Acute Pancreatitis, Systemic Inflammatory Response Syndrome
Conditions
Brief summary
This open-label, dose-response study will evaluate the safety and efficacy of CM4620-IE in patients with acute pancreatitis and accompanying SIRS. The study will consist of two phases. The first phase will consist of 4 female and 4 male patients (cohorts 1 and 2, respectively), enrolled concurrently, randomized in a 3:1 ratio to receive CM4620-IE plus standard of care versus standard of care alone. Planned doses for first phase will be CM4620-IE 1.0 mg/kg on Day 1 and then 1.4 mg/kg on Days 2 - 4. The second phase will consist of 8 female and 8 male patients (cohorts 3 and 4, respectively), enrolled concurrently, randomized in a 3:1 ratio to receive CM4620-IE plus standard of care versus standard of care alone. Planned doses for second phase will be CM4620-IE 2.08 mg/kg on Days 1 and 2 and then 1.6 mg/kg on Days 3 and 4. Dose escalation to second phase would only occur if needed for efficacy reasons and if no events suggesting a safety signal would occur with higher dosing. The study is not powered for the analysis of study data with inferential statisitcs as the primary purpose of the study is to explore what endpoints would be most appropriate for future trials.
Detailed description
After review of the efficacy, tolerability and safety data from cohorts 1 and 2 by the sponsor and the United States Food and Drug Administration, the decision was made to continue the low-dose regimen (CM4620-IE 1.0 mg/kg on Day 1 and then 1.4 mg/kg on Days 2 - 4) in cohort 3. Cohort 4 received the high-dose regimen (CM4620-IE 2.08 mg/kg on Days 1 and 2 and then 1.6 mg/kg on Days 3 and 4) as planned. Efficacy analysis were combined because no dose escalation occurred in cohort 3. Patients were followed for 90 days after randomization.
Interventions
DRUGCM4620 Injectable Emulsion (Low Dose)
CM4620-IE 1.0 mg/kg on Day 1 and then 1.4 mg/kg on Days 2-4, during the first phase of the study (Cohorts 1 and 2). All doses of CM4620-IE will be administered intravenously (IV) over 4 hours.
DRUGCM4620 Injectable Emulsion (High Dose)
CM4620-IE 2.08 mg/kg on Days 1 and 2 and then 1.6 mg/kg on Days 3 and 4, during the second phase of the study (Cohorts 3 and 4). All doses of CM4620-IE will be administered intravenously (IV) over 4 hours.
Sponsors
CalciMedica, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of acute pancreatitis established by the presence of abdominal pain consistent with acute pancreatitis and 1 of the following 2 criteria: 1. Serum lipase and/or serum amylase \> 3 times the upper limit of normal (ULN); 2. Characteristic findings of acute pancreatitis on abdominal imaging; 2. A SpO2 \<96% with a FiO2 of 21% (room air) to 27%, or a SpO2 \<97% with a FiO2 ≥28%; 3. Diagnosis of SIRS, defined by the presence of at least 2 of the following 4 criteria: 1. Temperature \< 36°C or \> 38°C; 2. Heart rate \> 90 beats/minute; 3. Respiratory rate \>20 breaths/minute or arterial carbon dioxide tension (PaCO2) \<32 mmHg; 4. White blood cell count (WBC) \>12,000 mm3, or \<4,000 mm3, or \> 10% immature (band) forms; 4. No evidence of pancreatic necrosis on contrast-enhanced computed tomography (CECT performed in the 18 hours prior to consent or after consent and before Day 1; 5. Adults ≥ 18 years of age; 6. A female patient of child bearing potential who is sexually active with a male partner must be willing to practice acceptable methods of birth control for 365 days after the last dose of CM4620-IE; 7. A male patient who is sexually active with a female partner of childbearing potential must be willing to practice acceptable methods of birth control for 365 days after the last dose of CM4620-IE and must not donate sperm for 365 days. 8. Willing and able to, or have a legal authorized representative (LAR) that is willing and able to, provide informed consent to participate, and to cooperate with all aspects of the protocol.
Exclusion criteria
1. Any concurrent clinical condition that a study physician believes could potentially pose an unacceptable health risk to the patient while involved in the study, including a CV SOFA score of 4 at the time of screening, or may limit expected survival to \<6 months; 2. Suspected presence of cholangitis in the judgment of the treating investigator; 3. ERCP performed in the previous 7 days; 4. Any malignancy being treated with chemotherapy or immunotherapy; 5. Any autoimmune disease being treated with immunosuppressive medication or immunotherapy; 6. History of: 1. Acute pancreatitis with pancreatic necrosis on Contrast-Enhanced Computed Tomography (CECT) of the pancreas; 2. Chronic pancreatitis, pancreatic necrosis or necrosectomy, or pancreatic enzyme replacement therapy; 3. Biopsy proven cirrhosis, portal hypertension, hepatic failure/hepatic encephalopathy; 4. Known hepatitis B or C, or HIV; 5. History of organ or hematologic transplant; 6. Resuscitated cardiac arrest, myocardial infarction, revascularization, cardiovascular accident (CVA) in the 30 days prior to Day 1; 7. Current renal replacement therapy; 8. Current known abuse of cocaine or methamphetamine; 9. Known to be pregnant or are nursing; 10. Participated in another study of an investigational drug or therapeutic medical device in the 30 days prior to Day 1; 11. History of allergy to eggs or known hypersensitivity to any components of CM4620-IE.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Safety and Tolerability of CM4620-IE in Patients With Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (SIRS) or Hypoxemia. | 90 Days | Safety and tolerability will be assessed by monitoring the frequency, duration and severity of treatment-emergent adverse events (TEAEs) throughout the study period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Patients With a Change in Computed Tomography Severity Index (CTSI) Score Between Screening and Day 5 (or Discharge, if Earlier) | 5 days (or discharge, if earlier) | CTSI score measures abnormal pancreatic morphology and is the sum of two subscales. The Balthazar subscale rates pancreatic CT image findings on a scale of 0 (normal) to 4 (2 or more peri-pancreatic fluid collections. The Pancreatic Necrosis subscale rates pancreatic necrosis from 0 (none) to 6 (\>50%). The two subscales are summed for a CTSI score of 0-3 (mild AP), 4-6 (moderate AP), and 7-10 (severe AP). |
| The Number of Patients Tolerating Solid Food | at 72 hours (or discharge, if earlier) | Defined as eating ≥ 50% of a solid meal without vomiting or an increase in pain |
| Percentage of Patients With Persistent Systemic Inflammatory Response Syndrome (SIRS) | ≥ 48 hours | The presence of SIRS was defined as the presence of at least 2 of the following 4 criteria: * Temperature \< 36°C or \> 38°C; * Heart rate \> 90 beats/minute; * Respiratory rate \> 20 breaths/minute or arterial carbon dioxide tension (PaCO2) \< 32 mmHg; * White blood cell count (WBC) \> 12,000 cells/mm3 or \< 4,000 cells/mm3 or \> 10% immature (band) forms. * The SIRS score was determined at Screening, prior to randomization, and every 12 hours until Day 6, after which it was determined every 24 hours. |
| IL-6 Values in Patients With a Maximum IL-6 Value ≥ 150 pg/mL in the First 24 Hours | Day 10 (or discharge, if earlier) | Assess blood serum samples to be analyzed for interleuken (IL-6) llevels pg/mL collected in the first 24 hours and daily thereafter. Samples were sent to the central laboratory. The results were not provided to the Principal Investigator or treating physician. |
| Median Days in Hospital | discharge | Length of stay in hospital in days (randomization to discharge) |
Countries
United States
Contacts
STUDY_DIRECTORSudarshan Hebbar, MD
Chief Medical Officer
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Low Dose Group Consisted of 8 patients, 5 female and 3 male, who were randomized to receive CM4620-IE 1.0 mg/kg on Days 1 and 1.4 mg/kg on Days 2-4. All doses of CM4620-IE were administered intravenously (IV) over 4 hours. | 8 |
| High Dose Group Consisted of 6 male patients were randomized to receive CM4620-IE 2.08 mg/kg on Days 1 and 2, and 1.6 mg/kg on Days 3-4. All doses of CM4620-IE will be administered intravenously (IV) over 4 hours. | 6 |
| Standard of Care Group Consisted of 7 patients, 4 female and 3 male, who received local standard of care. | 7 |
| Total | 21 |
Baseline characteristics
| Characteristic | Total | Low Dose Group | High Dose Group | Standard of Care Group |
|---|---|---|---|---|
| Age, Continuous | 48.1 years STANDARD_DEVIATION 12.1 | 50.9 years STANDARD_DEVIATION 14.7 | 44.3 years STANDARD_DEVIATION 7.1 | 54.9 years STANDARD_DEVIATION 10.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 2 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 8 Participants | 4 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 14 Participants | 6 Participants | 4 Participants | 4 Participants |
| Region of Enrollment United States | 21 participants | 8 participants | 6 participants | 7 participants |
| Sex: Female, Male Female | 9 Participants | 5 Participants | 0 Participants | 4 Participants |
| Sex: Female, Male Male | 12 Participants | 3 Participants | 6 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 1 / 6 | 0 / 7 |
| other Total, other adverse events | 7 / 8 | 5 / 6 | 3 / 7 |
| serious Total, serious adverse events | 2 / 8 | 1 / 6 | 2 / 7 |
Outcome results
Primary
The Safety and Tolerability of CM4620-IE in Patients With Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (SIRS) or Hypoxemia.
Safety and tolerability will be assessed by monitoring the frequency, duration and severity of treatment-emergent adverse events (TEAEs) throughout the study period.
Time frame: 90 Days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Low Dose Group + SC | The Safety and Tolerability of CM4620-IE in Patients With Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (SIRS) or Hypoxemia. | Treatment-related TEAEs | 0 Participants |
| Low Dose Group + SC | The Safety and Tolerability of CM4620-IE in Patients With Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (SIRS) or Hypoxemia. | TEAE patients | 7 Participants |
| Low Dose Group + SC | The Safety and Tolerability of CM4620-IE in Patients With Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (SIRS) or Hypoxemia. | SAE patients | 2 Participants |
| Low Dose Group + SC | The Safety and Tolerability of CM4620-IE in Patients With Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (SIRS) or Hypoxemia. | TEAEs leading to death | 0 Participants |
| Low Dose Group + SC | The Safety and Tolerability of CM4620-IE in Patients With Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (SIRS) or Hypoxemia. | Severe TEAE patients | 0 Participants |
| Low Dose Group + SC | The Safety and Tolerability of CM4620-IE in Patients With Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (SIRS) or Hypoxemia. | TEAEs leading to discontinuation | 0 Participants |
| High Dose Group + SC | The Safety and Tolerability of CM4620-IE in Patients With Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (SIRS) or Hypoxemia. | Severe TEAE patients | 2 Participants |
| High Dose Group + SC | The Safety and Tolerability of CM4620-IE in Patients With Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (SIRS) or Hypoxemia. | TEAEs leading to death | 1 Participants |
| High Dose Group + SC | The Safety and Tolerability of CM4620-IE in Patients With Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (SIRS) or Hypoxemia. | Treatment-related TEAEs | 1 Participants |
| High Dose Group + SC | The Safety and Tolerability of CM4620-IE in Patients With Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (SIRS) or Hypoxemia. | TEAEs leading to discontinuation | 2 Participants |
| High Dose Group + SC | The Safety and Tolerability of CM4620-IE in Patients With Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (SIRS) or Hypoxemia. | SAE patients | 1 Participants |
| High Dose Group + SC | The Safety and Tolerability of CM4620-IE in Patients With Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (SIRS) or Hypoxemia. | TEAE patients | 5 Participants |
| Standard of Care Group (SC) | The Safety and Tolerability of CM4620-IE in Patients With Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (SIRS) or Hypoxemia. | Treatment-related TEAEs | 0 Participants |
| Standard of Care Group (SC) | The Safety and Tolerability of CM4620-IE in Patients With Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (SIRS) or Hypoxemia. | TEAE patients | 3 Participants |
| Standard of Care Group (SC) | The Safety and Tolerability of CM4620-IE in Patients With Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (SIRS) or Hypoxemia. | Severe TEAE patients | 2 Participants |
| Standard of Care Group (SC) | The Safety and Tolerability of CM4620-IE in Patients With Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (SIRS) or Hypoxemia. | SAE patients | 2 Participants |
| Standard of Care Group (SC) | The Safety and Tolerability of CM4620-IE in Patients With Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (SIRS) or Hypoxemia. | TEAEs leading to death | 0 Participants |
| Standard of Care Group (SC) | The Safety and Tolerability of CM4620-IE in Patients With Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (SIRS) or Hypoxemia. | TEAEs leading to discontinuation | 0 Participants |
Secondary
IL-6 Values in Patients With a Maximum IL-6 Value ≥ 150 pg/mL in the First 24 Hours
Assess blood serum samples to be analyzed for interleuken (IL-6) llevels pg/mL collected in the first 24 hours and daily thereafter. Samples were sent to the central laboratory. The results were not provided to the Principal Investigator or treating physician.
Time frame: Day 10 (or discharge, if earlier)
Population: Only patients with a maximum IL-6 value ≥ 150 pg/mL in the first 24 hours were analyzed. Further, since some patients IL-6 values decreased below 150 pg/mL, they are not displayed in the results table. Analysis only included patients who still had IL-6 values ≥ 150 pg/mL at Day 10 or discharge (whichever was earlier).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Low Dose Group + SC | IL-6 Values in Patients With a Maximum IL-6 Value ≥ 150 pg/mL in the First 24 Hours | Admission IL-6 Levels | IL-6 ≥ 1000 pg/mL | 0 Participants |
| Low Dose Group + SC | IL-6 Values in Patients With a Maximum IL-6 Value ≥ 150 pg/mL in the First 24 Hours | Admission IL-6 Levels | 150 pg/mL ≤ IL-6 < 1000 pg/mL | 4 Participants |
| Low Dose Group + SC | IL-6 Values in Patients With a Maximum IL-6 Value ≥ 150 pg/mL in the First 24 Hours | Day 10 or discharge IL-6 Levels | IL-6 ≥ 1000 pg/mL | 0 Participants |
| Low Dose Group + SC | IL-6 Values in Patients With a Maximum IL-6 Value ≥ 150 pg/mL in the First 24 Hours | Day 10 or discharge IL-6 Levels | 150 pg/mL ≤ IL-6 < 1000 pg/mL | 0 Participants |
| High Dose Group + SC | IL-6 Values in Patients With a Maximum IL-6 Value ≥ 150 pg/mL in the First 24 Hours | Day 10 or discharge IL-6 Levels | 150 pg/mL ≤ IL-6 < 1000 pg/mL | 1 Participants |
| High Dose Group + SC | IL-6 Values in Patients With a Maximum IL-6 Value ≥ 150 pg/mL in the First 24 Hours | Admission IL-6 Levels | IL-6 ≥ 1000 pg/mL | 2 Participants |
| High Dose Group + SC | IL-6 Values in Patients With a Maximum IL-6 Value ≥ 150 pg/mL in the First 24 Hours | Day 10 or discharge IL-6 Levels | IL-6 ≥ 1000 pg/mL | 0 Participants |
| High Dose Group + SC | IL-6 Values in Patients With a Maximum IL-6 Value ≥ 150 pg/mL in the First 24 Hours | Admission IL-6 Levels | 150 pg/mL ≤ IL-6 < 1000 pg/mL | 1 Participants |
| Standard of Care Group (SC) | IL-6 Values in Patients With a Maximum IL-6 Value ≥ 150 pg/mL in the First 24 Hours | Day 10 or discharge IL-6 Levels | 150 pg/mL ≤ IL-6 < 1000 pg/mL | 2 Participants |
| Standard of Care Group (SC) | IL-6 Values in Patients With a Maximum IL-6 Value ≥ 150 pg/mL in the First 24 Hours | Admission IL-6 Levels | 150 pg/mL ≤ IL-6 < 1000 pg/mL | 3 Participants |
| Standard of Care Group (SC) | IL-6 Values in Patients With a Maximum IL-6 Value ≥ 150 pg/mL in the First 24 Hours | Day 10 or discharge IL-6 Levels | IL-6 ≥ 1000 pg/mL | 0 Participants |
| Standard of Care Group (SC) | IL-6 Values in Patients With a Maximum IL-6 Value ≥ 150 pg/mL in the First 24 Hours | Admission IL-6 Levels | IL-6 ≥ 1000 pg/mL | 0 Participants |
Secondary
Median Days in Hospital
Length of stay in hospital in days (randomization to discharge)
Time frame: discharge
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Low Dose Group + SC | Median Days in Hospital | 3.06 days |
| High Dose Group + SC | Median Days in Hospital | 6.97 days |
| Standard of Care Group (SC) | Median Days in Hospital | 6.02 days |
Secondary
Percentage of Patients With Persistent Systemic Inflammatory Response Syndrome (SIRS)
The presence of SIRS was defined as the presence of at least 2 of the following 4 criteria: * Temperature \< 36°C or \> 38°C; * Heart rate \> 90 beats/minute; * Respiratory rate \> 20 breaths/minute or arterial carbon dioxide tension (PaCO2) \< 32 mmHg; * White blood cell count (WBC) \> 12,000 cells/mm3 or \< 4,000 cells/mm3 or \> 10% immature (band) forms. * The SIRS score was determined at Screening, prior to randomization, and every 12 hours until Day 6, after which it was determined every 24 hours.
Time frame: ≥ 48 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low Dose Group + SC | Percentage of Patients With Persistent Systemic Inflammatory Response Syndrome (SIRS) | 1 Participants |
| High Dose Group + SC | Percentage of Patients With Persistent Systemic Inflammatory Response Syndrome (SIRS) | 4 Participants |
| Standard of Care Group (SC) | Percentage of Patients With Persistent Systemic Inflammatory Response Syndrome (SIRS) | 5 Participants |
Secondary
The Number of Patients Tolerating Solid Food
Defined as eating ≥ 50% of a solid meal without vomiting or an increase in pain
Time frame: at Day 10 (or discharge, if earlier)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Low Dose Group + SC | The Number of Patients Tolerating Solid Food | 8 number of patients tolerating solid food |
| High Dose Group + SC | The Number of Patients Tolerating Solid Food | 5 number of patients tolerating solid food |
| Standard of Care Group (SC) | The Number of Patients Tolerating Solid Food | 3 number of patients tolerating solid food |
Secondary
The Number of Patients Tolerating Solid Food
Defined as eating ≥ 50% of a solid meal without vomiting or an increase in pain
Time frame: at 72 hours (or discharge, if earlier)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Low Dose Group + SC | The Number of Patients Tolerating Solid Food | 5 number of patients tolerating solid food |
| High Dose Group + SC | The Number of Patients Tolerating Solid Food | 2 number of patients tolerating solid food |
| Standard of Care Group (SC) | The Number of Patients Tolerating Solid Food | 1 number of patients tolerating solid food |
Secondary
The Number of Patients With a Change in Computed Tomography Severity Index (CTSI) Score Between Screening and Day 5 (or Discharge, if Earlier)
CTSI score measures abnormal pancreatic morphology and is the sum of two subscales. The Balthazar subscale rates pancreatic CT image findings on a scale of 0 (normal) to 4 (2 or more peri-pancreatic fluid collections. The Pancreatic Necrosis subscale rates pancreatic necrosis from 0 (none) to 6 (\>50%). The two subscales are summed for a CTSI score of 0-3 (mild AP), 4-6 (moderate AP), and 7-10 (severe AP).
Time frame: 5 days (or discharge, if earlier)
Population: One patient treated with the high dose regimen+SC did not receive a CTSI score at either the Screening or Day 5 or Discharge CECTs. One patient treated with SC alone did not receive a CTSI score at Screening because contrast was not given.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Low Dose Group + SC | The Number of Patients With a Change in Computed Tomography Severity Index (CTSI) Score Between Screening and Day 5 (or Discharge, if Earlier) | Day 5 or Discharge, if earlier | Number of Patients with Severe AP | 0 Participants |
| Low Dose Group + SC | The Number of Patients With a Change in Computed Tomography Severity Index (CTSI) Score Between Screening and Day 5 (or Discharge, if Earlier) | Screening | Number of Patients with Severe AP | 0 Participants |
| Low Dose Group + SC | The Number of Patients With a Change in Computed Tomography Severity Index (CTSI) Score Between Screening and Day 5 (or Discharge, if Earlier) | Day 5 or Discharge, if earlier | Number of Patients with Moderate AP | 1 Participants |
| Low Dose Group + SC | The Number of Patients With a Change in Computed Tomography Severity Index (CTSI) Score Between Screening and Day 5 (or Discharge, if Earlier) | Screening | Number of Patients with Mild AP | 4 Participants |
| Low Dose Group + SC | The Number of Patients With a Change in Computed Tomography Severity Index (CTSI) Score Between Screening and Day 5 (or Discharge, if Earlier) | Day 5 or Discharge, if earlier | Number of Patients with Mild AP | 7 Participants |
| Low Dose Group + SC | The Number of Patients With a Change in Computed Tomography Severity Index (CTSI) Score Between Screening and Day 5 (or Discharge, if Earlier) | Screening | Number of Patients with Moderate AP | 4 Participants |
| High Dose Group + SC | The Number of Patients With a Change in Computed Tomography Severity Index (CTSI) Score Between Screening and Day 5 (or Discharge, if Earlier) | Day 5 or Discharge, if earlier | Number of Patients with Mild AP | 1 Participants |
| High Dose Group + SC | The Number of Patients With a Change in Computed Tomography Severity Index (CTSI) Score Between Screening and Day 5 (or Discharge, if Earlier) | Day 5 or Discharge, if earlier | Number of Patients with Moderate AP | 4 Participants |
| High Dose Group + SC | The Number of Patients With a Change in Computed Tomography Severity Index (CTSI) Score Between Screening and Day 5 (or Discharge, if Earlier) | Day 5 or Discharge, if earlier | Number of Patients with Severe AP | 0 Participants |
| High Dose Group + SC | The Number of Patients With a Change in Computed Tomography Severity Index (CTSI) Score Between Screening and Day 5 (or Discharge, if Earlier) | Screening | Number of Patients with Moderate AP | 4 Participants |
| High Dose Group + SC | The Number of Patients With a Change in Computed Tomography Severity Index (CTSI) Score Between Screening and Day 5 (or Discharge, if Earlier) | Screening | Number of Patients with Severe AP | 0 Participants |
| High Dose Group + SC | The Number of Patients With a Change in Computed Tomography Severity Index (CTSI) Score Between Screening and Day 5 (or Discharge, if Earlier) | Screening | Number of Patients with Mild AP | 1 Participants |
| Standard of Care Group (SC) | The Number of Patients With a Change in Computed Tomography Severity Index (CTSI) Score Between Screening and Day 5 (or Discharge, if Earlier) | Day 5 or Discharge, if earlier | Number of Patients with Severe AP | 1 Participants |
| Standard of Care Group (SC) | The Number of Patients With a Change in Computed Tomography Severity Index (CTSI) Score Between Screening and Day 5 (or Discharge, if Earlier) | Screening | Number of Patients with Mild AP | 2 Participants |
| Standard of Care Group (SC) | The Number of Patients With a Change in Computed Tomography Severity Index (CTSI) Score Between Screening and Day 5 (or Discharge, if Earlier) | Screening | Number of Patients with Severe AP | 1 Participants |
| Standard of Care Group (SC) | The Number of Patients With a Change in Computed Tomography Severity Index (CTSI) Score Between Screening and Day 5 (or Discharge, if Earlier) | Day 5 or Discharge, if earlier | Number of Patients with Mild AP | 3 Participants |
| Standard of Care Group (SC) | The Number of Patients With a Change in Computed Tomography Severity Index (CTSI) Score Between Screening and Day 5 (or Discharge, if Earlier) | Day 5 or Discharge, if earlier | Number of Patients with Moderate AP | 3 Participants |
| Standard of Care Group (SC) | The Number of Patients With a Change in Computed Tomography Severity Index (CTSI) Score Between Screening and Day 5 (or Discharge, if Earlier) | Screening | Number of Patients with Moderate AP | 3 Participants |