Trial Outcomes & Findings for Phase 1 Study to Assess Safety and Efficacy of ANG003 (NCT NCT06052293)
NCT ID: NCT06052293
Last Updated: 2026-04-27
Results Overview
AE, SAEs and AEs leading to study discontinuation measured by number of participants during study.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
57 participants
Primary outcome timeframe
Assessed through study completion, up to 9 days (Day 1 thru Day 9).
Results posted on
2026-04-27
Participant Flow
Participant milestones
| Measure |
ANG003 Dose Level 1
Single administration dose contains 20mg lipase, 25 mg protease and 40 mg amylase.
ANG003: To evaluate four possible combinations of lipase, protease and amylase.
|
ANG003 Dose Level 2
Single administration dose contains 40 mg lipase, 50 mg protease and 80 mg amylase.
ANG003: To evaluate four possible combinations of lipase, protease and amylase.
|
ANG003 Dose Level 3
Single administration dose contains 80 mg lipase, 50 mg protease and 80 mg amylase.
ANG003: To evaluate four possible combinations of lipase, protease and amylase.
|
ANG003 Dose Level 4
Single administration dose contains 120 mg lipase, 75 mg protease and 120 mg amylase.
ANG003: To evaluate four possible combinations of lipase, protease and amylase.
|
|---|---|---|---|---|
|
Randomized to ANG003 (Day -2)
STARTED
|
13
|
15
|
13
|
16
|
|
Randomized to ANG003 (Day -2)
COMPLETED
|
13
|
14
|
12
|
16
|
|
Randomized to ANG003 (Day -2)
NOT COMPLETED
|
0
|
1
|
1
|
0
|
|
Baseline SACT (Day 1)
STARTED
|
13
|
14
|
12
|
16
|
|
Baseline SACT (Day 1)
COMPLETED
|
13
|
13
|
12
|
16
|
|
Baseline SACT (Day 1)
NOT COMPLETED
|
0
|
1
|
0
|
0
|
|
ANG003 SACT (Day 5)
STARTED
|
13
|
13
|
12
|
13
|
|
ANG003 SACT (Day 5)
COMPLETED
|
13
|
13
|
12
|
13
|
|
ANG003 SACT (Day 5)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 1 Study to Assess Safety and Efficacy of ANG003
Baseline characteristics by cohort
| Measure |
ANG003 Dose Level 1
n=13 Participants
Single administration dose contains 20 mg lipase, 25 mg protease and 40 mg amylase.
ANG003: To evaluate four possible combinations of lipase, protease and amylase.
|
ANG003 Dose Level 2
n=13 Participants
Single administration dose contains 40 mg lipase, 50 mg protease and 80 mg amylase.
ANG003: To evaluate four possible combinations of lipase, protease and amylase.
|
ANG003 Dose Level 3
n=12 Participants
Single administration dose contains 80 mg lipase, 50 mg protease and 80 mg amylase.
ANG003: To evaluate four possible combinations of lipase, protease and amylase.
|
ANG003 Dose Level 4
n=13 Participants
Single administration dose contains 120 mg lipase, 75 mg protease and 120 mg amylase.
ANG003: To evaluate four possible combinations of lipase, protease and amylase.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Sex: Female, Male
Female
|
6 Participants
n=226 Participants
|
7 Participants
n=240 Participants
|
5 Participants
n=236 Participants
|
6 Participants
n=702 Participants
|
24 Participants
n=211 Participants
|
|
Age, Continuous
|
28.8 years
n=226 Participants
|
25.2 years
n=240 Participants
|
34.3 years
n=236 Participants
|
33.2 years
n=702 Participants
|
30.3 years
n=211 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=226 Participants
|
6 Participants
n=240 Participants
|
7 Participants
n=236 Participants
|
7 Participants
n=702 Participants
|
27 Participants
n=211 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=226 Participants
|
2 Participants
n=240 Participants
|
1 Participants
n=236 Participants
|
0 Participants
n=702 Participants
|
3 Participants
n=211 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=226 Participants
|
10 Participants
n=240 Participants
|
11 Participants
n=236 Participants
|
13 Participants
n=702 Participants
|
47 Participants
n=211 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=226 Participants
|
1 Participants
n=240 Participants
|
0 Participants
n=236 Participants
|
0 Participants
n=702 Participants
|
1 Participants
n=211 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=226 Participants
|
0 Participants
n=240 Participants
|
0 Participants
n=236 Participants
|
0 Participants
n=702 Participants
|
0 Participants
n=211 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=226 Participants
|
0 Participants
n=240 Participants
|
0 Participants
n=236 Participants
|
0 Participants
n=702 Participants
|
0 Participants
n=211 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=226 Participants
|
0 Participants
n=240 Participants
|
0 Participants
n=236 Participants
|
0 Participants
n=702 Participants
|
0 Participants
n=211 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=226 Participants
|
0 Participants
n=240 Participants
|
0 Participants
n=236 Participants
|
1 Participants
n=702 Participants
|
1 Participants
n=211 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=226 Participants
|
11 Participants
n=240 Participants
|
12 Participants
n=236 Participants
|
12 Participants
n=702 Participants
|
48 Participants
n=211 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=226 Participants
|
0 Participants
n=240 Participants
|
0 Participants
n=236 Participants
|
0 Participants
n=702 Participants
|
0 Participants
n=211 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=226 Participants
|
2 Participants
n=240 Participants
|
0 Participants
n=236 Participants
|
0 Participants
n=702 Participants
|
2 Participants
n=211 Participants
|
|
Cystic fibrosis transmembrane conductance regulator (CFTR) Modulator Therapy
Yes
|
13 Participants
n=226 Participants
|
12 Participants
n=240 Participants
|
10 Participants
n=236 Participants
|
12 Participants
n=702 Participants
|
47 Participants
n=211 Participants
|
|
Cystic fibrosis transmembrane conductance regulator (CFTR) Modulator Therapy
No
|
0 Participants
n=226 Participants
|
1 Participants
n=240 Participants
|
2 Participants
n=236 Participants
|
1 Participants
n=702 Participants
|
4 Participants
n=211 Participants
|
|
Diabetes
Yes
|
3 Participants
n=226 Participants
|
1 Participants
n=240 Participants
|
7 Participants
n=236 Participants
|
6 Participants
n=702 Participants
|
17 Participants
n=211 Participants
|
|
Diabetes
No
|
10 Participants
n=226 Participants
|
12 Participants
n=240 Participants
|
5 Participants
n=236 Participants
|
7 Participants
n=702 Participants
|
34 Participants
n=211 Participants
|
|
Body Mass Index (BMI)
|
23.7 kg/m^2
n=226 Participants
|
23.01 kg/m^2
n=240 Participants
|
25.3 kg/m^2
n=236 Participants
|
25.3 kg/m^2
n=702 Participants
|
24.3 kg/m^2
n=211 Participants
|
PRIMARY outcome
Timeframe: Assessed through study completion, up to 9 days (Day 1 thru Day 9).AE, SAEs and AEs leading to study discontinuation measured by number of participants during study.
Outcome measures
| Measure |
ANG003 Dose Level 3
n=12 Participants
Single administration dose contains 80 mg lipase, 50 mg protease and 80 mg amylase.
ANG003: To evaluate four possible combinations of lipase, protease and amylase.
|
ANG003 Dose Level 4
n=13 Participants
Single administration dose contains 120 mg lipase, 75 mg protease and 120 mg amylase.
ANG003: To evaluate four possible combinations of lipase, protease and amylase.
|
ANG003 Dose Level 1
n=13 Participants
Single administration dose contains 20 mg lipase, 25 mg protease and 40 mg amylase.
ANG003: To evaluate four possible combinations of lipase, protease and amylase.
|
ANG003 Dose Level 2
n=13 Participants
Single administration dose contains 40 mg lipase, 50 mg protease and 80 mg amylase.
ANG003: To evaluate four possible combinations of lipase, protease and amylase.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and AEs Leading to Study Discontinuation
Any SEA
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and AEs Leading to Study Discontinuation
Any Treatment-Related TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and AEs Leading to Study Discontinuation
Any AE
|
7 Participants
|
7 Participants
|
8 Participants
|
8 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed through study completion, up to 9 days (Day 1 thru Day 9).Changes in glucose (mg/dL) as measured by continuous glucose monitoring.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed through study completion, up to 9 days (Day 1 thru Day 9).Measured by changes in plasma concentration of amino acids.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: DHA+EPA measured at baseline t0, 1h, 2h, 4h, 6h, 8h, 10-12h, and 24h post on Baseline SACT (Day 1) and ANG003 SACT (Day 5)Population: DHA+EPA Cmax ANG003 SACT (Day 5) - Baseline SACT (Day 1)
Measured by concentration of plasma fatty acids.
Outcome measures
| Measure |
ANG003 Dose Level 3
n=12 Participants
Single administration dose contains 80 mg lipase, 50 mg protease and 80 mg amylase.
ANG003: To evaluate four possible combinations of lipase, protease and amylase.
|
ANG003 Dose Level 4
n=12 Participants
Single administration dose contains 120 mg lipase, 75 mg protease and 120 mg amylase.
ANG003: To evaluate four possible combinations of lipase, protease and amylase.
|
ANG003 Dose Level 1
n=13 Participants
Single administration dose contains 20 mg lipase, 25 mg protease and 40 mg amylase.
ANG003: To evaluate four possible combinations of lipase, protease and amylase.
|
ANG003 Dose Level 2
n=11 Participants
Single administration dose contains 40 mg lipase, 50 mg protease and 80 mg amylase.
ANG003: To evaluate four possible combinations of lipase, protease and amylase.
|
|---|---|---|---|---|
|
Fat Absorption Assessed as Cmax of DHA+EPA
|
33.0 ug/mL
Standard Deviation 31.3
|
43.2 ug/mL
Standard Deviation 37.2
|
9.1 ug/mL
Standard Deviation 26.3
|
9.0 ug/mL
Standard Deviation 10.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: DHA+EPA measured at baseline t0, 1h, 2h, 4h, 6h, 8h, 10-12h, and 24h post on Baseline SACT (Day 1) and ANG003 SACT (Day 5)Population: DHA+EPA Positive Peak AUC-24hr ANG003 SACT (Day 5) - Baseline SACT (Day 1)
Measured by concentration of plasma fatty acids.
Outcome measures
| Measure |
ANG003 Dose Level 3
n=12 Participants
Single administration dose contains 80 mg lipase, 50 mg protease and 80 mg amylase.
ANG003: To evaluate four possible combinations of lipase, protease and amylase.
|
ANG003 Dose Level 4
n=12 Participants
Single administration dose contains 120 mg lipase, 75 mg protease and 120 mg amylase.
ANG003: To evaluate four possible combinations of lipase, protease and amylase.
|
ANG003 Dose Level 1
n=13 Participants
Single administration dose contains 20 mg lipase, 25 mg protease and 40 mg amylase.
ANG003: To evaluate four possible combinations of lipase, protease and amylase.
|
ANG003 Dose Level 2
n=11 Participants
Single administration dose contains 40 mg lipase, 50 mg protease and 80 mg amylase.
ANG003: To evaluate four possible combinations of lipase, protease and amylase.
|
|---|---|---|---|---|
|
Fat Absorption Assessed as Area Under the Curve (AUC-24hr) of Plamsa Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA)
|
442.7 ug*hr/mL
Standard Deviation 423.0
|
559.4 ug*hr/mL
Standard Deviation 385.4
|
135.9 ug*hr/mL
Standard Deviation 313.0
|
184.5 ug*hr/mL
Standard Deviation 221.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Acute PAGI-SYM is based upon 7-day recall.Severity of malabsorption symptoms (e.g., abdominal discomfort or pain, bloating, heartburn, regurgitation or reflux, retching, stomach fullness, and vomiting) by patient reported outcome scale (0=None; 1=Very Mild; 2=Mild; 3=Moderate; 4=Severe; 5=Very Severe). Measured by 20 questions contained in Acute Patient Assessment of Gastrointestinal Symptoms (Acute PAGI-SYM) questionnaire.
Outcome measures
Outcome data not reported
Adverse Events
ANG003 Dose Level 1
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
ANG003 Dose Level 2
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
ANG003 Dose Level 3
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
ANG003 Dose Level 4
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ANG003 Dose Level 1
n=13 participants at risk
Single administration dose contains 20 mg lipase, 25 mg protease and 40 mg amylase.
ANG003: To evaluate four possible combinations of lipase, protease and amylase.
|
ANG003 Dose Level 2
n=13 participants at risk
Single administration dose contains 40 mg lipase, 50 mg protease and 80 mg amylase.
ANG003: To evaluate four possible combinations of lipase, protease and amylase.
|
ANG003 Dose Level 3
n=12 participants at risk
Single administration dose contains 80 mg lipase, 50 mg protease and 80 mg amylase.
ANG003: To evaluate four possible combinations of lipase, protease and amylase.
|
ANG003 Dose Level 4
n=13 participants at risk
Single administration dose contains 120 mg lipase, 75 mg protease and 120 mg amylase.
ANG003: To evaluate four possible combinations of lipase, protease and amylase.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Discomfort
|
15.4%
2/13 • Number of events 2 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
8.3%
1/12 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
|
Gastrointestinal disorders
Abdominal Distension
|
15.4%
2/13 • Number of events 2 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
7.7%
1/13 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
8.3%
1/12 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
7.7%
1/13 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
|
Gastrointestinal disorders
Abdominal Pain
|
23.1%
3/13 • Number of events 4 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
23.1%
3/13 • Number of events 3 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
16.7%
2/12 • Number of events 3 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
15.4%
2/13 • Number of events 3 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
7.7%
1/13 • Number of events 2 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/12 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
|
Gastrointestinal disorders
Constipation
|
7.7%
1/13 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/12 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
15.4%
2/13 • Number of events 3 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
8.3%
1/12 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
30.8%
4/13 • Number of events 5 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
|
Gastrointestinal disorders
Dyspepsia
|
15.4%
2/13 • Number of events 2 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/12 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
15.4%
2/13 • Number of events 2 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
|
Gastrointestinal disorders
Faeces Soft
|
7.7%
1/13 • Number of events 2 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
16.7%
2/12 • Number of events 2 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
7.7%
1/13 • Number of events 2 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
|
Gastrointestinal disorders
Flatulence
|
15.4%
2/13 • Number of events 2 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
8.3%
1/12 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
7.7%
1/13 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
|
Gastrointestinal disorders
Frequent Bowel Movements
|
7.7%
1/13 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
8.3%
1/12 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
|
Gastrointestinal disorders
Gastrointestinal Sounds Abnormal
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
8.3%
1/12 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
7.7%
1/13 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
16.7%
2/12 • Number of events 3 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
7.7%
1/13 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
7.7%
1/13 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/12 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
|
Gastrointestinal disorders
Nausea
|
7.7%
1/13 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
7.7%
1/13 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
16.7%
2/12 • Number of events 2 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
7.7%
1/13 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
|
Gastrointestinal disorders
Steatorrhoea
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
8.3%
1/12 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
15.4%
2/13 • Number of events 3 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/12 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
7.7%
1/13 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
|
General disorders
Infusion Site Bruising
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/12 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
7.7%
1/13 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
|
General disorders
Infusion Site Pain
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/12 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
7.7%
1/13 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
|
General disorders
Medical Device Site Phlebitis
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/12 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
7.7%
1/13 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
|
Infections and infestations
COVID-19
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/12 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
7.7%
1/13 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
|
Infections and infestations
Tinea Infection
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
8.3%
1/12 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/12 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
7.7%
1/13 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
|
Injury, poisoning and procedural complications
Procedural Vomiting
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
8.3%
1/12 • Number of events 3 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/12 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
7.7%
1/13 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
7.7%
1/13 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/12 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
7.7%
1/13 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/12 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
|
Investigations
Blood Creatine Increased
|
7.7%
1/13 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/12 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
|
Investigations
Blood Triglycerides Increased
|
7.7%
1/13 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
7.7%
1/13 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
8.3%
1/12 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
|
Investigations
Crystal Urine Present
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
7.7%
1/13 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/12 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
|
Investigations
Eosinophil Count Increased
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/12 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
7.7%
1/13 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
|
Investigations
Glucose Urine
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
7.7%
1/13 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/12 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
|
Investigations
Glycosylated Haemoglobin Increased
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
8.3%
1/12 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
7.7%
1/13 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
|
Investigations
Insulin C-peptide Increased
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
7.7%
1/13 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/12 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
|
Investigations
Low Density Lipoprotein Increased
|
7.7%
1/13 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
7.7%
1/13 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/12 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
|
Investigations
Monocyte Count Increased
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/12 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
7.7%
1/13 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
|
Investigations
Protein Urine
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
15.4%
2/13 • Number of events 2 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/12 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
|
Investigations
Protein Urine Present
|
7.7%
1/13 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/12 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
|
Investigations
Urine Ketone Body Present
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
7.7%
1/13 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/12 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
|
Investigations
Vitamin E Decreased
|
7.7%
1/13 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/12 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
|
Investigations
Vitamin K Decreased
|
7.7%
1/13 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/12 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
|
Investigations
White Blood Cell Count Decreased
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/12 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
7.7%
1/13 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
8.3%
1/12 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
7.7%
1/13 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
7.7%
1/13 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/12 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
|
Nervous system disorders
Headache
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
15.4%
2/13 • Number of events 4 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
8.3%
1/12 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
7.7%
1/13 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
7.7%
1/13 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/12 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
7.7%
1/13 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/12 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/12 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
7.7%
1/13 • Number of events 2 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
|
Vascular disorders
Flushing
|
7.7%
1/13 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/12 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
|
Vascular disorders
Orthostatic Hypotension
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/13 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
0.00%
0/12 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
7.7%
1/13 • Number of events 1 • Reporting of AEs occurred from Day 1 to Day 9/EOS
Subjects were required to be off their Standard of Care (SoC) Pancreatic Enzyme Replacement Therapy (PERT) regimen for 24 hours prior to the start of each Substrate Absorption Challenge Test (SACT) period (Day -1 and 4) and for an additional 24 hours (Day 1 and 5) during each SACT period for a total of 48 consecutive hours Off SoC PERT. Subjects received one dose of ANG003 on Day 5.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place