe: Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dosePopulation: PK set consisted of all participants who received at least 1 dose of lanadelumab and had at least 1 evaluable post-dose PK concentration value.
Body-weight adjusted Vz/F of Lanadelumab was presented.Geometric mean and geometric coefficient of variation percent (CV%) was presented.
Outcome measures
| Measure |
Japanese
n=16 Participants
Healthy participants of Japanese descent received a single dose of 300 mg lanadelumab SC injection in the abdomen.
|
Non-Hispanic Caucasians
n=16 Participants
Healthy Non-Hispanic Caucasian participants received a single dose of 300 mg lanadelumab SC injection in the abdomen.
|
|---|---|---|
|
Body-weight Adjusted Apparent Volume of Distribution (Vz/F) of Lanadelumab
|
0.2028 liter per kilogram (L/kg)
Geometric Coefficient of Variation 23
|
0.1781 liter per kilogram (L/kg)
Geometric Coefficient of Variation 20
|
SECONDARY outcome
Timeframe: From start of study drug administration up to follow-up (up to 115 days)Population: Safety analysis set included all participants who received at least 1 dose of Lanadelumab.
An adverse event (AE) is any untoward medical occurrence in a clinical investigation participants administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs are defined as AEs with onset at the time of or following the first exposure to study drug, or medical conditions present prior to the start of study drug but increasing in severity or relationship at the time of or following the start of treatment, up to the last follow-up visit. Severity of an AE is determined by following definitions: Mild: An event that does not generally interfere with usual activities of daily living; Moderate: An event that interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the research participants; Severe: An AE that interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention.
Outcome measures
| Measure |
Japanese
n=16 Participants
Healthy participants of Japanese descent received a single dose of 300 mg lanadelumab SC injection in the abdomen.
|
Non-Hispanic Caucasians
n=16 Participants
Healthy Non-Hispanic Caucasian participants received a single dose of 300 mg lanadelumab SC injection in the abdomen.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Based on Severity, Seriousness and Causality
Participants with Mild TEAE
|
6 Participants
|
4 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Based on Severity, Seriousness and Causality
Participants with Moderate TEAE
|
1 Participants
|
5 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Based on Severity, Seriousness and Causality
Participants with Severe TEAE
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Based on Severity, Seriousness and Causality
Participants with Serious TEAE
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Based on Severity, Seriousness and Causality
Participants with Non-Serious TEAE
|
7 Participants
|
9 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Based on Severity, Seriousness and Causality
Participants with Causality (Death)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From start of study drug administration up to follow-up (up to 115 days)Population: Safety analysis set included all participants who received at least 1 dose of Lanadelumab.
Clinical laboratory assessments include hematology, clinical chemistry, coagulation and urinalysis. The investigator will assess out-of-range clinical laboratory values for clinical significance, to indicate whether or not the values are clinically significant. Any changes from baseline in clinical laboratory results which are deemed clinically significant by the investigator are to be recorded as an AE.
Outcome measures
| Measure |
Japanese
n=16 Participants
Healthy participants of Japanese descent received a single dose of 300 mg lanadelumab SC injection in the abdomen.
|
Non-Hispanic Caucasians
n=16 Participants
Healthy Non-Hispanic Caucasian participants received a single dose of 300 mg lanadelumab SC injection in the abdomen.
|
|---|---|---|
|
Number of Participants With Clinically Significant Change in Clinical Laboratory Results Reported as an Adverse Event
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From start of study drug administration up to follow-up (up to 115 days)Population: Safety analysis set included all participants who received at least 1 dose of Lanadelumab.
Vital sign assessments include blood pressure, pulse rate and body temperature. Any changes from baseline in vital signs which are deemed clinically significant by the investigator are to be recorded as an AE.
Outcome measures
| Measure |
Japanese
n=16 Participants
Healthy participants of Japanese descent received a single dose of 300 mg lanadelumab SC injection in the abdomen.
|
Non-Hispanic Caucasians
n=16 Participants
Healthy Non-Hispanic Caucasian participants received a single dose of 300 mg lanadelumab SC injection in the abdomen.
|
|---|---|---|
|
Number of Participants With Clinically Significant Change in Vital Signs Reported as an Adverse Event
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From start of study drug administration up to follow-up (up to 115 days)Population: Safety analysis set includes all participants who received at least 1 dose of Lanadelumab.
Twelve-lead ECG will be performed after 5 minutes of rest in the supine position. Any change in ECG assessments which are deemed clinically significant by the investigator are to be reported as AE.
Outcome measures
| Measure |
Japanese
n=16 Participants
Healthy participants of Japanese descent received a single dose of 300 mg lanadelumab SC injection in the abdomen.
|
Non-Hispanic Caucasians
n=16 Participants
Healthy Non-Hispanic Caucasian participants received a single dose of 300 mg lanadelumab SC injection in the abdomen.
|
|---|---|---|
|
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Reported as an Adverse Event
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1, 14, 28, 56, and 112 (End of Study/Early Termination [EOS/ET])Population: Safety analysis set included all participants who received at least 1 dose of lanadelumab.
Plasma samples were analyzed for presence of antidrug antibodies to lanadelumab. Participants who show positive results for lanadelumab antibodies were reported.
Outcome measures
| Measure |
Japanese
n=16 Participants
Healthy participants of Japanese descent received a single dose of 300 mg lanadelumab SC injection in the abdomen.
|
Non-Hispanic Caucasians
n=16 Participants
Healthy Non-Hispanic Caucasian participants received a single dose of 300 mg lanadelumab SC injection in the abdomen.
|
|---|---|---|
|
Number of Participants Who Developed Antidrug Antibodies to Lanadelumab at Specified Time Points
Participants with positive ADA: Day 1
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Developed Antidrug Antibodies to Lanadelumab at Specified Time Points
Participants with positive ADA: Day 14
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Developed Antidrug Antibodies to Lanadelumab at Specified Time Points
Participants with positive ADA: Day 28
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Developed Antidrug Antibodies to Lanadelumab at Specified Time Points
Participants with positive ADA: Day 56
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Developed Antidrug Antibodies to Lanadelumab at Specified Time Points
Participants with positive ADA: Day 112 (EOS/ET)
|
0 Participants
|
1 Participants
|
Adverse Events
Japanese
Non-Hispanic Caucasians
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Japanese
n=16 participants at risk
Healthy participants of Japanese descent received a single dose of 300 mg lanadelumab SC injection in the abdomen.
|
Non-Hispanic Caucasians
n=16 participants at risk
Healthy Non-Hispanic Caucasian participants received a single dose of 300 mg lanadelumab SC injection in the abdomen.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
1/16 • Number of events 1 • From start of study drug administration up to follow-up (up to 115 days)
|
0.00%
0/16 • From start of study drug administration up to follow-up (up to 115 days)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/16 • From start of study drug administration up to follow-up (up to 115 days)
|
12.5%
2/16 • Number of events 2 • From start of study drug administration up to follow-up (up to 115 days)
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
1/16 • Number of events 1 • From start of study drug administration up to follow-up (up to 115 days)
|
0.00%
0/16 • From start of study drug administration up to follow-up (up to 115 days)
|
|
Gastrointestinal disorders
Constipation
|
6.2%
1/16 • Number of events 1 • From start of study drug administration up to follow-up (up to 115 days)
|
0.00%
0/16 • From start of study drug administration up to follow-up (up to 115 days)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16 • From start of study drug administration up to follow-up (up to 115 days)
|
12.5%
2/16 • Number of events 2 • From start of study drug administration up to follow-up (up to 115 days)
|
|
General disorders
Injection site erythema
|
6.2%
1/16 • Number of events 1 • From start of study drug administration up to follow-up (up to 115 days)
|
0.00%
0/16 • From start of study drug administration up to follow-up (up to 115 days)
|
|
General disorders
Injection site pain
|
0.00%
0/16 • From start of study drug administration up to follow-up (up to 115 days)
|
6.2%
1/16 • Number of events 1 • From start of study drug administration up to follow-up (up to 115 days)
|
|
General disorders
Vessel puncture site pain
|
6.2%
1/16 • Number of events 1 • From start of study drug administration up to follow-up (up to 115 days)
|
0.00%
0/16 • From start of study drug administration up to follow-up (up to 115 days)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/16 • From start of study drug administration up to follow-up (up to 115 days)
|
6.2%
1/16 • Number of events 1 • From start of study drug administration up to follow-up (up to 115 days)
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/16 • From start of study drug administration up to follow-up (up to 115 days)
|
12.5%
2/16 • Number of events 2 • From start of study drug administration up to follow-up (up to 115 days)
|
|
Infections and infestations
Rhinitis
|
0.00%
0/16 • From start of study drug administration up to follow-up (up to 115 days)
|
6.2%
1/16 • Number of events 1 • From start of study drug administration up to follow-up (up to 115 days)
|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
1/16 • Number of events 1 • From start of study drug administration up to follow-up (up to 115 days)
|
18.8%
3/16 • Number of events 3 • From start of study drug administration up to follow-up (up to 115 days)
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/16 • From start of study drug administration up to follow-up (up to 115 days)
|
6.2%
1/16 • Number of events 1 • From start of study drug administration up to follow-up (up to 115 days)
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/16 • From start of study drug administration up to follow-up (up to 115 days)
|
6.2%
1/16 • Number of events 1 • From start of study drug administration up to follow-up (up to 115 days)
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
6.2%
1/16 • Number of events 1 • From start of study drug administration up to follow-up (up to 115 days)
|
0.00%
0/16 • From start of study drug administration up to follow-up (up to 115 days)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/16 • From start of study drug administration up to follow-up (up to 115 days)
|
6.2%
1/16 • Number of events 1 • From start of study drug administration up to follow-up (up to 115 days)
|
|
Nervous system disorders
Headache
|
6.2%
1/16 • Number of events 1 • From start of study drug administration up to follow-up (up to 115 days)
|
12.5%
2/16 • Number of events 3 • From start of study drug administration up to follow-up (up to 115 days)
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/16 • From start of study drug administration up to follow-up (up to 115 days)
|
6.2%
1/16 • Number of events 1 • From start of study drug administration up to follow-up (up to 115 days)
|
|
Nervous system disorders
Syncope
|
0.00%
0/16 • From start of study drug administration up to follow-up (up to 115 days)
|
6.2%
1/16 • Number of events 1 • From start of study drug administration up to follow-up (up to 115 days)
|
|
Nervous system disorders
Tension headache
|
0.00%
0/16 • From start of study drug administration up to follow-up (up to 115 days)
|
6.2%
1/16 • Number of events 1 • From start of study drug administration up to follow-up (up to 115 days)
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/16 • From start of study drug administration up to follow-up (up to 115 days)
|
12.5%
2/16 • Number of events 2 • From start of study drug administration up to follow-up (up to 115 days)
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/16 • From start of study drug administration up to follow-up (up to 115 days)
|
6.2%
1/16 • Number of events 1 • From start of study drug administration up to follow-up (up to 115 days)
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
6.2%
1/16 • Number of events 1 • From start of study drug administration up to follow-up (up to 115 days)
|
0.00%
0/16 • From start of study drug administration up to follow-up (up to 115 days)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/16 • From start of study drug administration up to follow-up (up to 115 days)
|
6.2%
1/16 • Number of events 1 • From start of study drug administration up to follow-up (up to 115 days)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
- Publication restrictions are in place
Restriction type: OTHER