Trial Outcomes & Findings for A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Ascending, Subcutaneous, Single and Multiple Doses of SHP681 (Glucagon-like Peptide-2 [GLP-2] Analog-Fc Fusion) in Healthy Adult Participants (NCT NCT03859323)

Last Updated: 2021-02-25

Results Overview

Adverse event (AE) was any unfavorable and unintended sign, symptom, or disease temporally associated with study or use of investigational drug product (IP), whether or not the AE was considered related to IP. TEAEs: AEs occurring or worsening at or after first dose of IP or ongoing at time of enrollment. SAE :untoward medical occurrence that at any dose met one, more of the following criteria: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event. Severity: Mild: event that does not generally interfere with usual activities of daily living; Moderate: event that interferes with usual activities of daily living, causing discomfort, permanent risk of harm; Severe: AE that interrupts usual activities of daily living, significantly affects clinical status, or may require intensive therapeutic intervention.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

104 participants

Primary outcome timeframe

From start of study drug administration up to follow-up (Day 29 for SAD)

Results posted on

2021-02-25

Participant Flow

This study was conducted at single site in United States of America from 25 March 2019 (first participant first visit) and 06 January 2020 (last participant last visit).

This study consisted of 2 parts: Part A - single ascending dose (SAD) and Part B - multiple ascending dose (MAD). A total of 104 participants were randomized in 2 parts with 30 participants to SAD and 74 participants to MAD, out of which 95 participants completed the study.

Participant milestones

Participant milestones
Measure	Part 1: Single Ascending Dose (SAD): Placebo Participants received single subcutaneous (SC) injection of placebo matched to SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.2 mg/kg Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.5 mg/kg Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 1 mg/kg Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 2 mg/kg Participants received single SC injection of 2 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 4 mg/kg Participants received single SC injection of 4 mg/kg SHP681 in the abdomen on Day 1.	Part 2: Multiple Ascending Dose (MAD): Placebo Participants received SC injection of placebo matched to SHP681 once weekly for 5 weeks in the abdomen up to Day 29.	Part 2: Multiple Ascending Dose (MAD): 0.2 mg/kg Participants received SC injection of 0.2 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.	Part 2: Multiple Ascending Dose (MAD): 0.5 mg/kg Participants received SC injection of 0.5 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.	Part 2: Multiple Ascending Dose (MAD): 1 mg/kg Participants received SC injection of 1 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.	Part 2: Multiple Ascending Dose (MAD): 2 mg/kg Participants received SC injection of 2 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.	Part 2: Multiple Ascending Dose (MAD): 4 mg/kg Participants received SC injection of 4 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.	Part 2: Multiple Ascending Dose (MAD): 4 mg/kg (Q2W) Participants received SC injection of placebo matched to SHP681 twice weekly (Q2W) for 5 weeks in the abdomen up to Day 29.
Overall Study STARTED	5	5	5	5	5	5	12	10	10	10	10	12	10
Overall Study COMPLETED	5	5	4	5	5	4	11	10	10	8	9	10	9
Overall Study NOT COMPLETED	0	0	1	0	0	1	1	0	0	2	1	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1: Single Ascending Dose (SAD): 0.5 mg/kg Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 4 mg/kg Participants received single SC injection of 4 mg/kg SHP681 in the abdomen on Day 1.	Part 2: Multiple Ascending Dose (MAD): Placebo Participants received SC injection of placebo matched to SHP681 once weekly for 5 weeks in the abdomen up to Day 29.	Part 2: Multiple Ascending Dose (MAD): 1 mg/kg Participants received SC injection of 1 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.	Part 2: Multiple Ascending Dose (MAD): 2 mg/kg Participants received SC injection of 2 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.	Part 2: Multiple Ascending Dose (MAD): 4 mg/kg Participants received SC injection of 4 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.	Part 2: Multiple Ascending Dose (MAD): 4 mg/kg (Q2W) Participants received SC injection of placebo matched to SHP681 twice weekly (Q2W) for 5 weeks in the abdomen up to Day 29.
Overall Study Lost to Follow-up	0	0	1	0	0	0	0
Overall Study Withdrawal by Subject	1	1	0	1	1	2	1
Overall Study Pregnancy	0	0	0	1	0	0	0

Baseline Characteristics

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Ascending, Subcutaneous, Single and Multiple Doses of SHP681 (Glucagon-like Peptide-2 [GLP-2] Analog-Fc Fusion) in Healthy Adult Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1: Single Ascending Dose (SAD): Placebo n=5 Participants Participants received single subcutaneous (SC) injection of placebo matched to SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.2 mg/kg n=5 Participants Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.5 mg/kg n=5 Participants Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 1 mg/kg n=5 Participants Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 2 mg/kg n=5 Participants Participants received single SC injection of 2 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 4 mg/kg n=5 Participants Participants received single SC injection of 4 mg/kg SHP681 in the abdomen on Day 1.	Part 2: Multiple Ascending Dose (MAD): Placebo n=12 Participants Participants received SC injection of placebo matched to SHP681 once weekly for 5 weeks in the abdomen up to Day 29.	Part 2: Multiple Ascending Dose (MAD): 0.2 mg/kg n=10 Participants Participants received SC injection of 0.2 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.	Part 2: Multiple Ascending Dose (MAD): 0.5 mg/kg n=10 Participants Participants received SC injection of 0.5 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.	Part 2: Multiple Ascending Dose (MAD): 1 mg/kg n=10 Participants Participants received SC injection of 1 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.	Part 2: Multiple Ascending Dose (MAD): 2 mg/kg n=10 Participants Participants received SC injection of 2 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.	Part 2: Multiple Ascending Dose (MAD): 4 mg/kg n=12 Participants Participants received SC injection of 4 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.	Part 2: Multiple Ascending Dose (MAD): 4 mg/kg (Q2W) n=10 Participants Participants received SC injection of placebo matched to SHP681 twice weekly (Q2W) for 5 weeks in the abdomen up to Day 29.	Total n=104 Participants Total of all reporting groups
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=36 Participants	2 Participants n=36 Participants
Age, Continuous	33.6 Years STANDARD_DEVIATION 12.93 • n=5 Participants	28.8 Years STANDARD_DEVIATION 7.60 • n=7 Participants	38.0 Years STANDARD_DEVIATION 9.19 • n=5 Participants	41.4 Years STANDARD_DEVIATION 8.32 • n=4 Participants	33.0 Years STANDARD_DEVIATION 7.35 • n=21 Participants	29.8 Years STANDARD_DEVIATION 3.96 • n=8 Participants	31.2 Years STANDARD_DEVIATION 9.34 • n=8 Participants	32.1 Years STANDARD_DEVIATION 8.63 • n=24 Participants	32.5 Years STANDARD_DEVIATION 9.47 • n=42 Participants	28.4 Years STANDARD_DEVIATION 9.52 • n=42 Participants	32.7 Years STANDARD_DEVIATION 9.38 • n=42 Participants	29.8 Years STANDARD_DEVIATION 10.38 • n=42 Participants	32.0 Years STANDARD_DEVIATION 8.45 • n=36 Participants	32.0 Years STANDARD_DEVIATION 9.13 • n=36 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants	3 Participants n=8 Participants	1 Participants n=24 Participants	3 Participants n=42 Participants	6 Participants n=42 Participants	2 Participants n=42 Participants	5 Participants n=42 Participants	2 Participants n=36 Participants	33 Participants n=36 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	5 Participants n=21 Participants	3 Participants n=8 Participants	9 Participants n=8 Participants	9 Participants n=24 Participants	7 Participants n=42 Participants	4 Participants n=42 Participants	8 Participants n=42 Participants	7 Participants n=42 Participants	8 Participants n=36 Participants	71 Participants n=36 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants	3 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=36 Participants	10 Participants n=36 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	5 Participants n=21 Participants	4 Participants n=8 Participants	11 Participants n=8 Participants	9 Participants n=24 Participants	10 Participants n=42 Participants	8 Participants n=42 Participants	7 Participants n=42 Participants	11 Participants n=42 Participants	9 Participants n=36 Participants	94 Participants n=36 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	1 Participants n=36 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants	4 Participants n=8 Participants	1 Participants n=24 Participants	3 Participants n=42 Participants	4 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants	1 Participants n=36 Participants	24 Participants n=36 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants	3 Participants n=8 Participants	7 Participants n=8 Participants	7 Participants n=24 Participants	7 Participants n=42 Participants	6 Participants n=42 Participants	10 Participants n=42 Participants	8 Participants n=42 Participants	9 Participants n=36 Participants	75 Participants n=36 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=36 Participants	2 Participants n=36 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants

PRIMARY outcome

Timeframe: From start of study drug administration up to follow-up (Day 29 for SAD)

Population: SAS included participants who had received at least 1 dose of SHP681 or placebo.

Outcome measures

Outcome measures
Measure	Part 1: Single Ascending Dose (SAD): Placebo n=5 Participants Participants received single subcutaneous (SC) injection of placebo matched to SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.2 mg/kg n=5 Participants Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.5 mg/kg n=5 Participants Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 1 mg/kg n=5 Participants Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 2 mg/kg n=5 Participants Participants received single SC injection of 2 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 4 mg/kg n=5 Participants Participants received single SC injection of 4 mg/kg SHP681 in the abdomen on Day 1.	Part 2: Multiple Ascending Dose (MAD): 4 mg/kg (Q2W) Participants received SC injection of placebo matched to SHP681 twice weekly (Q2W) for 5 weeks in the abdomen up to Day 29.
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Based on Severity to SHP681 in Single Ascending Dose (SAD) Participants with TEAEs	3 Participants	3 Participants	2 Participants	4 Participants	3 Participants	2 Participants	—
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Based on Severity to SHP681 in Single Ascending Dose (SAD) Participants with Serious TEAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Based on Severity to SHP681 in Single Ascending Dose (SAD) Participants with Mild TEAEs	3 Participants	3 Participants	2 Participants	4 Participants	3 Participants	2 Participants	—
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Based on Severity to SHP681 in Single Ascending Dose (SAD) Participants with Moderate TEAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Based on Severity to SHP681 in Single Ascending Dose (SAD) Participants with Severe TEAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

PRIMARY outcome

Timeframe: From start of study drug administration up to follow-up (Day 57 for MAD)

Population: SAS included participants who had received at least 1 dose of SHP681 or placebo.

AE was any unfavorable and unintended sign, symptom, or disease temporally associated with study or use of investigational drug product (IP), whether or not the AE was considered related to IP. TEAEs: AEs occurring or worsening at or after first dose of IP or ongoing at time of enrollment. SAE :untoward medical occurrence that at any dose met one, more of the following criteria: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event. Severity: Mild: event that does not generally interfere with usual activities of daily living; Moderate: event that interferes with usual activities of daily living, causing discomfort, permanent risk of harm; Severe: AE that interrupts usual activities of daily living, significantly affects clinical status, or may require intensive therapeutic intervention.

Outcome measures

Outcome measures
Measure	Part 1: Single Ascending Dose (SAD): Placebo n=12 Participants Participants received single subcutaneous (SC) injection of placebo matched to SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.2 mg/kg n=10 Participants Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.5 mg/kg n=10 Participants Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 1 mg/kg n=10 Participants Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 2 mg/kg n=10 Participants Participants received single SC injection of 2 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 4 mg/kg n=12 Participants Participants received single SC injection of 4 mg/kg SHP681 in the abdomen on Day 1.	Part 2: Multiple Ascending Dose (MAD): 4 mg/kg (Q2W) n=10 Participants Participants received SC injection of placebo matched to SHP681 twice weekly (Q2W) for 5 weeks in the abdomen up to Day 29.
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Based on Severity to SHP681 in Multiple Ascending Dose (MAD) Participants with TEAEs	9 Participants	8 Participants	3 Participants	6 Participants	5 Participants	9 Participants	8 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Based on Severity to SHP681 in Multiple Ascending Dose (MAD) Participants with Serious TEAEs	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Based on Severity to SHP681 in Multiple Ascending Dose (MAD) Participants with Mild TEAEs	9 Participants	8 Participants	3 Participants	6 Participants	5 Participants	9 Participants	8 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Based on Severity to SHP681 in Multiple Ascending Dose (MAD) Participants with Moderate TEAEs	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Based on Severity to SHP681 in Multiple Ascending Dose (MAD) Participants with Severe TEAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 29

Population: SAS included participants who had received at least 1 dose of SHP681 or placebo. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure.

Antibody testing was conducted using an electro chemiluminescent signal method. Number of participants with ADA to SHP681 in SAD at Day 29 were reported.

Outcome measures

Outcome measures
Measure	Part 1: Single Ascending Dose (SAD): Placebo n=5 Participants Participants received single subcutaneous (SC) injection of placebo matched to SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.2 mg/kg n=5 Participants Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.5 mg/kg n=4 Participants Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 1 mg/kg n=5 Participants Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 2 mg/kg n=5 Participants Participants received single SC injection of 2 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 4 mg/kg n=4 Participants Participants received single SC injection of 4 mg/kg SHP681 in the abdomen on Day 1.	Part 2: Multiple Ascending Dose (MAD): 4 mg/kg (Q2W) Participants received SC injection of placebo matched to SHP681 twice weekly (Q2W) for 5 weeks in the abdomen up to Day 29.
Number of Participants With Anti-drug Antibody (ADA) to SHP681 in Single Ascending Dose (SAD) at Day 29	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

PRIMARY outcome

Timeframe: Day 36

Population: SAS included participants who had received at least 1 dose of SHP681 or placebo. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure.

Antibody testing was conducted using an electro chemiluminescent signal method. Number of participants with ADA to SHP681 in MAD at Day 36 were reported.

Outcome measures

Outcome measures
Measure	Part 1: Single Ascending Dose (SAD): Placebo n=12 Participants Participants received single subcutaneous (SC) injection of placebo matched to SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.2 mg/kg n=10 Participants Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.5 mg/kg n=10 Participants Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 1 mg/kg n=8 Participants Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 2 mg/kg n=9 Participants Participants received single SC injection of 2 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 4 mg/kg n=10 Participants Participants received single SC injection of 4 mg/kg SHP681 in the abdomen on Day 1.	Part 2: Multiple Ascending Dose (MAD): 4 mg/kg (Q2W) n=9 Participants Participants received SC injection of placebo matched to SHP681 twice weekly (Q2W) for 5 weeks in the abdomen up to Day 29.
Number of Participants With Anti-drug Antibody (ADA) to SHP681 in Multiple Ascending Dose (MAD) at Day 36	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 57

Population: SAS included participants who had received at least 1 dose of SHP681 or placebo. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure.

Antibody testing was conducted using an electro chemiluminescent signal method. Number of participants with ADA to SHP681 in MAD at Day 57 were reported.

Outcome measures

Outcome measures
Measure	Part 1: Single Ascending Dose (SAD): Placebo n=11 Participants Participants received single subcutaneous (SC) injection of placebo matched to SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.2 mg/kg n=10 Participants Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.5 mg/kg n=10 Participants Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 1 mg/kg n=8 Participants Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 2 mg/kg n=9 Participants Participants received single SC injection of 2 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 4 mg/kg n=10 Participants Participants received single SC injection of 4 mg/kg SHP681 in the abdomen on Day 1.	Part 2: Multiple Ascending Dose (MAD): 4 mg/kg (Q2W) n=9 Participants Participants received SC injection of placebo matched to SHP681 twice weekly (Q2W) for 5 weeks in the abdomen up to Day 29.
Number of Participants With Anti-drug Antibody (ADA) to SHP681 in Multiple Ascending Dose (MAD) at Day 57	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Pre-dose, 3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 hours post-dose

Population: Pharmacokinetic (PK) analysis set consisted of participants who received at least 1 dose of SHP681 and had at least 1 evaluable post-dose PK concentration value which was evaluable and interpretable.

Cmax of SHP681 during SAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.

Outcome measures

Outcome measures
Measure	Part 1: Single Ascending Dose (SAD): Placebo n=5 Participants Participants received single subcutaneous (SC) injection of placebo matched to SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.2 mg/kg n=5 Participants Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.5 mg/kg n=5 Participants Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 1 mg/kg n=5 Participants Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 2 mg/kg n=5 Participants Participants received single SC injection of 2 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 4 mg/kg Participants received single SC injection of 4 mg/kg SHP681 in the abdomen on Day 1.	Part 2: Multiple Ascending Dose (MAD): 4 mg/kg (Q2W) Participants received SC injection of placebo matched to SHP681 twice weekly (Q2W) for 5 weeks in the abdomen up to Day 29.
Maximum Observed Plasma Concentration (Cmax) of SHP681 During Single Ascending Dose (SAD)	0.8399 Micrograms per milliliter (mcg/mL) Geometric Coefficient of Variation 73.2	1.515 Micrograms per milliliter (mcg/mL) Geometric Coefficient of Variation 27.7	4.200 Micrograms per milliliter (mcg/mL) Geometric Coefficient of Variation 26.8	8.647 Micrograms per milliliter (mcg/mL) Geometric Coefficient of Variation 28.4	18.39 Micrograms per milliliter (mcg/mL) Geometric Coefficient of Variation 25.2	—	—

SECONDARY outcome

Timeframe: Pre-dose, 3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 hours post-dose

Population: PK analysis set consisted of participants who received at least 1 dose of SHP681 and had at least 1 evaluable post-dose PK concentration value which was evaluable and interpretable.

tlast of SHP681 during SAD was reported.

Outcome measures

Outcome measures
Measure	Part 1: Single Ascending Dose (SAD): Placebo n=5 Participants Participants received single subcutaneous (SC) injection of placebo matched to SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.2 mg/kg n=5 Participants Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.5 mg/kg n=5 Participants Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 1 mg/kg n=5 Participants Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 2 mg/kg n=5 Participants Participants received single SC injection of 2 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 4 mg/kg Participants received single SC injection of 4 mg/kg SHP681 in the abdomen on Day 1.	Part 2: Multiple Ascending Dose (MAD): 4 mg/kg (Q2W) Participants received SC injection of placebo matched to SHP681 twice weekly (Q2W) for 5 weeks in the abdomen up to Day 29.
Time of the Last Measurable Concentration (Tlast) of SHP681 During Single Ascending Dose (SAD)	335.0 Hour Interval 312.0 to 504.0	504.0 Hour Interval 504.0 to 672.0	673.0 Hour Interval 671.0 to 696.0	672.0 Hour Interval 648.0 to 673.0	672.0 Hour Interval 168.0 to 673.0	—	—

SECONDARY outcome

Timeframe: Pre-dose, 3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 hours post-dose

Population: PK analysis set consisted of participants who received at least 1 dose of SHP681 and had at least 1 evaluable post-dose PK concentration value which was evaluable and interpretable.

tmax of SHP681 during SAD was reported.

Outcome measures

Outcome measures
Measure	Part 1: Single Ascending Dose (SAD): Placebo n=5 Participants Participants received single subcutaneous (SC) injection of placebo matched to SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.2 mg/kg n=5 Participants Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.5 mg/kg n=5 Participants Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 1 mg/kg n=5 Participants Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 2 mg/kg n=5 Participants Participants received single SC injection of 2 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 4 mg/kg Participants received single SC injection of 4 mg/kg SHP681 in the abdomen on Day 1.	Part 2: Multiple Ascending Dose (MAD): 4 mg/kg (Q2W) Participants received SC injection of placebo matched to SHP681 twice weekly (Q2W) for 5 weeks in the abdomen up to Day 29.
Time of Maximum Observed Concentration Sampled During a Dosing Interval (Tmax) of SHP681 During Single Ascending Dose (SAD)	24.00 Hour Interval 24.0 to 96.0	72.00 Hour Interval 48.0 to 96.0	48.00 Hour Interval 48.0 to 72.0	72.00 Hour Interval 48.0 to 96.0	72.00 Hour Interval 48.0 to 96.0	—	—

SECONDARY outcome

Timeframe: Pre-dose, 3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 hours post-dose

Population: PK analysis set consisted of participants who received at least 1 dose of SHP681 and had at least 1 evaluable post-dose PK concentration value which was evaluable and interpretable.

AUC0-last of SHP681 during SAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.

Outcome measures

Outcome measures
Measure	Part 1: Single Ascending Dose (SAD): Placebo n=5 Participants Participants received single subcutaneous (SC) injection of placebo matched to SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.2 mg/kg n=5 Participants Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.5 mg/kg n=5 Participants Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 1 mg/kg n=5 Participants Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 2 mg/kg n=5 Participants Participants received single SC injection of 2 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 4 mg/kg Participants received single SC injection of 4 mg/kg SHP681 in the abdomen on Day 1.	Part 2: Multiple Ascending Dose (MAD): 4 mg/kg (Q2W) Participants received SC injection of placebo matched to SHP681 twice weekly (Q2W) for 5 weeks in the abdomen up to Day 29.
Area Under the Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-last) of SHP681 During Single Ascending Dose (SAD)	131.4 Hourmicrogram per milliliter (hmcg/mL) Geometric Coefficient of Variation 43.7	282.1 Hourmicrogram per milliliter (hmcg/mL) Geometric Coefficient of Variation 31.9	794.6 Hourmicrogram per milliliter (hmcg/mL) Geometric Coefficient of Variation 16.3	1722 Hourmicrogram per milliliter (hmcg/mL) Geometric Coefficient of Variation 25.6	3414 Hourmicrogram per milliliter (hmcg/mL) Geometric Coefficient of Variation 23.5	—	—

SECONDARY outcome

Timeframe: Pre-dose, 3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 hours post-dose

Population: PK analysis set consisted of participants who received at least 1 dose of SHP681 and had at least 1 evaluable post-dose PK concentration value which was evaluable and interpretable.

AUC0-inf of SHP681 during SAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.

Outcome measures

Outcome measures
Measure	Part 1: Single Ascending Dose (SAD): Placebo n=5 Participants Participants received single subcutaneous (SC) injection of placebo matched to SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.2 mg/kg n=5 Participants Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.5 mg/kg n=5 Participants Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 1 mg/kg n=5 Participants Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 2 mg/kg n=5 Participants Participants received single SC injection of 2 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 4 mg/kg Participants received single SC injection of 4 mg/kg SHP681 in the abdomen on Day 1.	Part 2: Multiple Ascending Dose (MAD): 4 mg/kg (Q2W) Participants received SC injection of placebo matched to SHP681 twice weekly (Q2W) for 5 weeks in the abdomen up to Day 29.
Area Under the Curve Extrapolated to Infinity (AUC0-inf) of SHP681 During Single Ascending Dose (SAD)	141.0 h*mcg/mL Geometric Coefficient of Variation 36.9	288.6 h*mcg/mL Geometric Coefficient of Variation 31.3	808.3 h*mcg/mL Geometric Coefficient of Variation 16.4	1739 h*mcg/mL Geometric Coefficient of Variation 25.8	3446 h*mcg/mL Geometric Coefficient of Variation 23.5	—	—

SECONDARY outcome

Timeframe: Pre-dose, 3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 hours post-dose

Population: PK analysis set consisted of participants who received at least 1 dose of SHP681 and had at least 1 evaluable post-dose PK concentration value which was evaluable and interpretable.

t1/2 of SHP681 during SAD was reported.

Outcome measures

Outcome measures
Measure	Part 1: Single Ascending Dose (SAD): Placebo n=5 Participants Participants received single subcutaneous (SC) injection of placebo matched to SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.2 mg/kg n=5 Participants Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.5 mg/kg n=5 Participants Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 1 mg/kg n=5 Participants Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 2 mg/kg n=5 Participants Participants received single SC injection of 2 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 4 mg/kg Participants received single SC injection of 4 mg/kg SHP681 in the abdomen on Day 1.	Part 2: Multiple Ascending Dose (MAD): 4 mg/kg (Q2W) Participants received SC injection of placebo matched to SHP681 twice weekly (Q2W) for 5 weeks in the abdomen up to Day 29.
Terminal Half-life (t1/2) of SHP681 During Single Ascending Dose (SAD)	94.50 Hour Interval 64.9 to 109.0	88.40 Hour Interval 76.0 to 104.0	97.10 Hour Interval 90.1 to 124.0	95.40 Hour Interval 87.8 to 116.0	97.80 Hour Interval 86.6 to 127.0	—	—

SECONDARY outcome

Timeframe: Pre-dose, 3, 6, 12, 24 hours post-dose

Population: PK analysis set consisted of participants who received at least 1 dose of SHP681 and had at least 1 evaluable post-dose PK concentration value which was evaluable and interpretable.

Cavg,0-24 of SHP681 during SAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.

Outcome measures

Outcome measures
Measure	Part 1: Single Ascending Dose (SAD): Placebo n=5 Participants Participants received single subcutaneous (SC) injection of placebo matched to SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.2 mg/kg n=5 Participants Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.5 mg/kg n=5 Participants Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 1 mg/kg n=5 Participants Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 2 mg/kg n=5 Participants Participants received single SC injection of 2 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 4 mg/kg Participants received single SC injection of 4 mg/kg SHP681 in the abdomen on Day 1.	Part 2: Multiple Ascending Dose (MAD): 4 mg/kg (Q2W) Participants received SC injection of placebo matched to SHP681 twice weekly (Q2W) for 5 weeks in the abdomen up to Day 29.
Average Concentration From Time Zero to 24 Hours Post Dose (Cavg,0-24) of SHP681 During Single Ascending Dose (SAD)	0.3733 Microgram per milliliter (mcg/mL) Geometric Coefficient of Variation 227.3	0.6020 Microgram per milliliter (mcg/mL) Geometric Coefficient of Variation 41.3	1.995 Microgram per milliliter (mcg/mL) Geometric Coefficient of Variation 36.0	3.193 Microgram per milliliter (mcg/mL) Geometric Coefficient of Variation 43.7	7.401 Microgram per milliliter (mcg/mL) Geometric Coefficient of Variation 52.3	—	—

SECONDARY outcome

Timeframe: Pre-dose, 3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 hours post-dose

Population: PK analysis set consisted of participants who received at least 1 dose of SHP681 and had at least 1 evaluable post-dose PK concentration value which was evaluable and interpretable.

Lambda z of SHP681 during SAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.

Outcome measures

Outcome measures
Measure	Part 1: Single Ascending Dose (SAD): Placebo n=5 Participants Participants received single subcutaneous (SC) injection of placebo matched to SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.2 mg/kg n=5 Participants Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.5 mg/kg n=5 Participants Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 1 mg/kg n=5 Participants Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 2 mg/kg n=5 Participants Participants received single SC injection of 2 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 4 mg/kg Participants received single SC injection of 4 mg/kg SHP681 in the abdomen on Day 1.	Part 2: Multiple Ascending Dose (MAD): 4 mg/kg (Q2W) Participants received SC injection of placebo matched to SHP681 twice weekly (Q2W) for 5 weeks in the abdomen up to Day 29.
First Order Rate Constant Associated With the Terminal (Log-linear) Portion of the Curve (Lambda z) of SHP681 During Single Ascending Dose (SAD)	0.008156 One per hour (1/h) Geometric Coefficient of Variation 23.6	0.007907 One per hour (1/h) Geometric Coefficient of Variation 14.2	0.006945 One per hour (1/h) Geometric Coefficient of Variation 12.8	0.007050 One per hour (1/h) Geometric Coefficient of Variation 10.4	0.007011 One per hour (1/h) Geometric Coefficient of Variation 15.2	—	—

SECONDARY outcome

Timeframe: Pre-dose, 3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 hours post-dose

Population: PK analysis set consisted of participants who received at least 1 dose of SHP681 and had at least 1 evaluable post-dose PK concentration value which was evaluable and interpretable.

CL/F of SHP681 during SAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.

Outcome measures

Outcome measures
Measure	Part 1: Single Ascending Dose (SAD): Placebo n=5 Participants Participants received single subcutaneous (SC) injection of placebo matched to SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.2 mg/kg n=5 Participants Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.5 mg/kg n=5 Participants Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 1 mg/kg n=5 Participants Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 2 mg/kg n=5 Participants Participants received single SC injection of 2 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 4 mg/kg Participants received single SC injection of 4 mg/kg SHP681 in the abdomen on Day 1.	Part 2: Multiple Ascending Dose (MAD): 4 mg/kg (Q2W) Participants received SC injection of placebo matched to SHP681 twice weekly (Q2W) for 5 weeks in the abdomen up to Day 29.
Apparent Total Body Clearance for Extravascular Administration Divided by the Fraction of Dose Absorbed Calculated as Dose Divided by AUC0-inf (CL/F) of SHP681 During Single Ascending Dose (SAD)	0.09810 Liter per hour (L/h) Geometric Coefficient of Variation 22.6	0.1188 Liter per hour (L/h) Geometric Coefficient of Variation 42.9	0.08856 Liter per hour (L/h) Geometric Coefficient of Variation 20.6	0.09909 Liter per hour (L/h) Geometric Coefficient of Variation 33.7	0.09689 Liter per hour (L/h) Geometric Coefficient of Variation 25.0	—	—

SECONDARY outcome

Timeframe: Pre-dose, 3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 hours post-dose

Population: PK analysis set consisted of participants who received at least 1 dose of SHP681 and had at least 1 evaluable post-dose PK concentration value which was evaluable and interpretable.

Vz/F of SHP681 during SAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.

Outcome measures

Outcome measures
Measure	Part 1: Single Ascending Dose (SAD): Placebo n=5 Participants Participants received single subcutaneous (SC) injection of placebo matched to SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.2 mg/kg n=5 Participants Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.5 mg/kg n=5 Participants Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 1 mg/kg n=5 Participants Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 2 mg/kg n=5 Participants Participants received single SC injection of 2 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 4 mg/kg Participants received single SC injection of 4 mg/kg SHP681 in the abdomen on Day 1.	Part 2: Multiple Ascending Dose (MAD): 4 mg/kg (Q2W) Participants received SC injection of placebo matched to SHP681 twice weekly (Q2W) for 5 weeks in the abdomen up to Day 29.
Apparent Volume of Distribution Following Extravascular Administration Divided by the Fraction of Dose Absorbed Calculated as CL/F Divided by Lambda z (Vz/F) of SHP681 During Single Ascending Dose (SAD)	12.01 Liter Geometric Coefficient of Variation 37.2	15.02 Liter Geometric Coefficient of Variation 54.7	12.75 Liter Geometric Coefficient of Variation 27.8	14.05 Liter Geometric Coefficient of Variation 35.8	12.98 Liter Geometric Coefficient of Variation 27.2	—	—

SECONDARY outcome

Timeframe: 3, 6, 12, 24 hours post-dose on Day 1

Population: PK analysis set consisted of participants who received at least 1 dose of SHP681 and had at least 1 evaluable post-dose PK concentration value which was evaluable and interpretable.

Cavg,0-24 of SHP681 post first dose during MAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.

Outcome measures

Outcome measures
Measure	Part 1: Single Ascending Dose (SAD): Placebo n=10 Participants Participants received single subcutaneous (SC) injection of placebo matched to SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.2 mg/kg n=10 Participants Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.5 mg/kg n=10 Participants Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 1 mg/kg n=10 Participants Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 2 mg/kg n=10 Participants Participants received single SC injection of 2 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 4 mg/kg n=10 Participants Participants received single SC injection of 4 mg/kg SHP681 in the abdomen on Day 1.	Part 2: Multiple Ascending Dose (MAD): 4 mg/kg (Q2W) Participants received SC injection of placebo matched to SHP681 twice weekly (Q2W) for 5 weeks in the abdomen up to Day 29.
Average Concentration From Time Zero to 24 Hours Post First Dose (Cavg,0-24) of SHP681 Post First Dose During Multiple Ascending Dose (MAD)	0.1716 mcg/mL Geometric Coefficient of Variation 77.2	0.5091 mcg/mL Geometric Coefficient of Variation 69.5	1.610 mcg/mL Geometric Coefficient of Variation 72.0	2.108 mcg/mL Geometric Coefficient of Variation 39.2	4.598 mcg/mL Geometric Coefficient of Variation 40.4	5.660 mcg/mL Geometric Coefficient of Variation 60.7	—

SECONDARY outcome

Timeframe: Pre-dose on Days 8, 15, 22 and 29

Population: PK analysis set consisted of participants who received at least 1 dose of SHP681 and had at least 1 evaluable post-dose PK concentration value which was evaluable and interpretable. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure at the specific categories.

Ctrough of SHP681 for the First 5 cohorts and immediately before 2nd and 3rd dose of the 6th MAD cohort during MAD was reported.

Outcome measures

Outcome measures
Measure	Part 1: Single Ascending Dose (SAD): Placebo n=10 Participants Participants received single subcutaneous (SC) injection of placebo matched to SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.2 mg/kg n=10 Participants Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.5 mg/kg n=10 Participants Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 1 mg/kg n=10 Participants Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 2 mg/kg n=10 Participants Participants received single SC injection of 2 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 4 mg/kg n=9 Participants Participants received single SC injection of 4 mg/kg SHP681 in the abdomen on Day 1.	Part 2: Multiple Ascending Dose (MAD): 4 mg/kg (Q2W) Participants received SC injection of placebo matched to SHP681 twice weekly (Q2W) for 5 weeks in the abdomen up to Day 29.
Observed Concentration at the End of Each Dosing Interval (Immediately Before Next Dose) (Ctrough) of SHP681 for the First 5 Cohorts and Immediately Before 2nd and 3rd Dose of the 6th MAD Cohort During Multiple Ascending Dose (MAD) Day 15	0.4688 mcg/mL Geometric Coefficient of Variation 27.7	1.182 mcg/mL Geometric Coefficient of Variation 30.6	2.332 mcg/mL Geometric Coefficient of Variation 20.6	5.312 mcg/mL Geometric Coefficient of Variation 14.6	9.888 mcg/mL Geometric Coefficient of Variation 28.5	2.931 mcg/mL Geometric Coefficient of Variation 22.9	—
Observed Concentration at the End of Each Dosing Interval (Immediately Before Next Dose) (Ctrough) of SHP681 for the First 5 Cohorts and Immediately Before 2nd and 3rd Dose of the 6th MAD Cohort During Multiple Ascending Dose (MAD) Day 22	0.4593 mcg/mL Geometric Coefficient of Variation 26.5	1.146 mcg/mL Geometric Coefficient of Variation 25.1	2.707 mcg/mL Geometric Coefficient of Variation 12.3	5.249 mcg/mL Geometric Coefficient of Variation 18.8	13.09 mcg/mL Geometric Coefficient of Variation 23.0	—	—
Observed Concentration at the End of Each Dosing Interval (Immediately Before Next Dose) (Ctrough) of SHP681 for the First 5 Cohorts and Immediately Before 2nd and 3rd Dose of the 6th MAD Cohort During Multiple Ascending Dose (MAD) Day 29	0.5288 mcg/mL Geometric Coefficient of Variation 24.8	1.203 mcg/mL Geometric Coefficient of Variation 25.8	2.659 mcg/mL Geometric Coefficient of Variation 14.4	5.775 mcg/mL Geometric Coefficient of Variation 27.4	12.92 mcg/mL Geometric Coefficient of Variation 26.7	3.109 mcg/mL Geometric Coefficient of Variation 22.3	—
Observed Concentration at the End of Each Dosing Interval (Immediately Before Next Dose) (Ctrough) of SHP681 for the First 5 Cohorts and Immediately Before 2nd and 3rd Dose of the 6th MAD Cohort During Multiple Ascending Dose (MAD) Day 8	0.3523 mcg/mL Geometric Coefficient of Variation 39.2	0.8432 mcg/mL Geometric Coefficient of Variation 28.2	1.754 mcg/mL Geometric Coefficient of Variation 11.9	4.062 mcg/mL Geometric Coefficient of Variation 23.5	6.949 mcg/mL Geometric Coefficient of Variation 20.9	—	—

SECONDARY outcome

Timeframe: 3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 and up to 768 hours post--dose on Day 29

Cmax of SHP681 post fifth dose during MAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.

Outcome measures

Outcome measures
Measure	Part 1: Single Ascending Dose (SAD): Placebo n=10 Participants Participants received single subcutaneous (SC) injection of placebo matched to SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.2 mg/kg n=10 Participants Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.5 mg/kg n=8 Participants Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 1 mg/kg n=9 Participants Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 2 mg/kg n=10 Participants Participants received single SC injection of 2 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 4 mg/kg n=9 Participants Participants received single SC injection of 4 mg/kg SHP681 in the abdomen on Day 1.	Part 2: Multiple Ascending Dose (MAD): 4 mg/kg (Q2W) Participants received SC injection of placebo matched to SHP681 twice weekly (Q2W) for 5 weeks in the abdomen up to Day 29.
Maximum Concentration During the Dosing Interval Occurring at Tmax (Cmax) of SHP681 Post Fifth Dose During Multiple Ascending Dose (MAD)	0.9710 mcg/mL Geometric Coefficient of Variation 38.0	2.215 mcg/mL Geometric Coefficient of Variation 39.5	4.819 mcg/mL Geometric Coefficient of Variation 19.6	10.38 mcg/mL Geometric Coefficient of Variation 34.3	24.15 mcg/mL Geometric Coefficient of Variation 28.2	14.45 mcg/mL Geometric Coefficient of Variation 31.5	—

SECONDARY outcome

Timeframe: 3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 and up to 768 hours post--dose on Day 29

Tlast of SHP681 post fifth dose during MAD was reported.

Outcome measures

Outcome measures
Measure	Part 1: Single Ascending Dose (SAD): Placebo n=10 Participants Participants received single subcutaneous (SC) injection of placebo matched to SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.2 mg/kg n=10 Participants Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.5 mg/kg n=8 Participants Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 1 mg/kg n=9 Participants Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 2 mg/kg n=10 Participants Participants received single SC injection of 2 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 4 mg/kg n=9 Participants Participants received single SC injection of 4 mg/kg SHP681 in the abdomen on Day 1.	Part 2: Multiple Ascending Dose (MAD): 4 mg/kg (Q2W) Participants received SC injection of placebo matched to SHP681 twice weekly (Q2W) for 5 weeks in the abdomen up to Day 29.
Time of the Last Measurable Concentration (Tlast) of SHP681 Post Fifth Dose During Multiple Ascending Dose (MAD)	504.0 Hour Interval 504.0 to 672.0	672.0 Hour Interval 503.0 to 674.0	672.5 Hour Interval 669.0 to 674.0	672.0 Hour Interval 672.0 to 673.0	672.0 Hour Interval 647.0 to 672.0	672.0 Hour Interval 623.0 to 768.0	—

SECONDARY outcome

Timeframe: 3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 and up to 768 hours post--dose on Day 29

tmax of SHP681 post fifth dose during MAD was reported.

Outcome measures

Outcome measures
Measure	Part 1: Single Ascending Dose (SAD): Placebo n=10 Participants Participants received single subcutaneous (SC) injection of placebo matched to SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.2 mg/kg n=10 Participants Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.5 mg/kg n=8 Participants Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 1 mg/kg n=9 Participants Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 2 mg/kg n=10 Participants Participants received single SC injection of 2 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 4 mg/kg n=9 Participants Participants received single SC injection of 4 mg/kg SHP681 in the abdomen on Day 1.	Part 2: Multiple Ascending Dose (MAD): 4 mg/kg (Q2W) Participants received SC injection of placebo matched to SHP681 twice weekly (Q2W) for 5 weeks in the abdomen up to Day 29.
Time of Maximum Observed Concentration Sampled During a Dosing Interval (Tmax) of SHP681 Post Fifth Dose During Multiple Ascending Dose (MAD)	72.00 Hour Interval 12.0 to 168.0	36.00 Hour Interval 3.0 to 96.0	48.00 Hour Interval 24.0 to 96.0	48.00 Hour Interval 12.0 to 72.0	48.00 Hour Interval 48.0 to 72.0	72.00 Hour Interval 48.0 to 96.0	—

SECONDARY outcome

Timeframe: 3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 and up to 768 hours post--dose on Day 29

AUC0-tau of SHP681 post fifth dose during MAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.

Outcome measures

Outcome measures
Measure	Part 1: Single Ascending Dose (SAD): Placebo n=10 Participants Participants received single subcutaneous (SC) injection of placebo matched to SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.2 mg/kg n=10 Participants Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.5 mg/kg n=8 Participants Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 1 mg/kg n=9 Participants Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 2 mg/kg n=10 Participants Participants received single SC injection of 2 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 4 mg/kg n=9 Participants Participants received single SC injection of 4 mg/kg SHP681 in the abdomen on Day 1.	Part 2: Multiple Ascending Dose (MAD): 4 mg/kg (Q2W) Participants received SC injection of placebo matched to SHP681 twice weekly (Q2W) for 5 weeks in the abdomen up to Day 29.
Area Under the Curve for the Defined Interval Between Doses (Only Calculated if Interpretable) (AUC0-tau) of SHP681 Post Fifth Dose During Multiple Ascending Dose (MAD)	129.6 h*mcg/mL Geometric Coefficient of Variation 33.2	282.1 h*mcg/mL Geometric Coefficient of Variation 36.2	645.2 h*mcg/mL Geometric Coefficient of Variation 18.7	1344 h*mcg/mL Geometric Coefficient of Variation 32.6	3297 h*mcg/mL Geometric Coefficient of Variation 24.8	2816 h*mcg/mL Geometric Coefficient of Variation 25.9	—

SECONDARY outcome

Timeframe: 3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 and up to 768 hours post--dose on Day 29

AUC0-last of SHP681 post fifth dose during MAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.

Outcome measures

Outcome measures
Measure	Part 1: Single Ascending Dose (SAD): Placebo n=10 Participants Participants received single subcutaneous (SC) injection of placebo matched to SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.2 mg/kg n=10 Participants Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.5 mg/kg n=8 Participants Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 1 mg/kg n=9 Participants Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 2 mg/kg n=10 Participants Participants received single SC injection of 2 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 4 mg/kg n=9 Participants Participants received single SC injection of 4 mg/kg SHP681 in the abdomen on Day 1.	Part 2: Multiple Ascending Dose (MAD): 4 mg/kg (Q2W) Participants received SC injection of placebo matched to SHP681 twice weekly (Q2W) for 5 weeks in the abdomen up to Day 29.
Area Under the Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-last) of SHP681 Post Fifth Dose During Multiple Ascending Dose (MAD)	197.8 h*mcg/mL Geometric Coefficient of Variation 29.1	435.2 h*mcg/mL Geometric Coefficient of Variation 33.8	991.4 h*mcg/mL Geometric Coefficient of Variation 16.3	2177 h*mcg/mL Geometric Coefficient of Variation 29.9	5456 h*mcg/mL Geometric Coefficient of Variation 22.8	3230 h*mcg/mL Geometric Coefficient of Variation 24.7	—

SECONDARY outcome

Timeframe: 3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 and up to 768 hours post--dose on Day 29

AUC0-inf of SHP681 post fifth dose during MAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.

Outcome measures

Outcome measures
Measure	Part 1: Single Ascending Dose (SAD): Placebo n=10 Participants Participants received single subcutaneous (SC) injection of placebo matched to SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.2 mg/kg n=10 Participants Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.5 mg/kg n=8 Participants Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 1 mg/kg n=9 Participants Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 2 mg/kg n=10 Participants Participants received single SC injection of 2 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 4 mg/kg n=9 Participants Participants received single SC injection of 4 mg/kg SHP681 in the abdomen on Day 1.	Part 2: Multiple Ascending Dose (MAD): 4 mg/kg (Q2W) Participants received SC injection of placebo matched to SHP681 twice weekly (Q2W) for 5 weeks in the abdomen up to Day 29.
Area Under the Curve Extrapolated to Infinity (AUC0-inf) of SHP681 Post Fifth Dose During Multiple Ascending Dose (MAD)	203.4 h*mcg/mL Geometric Coefficient of Variation 28.5	443.1 h*mcg/mL Geometric Coefficient of Variation 33.5	1006 h*mcg/mL Geometric Coefficient of Variation 16.3	2216 h*mcg/mL Geometric Coefficient of Variation 29.6	5548 h*mcg/mL Geometric Coefficient of Variation 22.8	3277 h*mcg/mL Geometric Coefficient of Variation 24.5	—

SECONDARY outcome

Timeframe: 3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 and up to 768 hours post--dose on Day 29

Cavg,0-24 of SHP681 during MAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.

Outcome measures

Outcome measures
Measure	Part 1: Single Ascending Dose (SAD): Placebo n=10 Participants Participants received single subcutaneous (SC) injection of placebo matched to SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.2 mg/kg n=10 Participants Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.5 mg/kg n=8 Participants Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 1 mg/kg n=9 Participants Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 2 mg/kg n=10 Participants Participants received single SC injection of 2 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 4 mg/kg n=9 Participants Participants received single SC injection of 4 mg/kg SHP681 in the abdomen on Day 1.	Part 2: Multiple Ascending Dose (MAD): 4 mg/kg (Q2W) Participants received SC injection of placebo matched to SHP681 twice weekly (Q2W) for 5 weeks in the abdomen up to Day 29.
Average Concentration From Time Zero to 24 Hours Post Dose (Cavg,0-24) of SHP681 During Multiple Ascending Dose (MAD)	0.6956 mcg/mL Geometric Coefficient of Variation 42.3	1.683 mcg/mL Geometric Coefficient of Variation 36.9	3.619 mcg/mL Geometric Coefficient of Variation 20.8	7.942 mcg/mL Geometric Coefficient of Variation 22.3	17.04 mcg/mL Geometric Coefficient of Variation 23.4	7.006 mcg/mL Geometric Coefficient of Variation 35.9	—

SECONDARY outcome

Timeframe: 3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 and up to 768 hours post--dose on Day 29

t1/2 of SHP681 post fifth dose during MAD was reported.

Outcome measures

Outcome measures
Measure	Part 1: Single Ascending Dose (SAD): Placebo n=10 Participants Participants received single subcutaneous (SC) injection of placebo matched to SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.2 mg/kg n=10 Participants Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.5 mg/kg n=8 Participants Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 1 mg/kg n=9 Participants Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 2 mg/kg n=10 Participants Participants received single SC injection of 2 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 4 mg/kg n=9 Participants Participants received single SC injection of 4 mg/kg SHP681 in the abdomen on Day 1.	Part 2: Multiple Ascending Dose (MAD): 4 mg/kg (Q2W) Participants received SC injection of placebo matched to SHP681 twice weekly (Q2W) for 5 weeks in the abdomen up to Day 29.
Terminal Half-life (t1/2) of SHP681 Post Fifth Dose During Multiple Ascending Dose (MAD)	96.30 Hour Interval 82.6 to 116.0	108.5 Hour Interval 81.3 to 130.0	103.5 Hour Interval 96.6 to 116.0	105.0 Hour Interval 98.2 to 131.0	106.5 Hour Interval 96.4 to 131.0	99.10 Hour Interval 92.3 to 110.0	—

SECONDARY outcome

Timeframe: 3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 and up to 768 hours post--dose on Day 29

Lambda z of SHP681 post fifth dose during MAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.

Outcome measures

Outcome measures
Measure	Part 1: Single Ascending Dose (SAD): Placebo n=10 Participants Participants received single subcutaneous (SC) injection of placebo matched to SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.2 mg/kg n=10 Participants Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.5 mg/kg n=8 Participants Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 1 mg/kg n=9 Participants Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 2 mg/kg n=10 Participants Participants received single SC injection of 2 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 4 mg/kg n=9 Participants Participants received single SC injection of 4 mg/kg SHP681 in the abdomen on Day 1.	Part 2: Multiple Ascending Dose (MAD): 4 mg/kg (Q2W) Participants received SC injection of placebo matched to SHP681 twice weekly (Q2W) for 5 weeks in the abdomen up to Day 29.
First Order Rate Constant Associated With the Terminal (Log-linear) Portion of the Curve (Lambda z) of SHP681 Post Fifth Dose During Multiple Ascending Dose (MAD)	0.007215 1/h Geometric Coefficient of Variation 9.4	0.006667 1/h Geometric Coefficient of Variation 14.3	0.006633 1/h Geometric Coefficient of Variation 6.3	0.006416 1/h Geometric Coefficient of Variation 8.7	0.006473 1/h Geometric Coefficient of Variation 9.8	0.006922 1/h Geometric Coefficient of Variation 5.5	—

SECONDARY outcome

Timeframe: 3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 and up to 768 hours post--dose on Day 29

CL/F of SHP681 post fifth dose during MAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.

Outcome measures

Outcome measures
Measure	Part 1: Single Ascending Dose (SAD): Placebo n=10 Participants Participants received single subcutaneous (SC) injection of placebo matched to SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.2 mg/kg n=10 Participants Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.5 mg/kg n=8 Participants Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 1 mg/kg n=9 Participants Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 2 mg/kg n=10 Participants Participants received single SC injection of 2 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 4 mg/kg n=9 Participants Participants received single SC injection of 4 mg/kg SHP681 in the abdomen on Day 1.	Part 2: Multiple Ascending Dose (MAD): 4 mg/kg (Q2W) Participants received SC injection of placebo matched to SHP681 twice weekly (Q2W) for 5 weeks in the abdomen up to Day 29.
Apparent Total Body Clearance Following Extravascular Administration Divided by the Fraction of Dose Absorbed Calculated as Dose Divided by AUCtau (CL/F) of SHP681 Post Fifth Dose During Multiple Ascending Dose (MAD)	0.1225 L/h Geometric Coefficient of Variation 38.5	0.1366 L/h Geometric Coefficient of Variation 53.5	0.1141 L/h Geometric Coefficient of Variation 21.3	0.1226 L/h Geometric Coefficient of Variation 35.5	0.09547 L/h Geometric Coefficient of Variation 27.3	0.1100 L/h Geometric Coefficient of Variation 19.6	—

SECONDARY outcome

Timeframe: 3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 and up to 768 hours post--dose on Day 29

Vz/F of SHP681 post fifth dose during MAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.

Outcome measures

Outcome measures
Measure	Part 1: Single Ascending Dose (SAD): Placebo n=10 Participants Participants received single subcutaneous (SC) injection of placebo matched to SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.2 mg/kg n=10 Participants Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.5 mg/kg n=8 Participants Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 1 mg/kg n=9 Participants Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 2 mg/kg n=10 Participants Participants received single SC injection of 2 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 4 mg/kg n=9 Participants Participants received single SC injection of 4 mg/kg SHP681 in the abdomen on Day 1.	Part 2: Multiple Ascending Dose (MAD): 4 mg/kg (Q2W) Participants received SC injection of placebo matched to SHP681 twice weekly (Q2W) for 5 weeks in the abdomen up to Day 29.
Apparent Volume of Distribution Following Extravascular Administration Divided by the Fraction of Dose Absorbed Calculated as CL/F Divided by Lambda z (Vz/F) of SHP681 Post Fifth Dose During Multiple Ascending Dose (MAD)	16.99 Liter Geometric Coefficient of Variation 39.4	20.48 Liter Geometric Coefficient of Variation 56.4	17.21 Liter Geometric Coefficient of Variation 24.0	19.12 Liter Geometric Coefficient of Variation 42.2	14.75 Liter Geometric Coefficient of Variation 30.8	15.89 Liter Geometric Coefficient of Variation 17.8	—

Adverse Events

Part 1: Single Ascending Dose (SAD): Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 1: Single Ascending Dose (SAD): 0.2 mg/kg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 1: Single Ascending Dose (SAD): 0.5 mg/kg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 1: Single Ascending Dose (SAD): 1 mg/kg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Part 1: Single Ascending Dose (SAD): 2 mg/kg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 1: Single Ascending Dose (SAD): 4 mg/kg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 2: Multiple Ascending Dose (MAD): Placebo

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Part 2: Multiple Ascending Dose (MAD): 0.2 mg/kg

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Part 2: Multiple Ascending Dose (MAD): 0.5 mg/kg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 2: Multiple Ascending Dose (MAD): 1 mg/kg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Part 2: Multiple Ascending Dose (MAD): 2 mg/kg

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Part 2: Multiple Ascending Dose (MAD): 4 mg/kg

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Part 2: Multiple Ascending Dose (MAD): 4 mg/kg (Q2W)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part 1: Single Ascending Dose (SAD): Placebo n=5 participants at risk Participants received single subcutaneous (SC) injection of placebo matched to SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.2 mg/kg n=5 participants at risk Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.5 mg/kg n=5 participants at risk Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 1 mg/kg n=5 participants at risk Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 2 mg/kg n=5 participants at risk Participants received single SC injection of 2 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 4 mg/kg n=5 participants at risk Participants received single SC injection of 4 mg/kg SHP681 in the abdomen on Day 1.	Part 2: Multiple Ascending Dose (MAD): Placebo n=12 participants at risk Participants received SC injection of placebo matched to SHP681 once weekly for 5 weeks in the abdomen up to Day 29.	Part 2: Multiple Ascending Dose (MAD): 0.2 mg/kg n=10 participants at risk Participants received SC injection of 0.2 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.	Part 2: Multiple Ascending Dose (MAD): 0.5 mg/kg n=10 participants at risk Participants received SC injection of 0.5 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.	Part 2: Multiple Ascending Dose (MAD): 1 mg/kg n=10 participants at risk Participants received SC injection of 1 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.	Part 2: Multiple Ascending Dose (MAD): 2 mg/kg n=10 participants at risk Participants received SC injection of 2 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.	Part 2: Multiple Ascending Dose (MAD): 4 mg/kg n=12 participants at risk Participants received SC injection of 4 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.	Part 2: Multiple Ascending Dose (MAD): 4 mg/kg (Q2W) n=10 participants at risk Participants received SC injection of placebo matched to SHP681 twice weekly (Q2W) for 5 weeks in the abdomen up to Day 29.
Hepatobiliary disorders Cholecystitis	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	10.0% 1/10 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)
Hepatobiliary disorders Hepatocellular injury	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	10.0% 1/10 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)

Other adverse events

Other adverse events
Measure	Part 1: Single Ascending Dose (SAD): Placebo n=5 participants at risk Participants received single subcutaneous (SC) injection of placebo matched to SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.2 mg/kg n=5 participants at risk Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 0.5 mg/kg n=5 participants at risk Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 1 mg/kg n=5 participants at risk Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 2 mg/kg n=5 participants at risk Participants received single SC injection of 2 mg/kg SHP681 in the abdomen on Day 1.	Part 1: Single Ascending Dose (SAD): 4 mg/kg n=5 participants at risk Participants received single SC injection of 4 mg/kg SHP681 in the abdomen on Day 1.	Part 2: Multiple Ascending Dose (MAD): Placebo n=12 participants at risk Participants received SC injection of placebo matched to SHP681 once weekly for 5 weeks in the abdomen up to Day 29.	Part 2: Multiple Ascending Dose (MAD): 0.2 mg/kg n=10 participants at risk Participants received SC injection of 0.2 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.	Part 2: Multiple Ascending Dose (MAD): 0.5 mg/kg n=10 participants at risk Participants received SC injection of 0.5 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.	Part 2: Multiple Ascending Dose (MAD): 1 mg/kg n=10 participants at risk Participants received SC injection of 1 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.	Part 2: Multiple Ascending Dose (MAD): 2 mg/kg n=10 participants at risk Participants received SC injection of 2 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.	Part 2: Multiple Ascending Dose (MAD): 4 mg/kg n=12 participants at risk Participants received SC injection of 4 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.	Part 2: Multiple Ascending Dose (MAD): 4 mg/kg (Q2W) n=10 participants at risk Participants received SC injection of placebo matched to SHP681 twice weekly (Q2W) for 5 weeks in the abdomen up to Day 29.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	10.0% 1/10 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)
Gastrointestinal disorders Abdominal distension	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	20.0% 2/10 • Number of events 2 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	10.0% 1/10 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)
Gastrointestinal disorders Abdominal pain upper	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	10.0% 1/10 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	16.7% 2/12 • Number of events 3 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)
Gastrointestinal disorders Constipation	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	10.0% 1/10 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	10.0% 1/10 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	20.0% 2/10 • Number of events 2 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	8.3% 1/12 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	10.0% 1/10 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)
Gastrointestinal disorders Diarrhoea	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	10.0% 1/10 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)
Gastrointestinal disorders Dyspepsia	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	10.0% 1/10 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)
Gastrointestinal disorders Faeces hard	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	8.3% 1/12 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	20.0% 2/10 • Number of events 2 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)
Gastrointestinal disorders Flatulence	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	8.3% 1/12 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)
Gastrointestinal disorders Gastrointestinal motility disorder	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	10.0% 1/10 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)
Gastrointestinal disorders Gastrointestinal sounds abnormal	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	8.3% 1/12 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	10.0% 1/10 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	30.0% 3/10 • Number of events 4 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	8.3% 1/12 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	10.0% 1/10 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)
Gastrointestinal disorders Hiatus hernia	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	10.0% 1/10 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	8.3% 1/12 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)
Gastrointestinal disorders Nausea	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	20.0% 1/5 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	16.7% 2/12 • Number of events 4 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	20.0% 2/10 • Number of events 2 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	10.0% 1/10 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	20.0% 2/10 • Number of events 2 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	33.3% 4/12 • Number of events 8 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)
Gastrointestinal disorders Oesophagitis	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	10.0% 1/10 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)
Gastrointestinal disorders Proctalgia	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	10.0% 1/10 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)
Gastrointestinal disorders Vomiting	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	20.0% 1/5 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	16.7% 2/12 • Number of events 3 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	10.0% 1/10 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	16.7% 2/12 • Number of events 6 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)
General disorders Application site irritation	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	8.3% 1/12 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)
General disorders Asthenia	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	8.3% 1/12 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)
General disorders Fatigue	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	10.0% 1/10 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	8.3% 1/12 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)
General disorders Injection site bruising	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	8.3% 1/12 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	20.0% 2/10 • Number of events 2 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	10.0% 1/10 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)
General disorders Pyrexia	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	10.0% 1/10 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)
Hepatobiliary disorders Cholelithiasis	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	8.3% 1/12 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	60.0% 6/10 • Number of events 6 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)
Infections and infestations Nasopharyngitis	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	8.3% 1/12 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)
Infections and infestations Oral herpes	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	10.0% 1/10 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)
Injury, poisoning and procedural complications Contusion	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	20.0% 1/5 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	8.3% 1/12 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	10.0% 1/10 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	20.0% 2/10 • Number of events 2 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)
Injury, poisoning and procedural complications Procedural dizziness	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	10.0% 1/10 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	8.3% 1/12 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)
Injury, poisoning and procedural complications Procedural nausea	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	8.3% 1/12 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	8.3% 1/12 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)
Investigations Alanine aminotransferase increased	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	10.0% 1/10 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)
Investigations Amylase increased	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	20.0% 1/5 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	20.0% 1/5 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)
Investigations Blood thyroid stimulating hormone increased	60.0% 3/5 • Number of events 4 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	40.0% 2/5 • Number of events 2 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	20.0% 1/5 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	60.0% 3/5 • Number of events 4 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	60.0% 3/5 • Number of events 3 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	20.0% 1/5 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)
Investigations Lipase increased	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	20.0% 1/5 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)
Metabolism and nutrition disorders Polydipsia	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	8.3% 1/12 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	10.0% 1/10 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)
Nervous system disorders Dizziness	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	20.0% 1/5 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	8.3% 1/12 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	8.3% 1/12 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)
Nervous system disorders Headache	20.0% 1/5 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	8.3% 1/12 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	20.0% 2/10 • Number of events 4 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	10.0% 1/10 • Number of events 2 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	10.0% 1/10 • Number of events 2 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	25.0% 3/12 • Number of events 3 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	10.0% 1/10 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	10.0% 1/10 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	8.3% 1/12 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	10.0% 1/10 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	10.0% 1/10 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)
Respiratory, thoracic and mediastinal disorders Paranasal sinus discomfort	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	8.3% 1/12 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	10.0% 1/10 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)
Skin and subcutaneous tissue disorders Erythema	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	10.0% 1/10 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)
Skin and subcutaneous tissue disorders Macule	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	8.3% 1/12 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	8.3% 1/12 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)
Skin and subcutaneous tissue disorders Pruritus generalised	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	8.3% 1/12 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	10.0% 1/10 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)
Skin and subcutaneous tissue disorders Skin irritation	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	20.0% 1/5 • Number of events 2 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/5 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/10 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	0.00% 0/12 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)	10.0% 1/10 • Number of events 1 • From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)

Additional Information

Study Director

Shire

Phone: +1 866 842 5335

Email: [email protected]

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