Trial Outcomes & Findings for A 3-Way Crossover Study to Evaluate the Pharmacokinetics in Participants After Dosing With Pegilodecakin (LY3500518) (NCT NCT03381547)
NCT ID: NCT03381547
Last Updated: 2026-07-07
Results Overview
Maximal serum concentration (Cmax) of pegilodecakin is reported.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
Period 1: Days 1-4 and Day 8 [Predose, 2, 4, 8, 12, 16, 24, 36, 48, 72, and 168 hours post-dose (Day 8 predose)]; Period 2: Days 8-11 and Day 15 [same as Days 1-4 and Day 8 (Day 15 predose)]; Period 3: Days 15-18 and Day 22 [same as Days 1-4 and Day 8]
Results posted on
2026-07-07
Participant Flow
3-way crossover study with 7 days washout period between doses.Two dose concentrations and two dose levels per weight bracket (participants who weighed at less than or equal to (≤) 80 kilogram (kg) (Body weight ≤ 80 kg) in the lower bracket and participants who weighed greater than (\>) 80 kg in the higher bracket (Body weight \>80 kg) were evaluated
Participant milestones
| Measure |
Sequence ABC
Period 1: Participants received AM0010 (pegilodecakin) subcutaneous (SQ) doses of 0.8 mg at 4 milligram/milliliter (mg/mL) administered as 0.2 mL injections for body weight ≤80 kg and SQ doses of 1.6 mg at 4 mg/mL administered as 0.4 mL injections for body weight \>80 kg.
Period 2: Participants received AM0010 (pegilodecakin) SQ doses of 0.4 mg at 4 mg/mL administered as 0.1 mL injections for body weight ≤80 kg and SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections for body weight \>80 kg.
Period 3: Participants received AM0010 (pegilodecakin) SQ doses of 0.4 mg at 2 mg/mL administered as 0.2 mL injections for body weight ≤80 kg and SQ doses of 0.8 mg at 2 mg/mL administered as 0.4 mL injections for body weight \>80 kg.
|
Sequence BAC
Period 1: Participants received AM0010 (pegilodecakin) SQ doses of 0.4 mg at 4 mg/mL administered as 0.1 mL injections for body weight ≤80 kg and SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections for body weight \>80 kg.
Period 2: Participants received AM0010 (pegilodecakin) SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections for body weight ≤80 kg and SQ doses of 1.6 mg at 4 mg/mL administered as 0.4 mL injections for body weight \>80 kg.
Period 3: Participants received AM0010 (pegilodecakin) SQ doses of 0.4 mg at 2 mg/mL administered as 0.2 mL injections for body weight ≤80 kg and SQ doses of 0.8 mg at 2 mg/mL administered as 0.4 mL injections for body weight \>80 kg.
|
Sequence CBA
Period 1: Participants received AM0010 (pegilodecakin) SQ doses of 0.4 mg at 2 mg/mL administered as 0.2 mL injections for body weight ≤80 kg and SQ doses of 0.8 mg at 2 mg/mL administered as 0.4 mL injections for body weight \>80 kg.
Period 2: Participants received AM0010 (pegilodecakin) SQ doses of 0.4 mg at 4 mg/mL administered as 0.1 mL injections for body weight ≤80 kg and SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections for body weight \>80 kg.
Period 3: Participants received AM0010 (pegilodecakin) SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections for body weight ≤80 kg and SQ doses of 1.6 mg at 4 mg/mL administered as 0.4 mL injections for body weight \>80 kg.
|
|---|---|---|---|
|
Period 1
STARTED
|
4
|
4
|
4
|
|
Period 1
Received at Least 1 Dose of Study Drug
|
4
|
4
|
4
|
|
Period 1
COMPLETED
|
4
|
4
|
4
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
|
Period 2
STARTED
|
4
|
4
|
4
|
|
Period 2
COMPLETED
|
4
|
4
|
4
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
|
Period 3
STARTED
|
4
|
4
|
4
|
|
Period 3
COMPLETED
|
4
|
4
|
4
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A 3-Way Crossover Study to Evaluate the Pharmacokinetics in Participants After Dosing With Pegilodecakin (LY3500518)
Baseline characteristics by cohort
| Measure |
Sequence ABC
n=4 Participants
Period 1: Participants received AM0010 ((pegilodecakin) subcutaneous (SQ) doses of 0.8 mg at 4 milligram/milliliter (mg/mL) administered as 0.2 mL injections for body weight ≤80 kg and SQ doses of 1.6 mg at 4 mg/mL administered as 0.4 mL injections for body weight \>80 kg.
Period 2: Participants received AM0010 (pegilodecakin) SQ doses of 0.4 mg at 4 mg/mL administered as 0.1 mL injections for body weight ≤80 kg and SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections for body weight \>80 kg.
Period 3: Participants received AM0010 (pegilodecakin) SQ doses of 0.4 mg at 2 mg/mL administered as 0.2 mL injections for body weight ≤80 kg and SQ doses of 0.8 mg at 2 mg/mL administered as 0.4 mL injections for body weight \>80 kg.
|
Sequence BAC
n=4 Participants
Period 1: Participants received AM0010 (pegilodecakin) SQ doses of 0.4 mg at 4 mg/mL administered as 0.1 mL injections for body weight ≤80 kg and SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections for body weight \>80 kg.
Period 2: Participants received AM0010 ((pegilodecakin) SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections for body weight ≤80 kg and SQ doses of 1.6 mg at 4 mg/mL administered as 0.4 mL injections for body weight \>80 kg.
Period 3: Participants received AM0010 (pegilodecakin) SQ doses of 0.4 mg at 2 mg/mL administered as 0.2 mL injections for body weight ≤80 kg and SQ doses of 0.8 mg at 2 mg/mL administered as 0.4 mL injections for body weight \>80 kg.
|
Sequence CBA
n=4 Participants
Period 1: Participants received AM0010 (pegilodecakin) SQ doses of 0.4 mg at 2 mg/mL administered as 0.2 mL injections for body weight ≤80 kg and SQ doses of 0.8 mg at 2 mg/mL administered as 0.4 mL injections for body weight \>80 kg.
Period 2: Participants received AM0010 (pegilodecakin) SQ doses of 0.4 mg at 4 mg/mL administered as 0.1 mL injections for body weight ≤80 kg and SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections for body weight \>80 kg.
Period 3: Participants received AM0010 (pegilodecakin) SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections for body weight ≤80 kg and SQ doses of 1.6 mg at 4 mg/mL administered as 0.4 mL injections for body weight \>80 kg.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41.0 years
STANDARD_DEVIATION 9.06 • n=20 Participants
|
33.8 years
STANDARD_DEVIATION 7.63 • n=20 Participants
|
28.8 years
STANDARD_DEVIATION 9.57 • n=40 Participants
|
34.5 years
STANDARD_DEVIATION 9.53 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Period 1: Days 1-4 and Day 8 [Predose, 2, 4, 8, 12, 16, 24, 36, 48, 72, and 168 hours post-dose (Day 8 predose)]; Period 2: Days 8-11 and Day 15 [same as Days 1-4 and Day 8 (Day 15 predose)]; Period 3: Days 15-18 and Day 22 [same as Days 1-4 and Day 8]Population: All randomized participants who received at least one dose of study drug and have evaluable PK data.
Maximal serum concentration (Cmax) of pegilodecakin is reported.
Outcome measures
| Measure |
Pegilodecakin: Treatment A
n=12 Participants
Participants received AM0010 (pegilodecakin) SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections for body weight ≤80 kg and SQ doses of 1.6 mg at 4 mg/mL administered as 0.4 mL injections for body weight \>80 kg.
|
Pegilodecakin: Treatment B
n=11 Participants
Participants received AM0010 (pegilodecakin) SQ doses of 0.4 mg at 4 mg/mL administered as 0.1 mL injections for body weight ≤80 kg and SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections for body weight \>80 kg.
|
Pegilodecakin: Treatment C
n=11 Participants
Participants received AM0010 (pegilodecakin) SQ doses of 0.4 mg at 2 mg/mL administered as 0.2 mL injections for body weight ≤80 kg and SQ doses of 0.8 mg at 2 mg/mL administered as 0.4 mL injections for body weight \>80 kg.
|
|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of Pegilodecakin
Body Weight ≤80 kg
|
8590 picogram per milliliter (pg/mL)
Geometric Coefficient of Variation 51
|
3820 picogram per milliliter (pg/mL)
Geometric Coefficient of Variation 54
|
4130 picogram per milliliter (pg/mL)
Geometric Coefficient of Variation 81
|
|
Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of Pegilodecakin
Body Weight >80 kg
|
18500 picogram per milliliter (pg/mL)
Geometric Coefficient of Variation 97
|
5970 picogram per milliliter (pg/mL)
Geometric Coefficient of Variation 70
|
11200 picogram per milliliter (pg/mL)
Geometric Coefficient of Variation 25
|
PRIMARY outcome
Timeframe: Period 1: Days 1-4 and Day 8 [Predose, 2, 4, 8, 12, 16, 24, 36, 48, 72, and 168 hours post-dose (Day 8 predose)]; Period 2: Days 8-11 and Day 15 [same as Days 1-4 and Day 8 (Day 15 predose)]; Period 3: Days 15-18 and Day 22 [same as Days 1-4 and Day 8]Population: All randomized participants who received at least one dose of study drug and have evaluable PK data.
Time of maximum serum concentration (Tmax) of Pegilodecakin is reported.
Outcome measures
| Measure |
Pegilodecakin: Treatment A
n=12 Participants
Participants received AM0010 (pegilodecakin) SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections for body weight ≤80 kg and SQ doses of 1.6 mg at 4 mg/mL administered as 0.4 mL injections for body weight \>80 kg.
|
Pegilodecakin: Treatment B
n=11 Participants
Participants received AM0010 (pegilodecakin) SQ doses of 0.4 mg at 4 mg/mL administered as 0.1 mL injections for body weight ≤80 kg and SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections for body weight \>80 kg.
|
Pegilodecakin: Treatment C
n=11 Participants
Participants received AM0010 (pegilodecakin) SQ doses of 0.4 mg at 2 mg/mL administered as 0.2 mL injections for body weight ≤80 kg and SQ doses of 0.8 mg at 2 mg/mL administered as 0.4 mL injections for body weight \>80 kg.
|
|---|---|---|---|
|
PK: Time of Maximum Concentration (Tmax) of Pegilodecakin
Body Weight ≤80 kg
|
16.00 hours (h)
Interval 8.0 to 24.0
|
8.00 hours (h)
Interval 4.0 to 12.0
|
12.00 hours (h)
Interval 8.0 to 16.0
|
|
PK: Time of Maximum Concentration (Tmax) of Pegilodecakin
Body Weight >80 kg
|
12.00 hours (h)
Interval 12.0 to 12.02
|
12.00 hours (h)
Interval 8.0 to 24.0
|
12.00 hours (h)
Interval 12.0 to 12.0
|
PRIMARY outcome
Timeframe: Period 1: Days 1-4 and Day 8 [Predose, 2, 4, 8, 12, 16, 24, 36, 48, 72, and 168 hours post-dose (Day 8 predose)]; Period 2: Days 8-11 and Day 15 [same as Days 1-4 and Day 8 (Day 15 predose)]; Period 3: Days 15-18 and Day 22 [same as Days 1-4 and Day 8]Population: All randomized participants who received at least one dose of study drug and have evaluable PK data.
AUC from time 0 to the time of the last quantifiable concentration \[AUC(0-tlast)\], AUC from time 0 to 72 hours \[AUC(0-72)\] and AUC from time 0 to infinity \[AUC(0-inf)\] of pegilodecakin is reported.
Outcome measures
| Measure |
Pegilodecakin: Treatment A
n=12 Participants
Participants received AM0010 (pegilodecakin) SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections for body weight ≤80 kg and SQ doses of 1.6 mg at 4 mg/mL administered as 0.4 mL injections for body weight \>80 kg.
|
Pegilodecakin: Treatment B
n=11 Participants
Participants received AM0010 (pegilodecakin) SQ doses of 0.4 mg at 4 mg/mL administered as 0.1 mL injections for body weight ≤80 kg and SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections for body weight \>80 kg.
|
Pegilodecakin: Treatment C
n=11 Participants
Participants received AM0010 (pegilodecakin) SQ doses of 0.4 mg at 2 mg/mL administered as 0.2 mL injections for body weight ≤80 kg and SQ doses of 0.8 mg at 2 mg/mL administered as 0.4 mL injections for body weight \>80 kg.
|
|---|---|---|---|
|
PK: Area Under the Concentration-Versus-Time Curve (AUC) of Pegilodecakin
Body Weight >80 kg: AUC(0-tlast)
|
593000 hour*picogram per milliliter (h*pg/mL)
Geometric Coefficient of Variation 73
|
187000 hour*picogram per milliliter (h*pg/mL)
Geometric Coefficient of Variation 51
|
342000 hour*picogram per milliliter (h*pg/mL)
Geometric Coefficient of Variation 24
|
|
PK: Area Under the Concentration-Versus-Time Curve (AUC) of Pegilodecakin
Body Weight ≤80 kg: AUC(0-72)
|
306000 hour*picogram per milliliter (h*pg/mL)
Geometric Coefficient of Variation 51
|
117000 hour*picogram per milliliter (h*pg/mL)
Geometric Coefficient of Variation 63
|
139000 hour*picogram per milliliter (h*pg/mL)
Geometric Coefficient of Variation 83
|
|
PK: Area Under the Concentration-Versus-Time Curve (AUC) of Pegilodecakin
Body Weight >80 kg: AUC(0-72)
|
514000 hour*picogram per milliliter (h*pg/mL)
Geometric Coefficient of Variation 81
|
176000 hour*picogram per milliliter (h*pg/mL)
Geometric Coefficient of Variation 43
|
298000 hour*picogram per milliliter (h*pg/mL)
Geometric Coefficient of Variation 28
|
|
PK: Area Under the Concentration-Versus-Time Curve (AUC) of Pegilodecakin
Body Weight ≤80 kg: AUC(0-inf)
|
362000 hour*picogram per milliliter (h*pg/mL)
Geometric Coefficient of Variation 51
|
134000 hour*picogram per milliliter (h*pg/mL)
Geometric Coefficient of Variation 65
|
162000 hour*picogram per milliliter (h*pg/mL)
Geometric Coefficient of Variation 86
|
|
PK: Area Under the Concentration-Versus-Time Curve (AUC) of Pegilodecakin
Body Weight >80 kg: AUC(0-inf)
|
606000 hour*picogram per milliliter (h*pg/mL)
Geometric Coefficient of Variation 70
|
259000 hour*picogram per milliliter (h*pg/mL)
Geometric Coefficient of Variation 13
|
349000 hour*picogram per milliliter (h*pg/mL)
Geometric Coefficient of Variation 23
|
|
PK: Area Under the Concentration-Versus-Time Curve (AUC) of Pegilodecakin
Body Weight ≤80 kg: AUC(0-tlast)
|
334000 hour*picogram per milliliter (h*pg/mL)
Geometric Coefficient of Variation 54
|
119000 hour*picogram per milliliter (h*pg/mL)
Geometric Coefficient of Variation 67
|
149000 hour*picogram per milliliter (h*pg/mL)
Geometric Coefficient of Variation 90
|
PRIMARY outcome
Timeframe: Period 1: Days 1-4 and Day 8 [Predose, 2, 4, 8, 12, 16, 24, 36, 48, 72, and 168 hours post-dose (Day 8 predose)]; Period 2: Days 8-11 and Day 15 [same as Days 1-4 and Day 8 (Day 15 predose)]; Period 3: Days 15-18 and Day 22 [same as Days 1-4 and Day 8]Population: All randomized participants who received at least one dose of study drug and have evaluable PK data.
Apparent total body clearance ((CL/F) is the volume of serum from which the drug is completely removed in a given time period.
Outcome measures
| Measure |
Pegilodecakin: Treatment A
n=12 Participants
Participants received AM0010 (pegilodecakin) SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections for body weight ≤80 kg and SQ doses of 1.6 mg at 4 mg/mL administered as 0.4 mL injections for body weight \>80 kg.
|
Pegilodecakin: Treatment B
n=11 Participants
Participants received AM0010 (pegilodecakin) SQ doses of 0.4 mg at 4 mg/mL administered as 0.1 mL injections for body weight ≤80 kg and SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections for body weight \>80 kg.
|
Pegilodecakin: Treatment C
n=11 Participants
Participants received AM0010 (pegilodecakin) SQ doses of 0.4 mg at 2 mg/mL administered as 0.2 mL injections for body weight ≤80 kg and SQ doses of 0.8 mg at 2 mg/mL administered as 0.4 mL injections for body weight \>80 kg.
|
|---|---|---|---|
|
PK: Apparent Total Body Clearance of (CL/F) of Pegilodecakin
Body Weight ≤80 kg
|
2.21 Liter/hour (L/h)
Geometric Coefficient of Variation 51
|
2.98 Liter/hour (L/h)
Geometric Coefficient of Variation 65
|
2.47 Liter/hour (L/h)
Geometric Coefficient of Variation 86
|
|
PK: Apparent Total Body Clearance of (CL/F) of Pegilodecakin
Body Weight >80 kg
|
2.64 Liter/hour (L/h)
Geometric Coefficient of Variation 70
|
3.08 Liter/hour (L/h)
Geometric Coefficient of Variation 13
|
2.29 Liter/hour (L/h)
Geometric Coefficient of Variation 23
|
Adverse Events
Pegilodecakin: Treatment A
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Pegilodecakin: Treatment B
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Pegilodecakin: Treatment C
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 |
Pegilodecakin: Treatment A
n=12 participants at risk
Participants received AM0010 (pegilodecakin) SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections for body weight ≤80 kg and SQ doses of 1.6 mg at 4 mg/mL administered as 0.4 mL injections for body weight \>80 kg.
|
Pegilodecakin: Treatment B
n=12 participants at risk
Participants received AM0010 (pegilodecakin) SQ doses of 0.4 mg at 4 mg/mL administered as 0.1 mL injections for body weight ≤80 kg and SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections for body weight \>80 kg.
|
Pegilodecakin: Treatment C
n=12 participants at risk
Participants received AM0010 (pegilodecakin) SQ doses of 0.4 mg at 2 mg/mL administered as 0.2 mL injections for body weight ≤80 kg and SQ doses of 0.8 mg at 2 mg/mL administered as 0.4 mL injections for body weight \>80 kg.
|
|---|---|---|---|
|
General disorders
Flu-like symptoms
|
0.00%
0/12 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 1 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Injection site reaction left upper quadrant ecchymosis
|
0.00%
0/12 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 1 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Injection site reaction left upper quadrant erythema
|
8.3%
1/12 • Number of events 1 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
58.3%
7/12 • Number of events 7 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Injection site reaction left upper quadrant pruritus
|
8.3%
1/12 • Number of events 1 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
25.0%
3/12 • Number of events 3 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Injection site reaction right lower quadrant ecchymosis
|
8.3%
1/12 • Number of events 1 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Injection site reaction right lower quadrant erythema
|
33.3%
4/12 • Number of events 4 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
25.0%
3/12 • Number of events 3 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
33.3%
4/12 • Number of events 5 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Injection site reaction right lower quadrant pruritus
|
8.3%
1/12 • Number of events 1 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
16.7%
2/12 • Number of events 2 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
16.7%
2/12 • Number of events 2 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Injection site reaction right lower quadrant swelling
|
0.00%
0/12 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 1 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 1 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Injection site reaction right upper quadrant erythema
|
25.0%
3/12 • Number of events 3 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
58.3%
7/12 • Number of events 7 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/12 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 1 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Injection site reaction right upper quadrant injection site streaking
|
8.3%
1/12 • Number of events 1 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Injection site reaction right upper quadrant pruritus
|
0.00%
0/12 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
16.7%
2/12 • Number of events 2 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 2 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
1/12 • Number of events 1 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.3%
1/12 • Number of events 1 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 1 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/12 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 1 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 1 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
8.3%
1/12 • Number of events 1 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • Number of events 1 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Chills
|
8.3%
1/12 • Number of events 1 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 1 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Eye irritation
|
0.00%
0/12 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 1 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal bloating
|
0.00%
0/12 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 1 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Decreased frequency of bowel movements
|
0.00%
0/12 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 1 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • Number of events 1 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 1 • Up To 22 Days
All randomized participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI may not publish any articles or make any presentations related to the services provided by sponsor here under with respect to a project or referring to data, information or materials generated as part of the services without the prior written consent of sponsor.
- Publication restrictions are in place
Restriction type: OTHER