Trial Outcomes & Findings for sPIF CLINICAL STUDY PROTOCOL IN AUTOIMMUNE HEPATITIS (NCT NCT02239562)

Last Updated: 2019-11-20

Results Overview

Single Ascending Dose (SAD): Adverse events, concomitant medications: Days 1, 2, 3, 5, 8 Vital signs, Physical exams: Days 1, 2, 8 Complete blood counts (CBC), Serum chemistry, Liver function tests, Pharmacokinetics: Days 1, 2, 8 Lipids, Coagulation, Urinalysis, Pregnancy test: Days 1, 8 EKG, chest x-ray (CXR): Days 1 and 8 Multiple Ascending Dose (MAD): Adverse events, concomitant medications: Days 1, 2, 3, 4, 5, 8, 15, 29 Vital signs, Physical exams: Days 1, 2, 3, 4, 5, 8, 15, 29 CBC, Serum chemistry, Liver function tests, Pharmacokinetics: Days 1, 3, 5, 8, 15, 29 Lipids, Coagulation, Urinalysis, Pregnancy test, EKG: Days 1, 5, 29 CXR: Days 1, 29

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

36 participants

Primary outcome timeframe

29 Day

Results posted on

2019-11-20

Participant Flow

sPIF (0.1, 0.5, or 1.0 mg/kg) given single SQ for 5 consecutive days. In SAD, n=18 randomized in a 2:1 sPIF/placebo ratio. 9 patients normal liver function and 9 abnormal liver function. In MAD, n=18 randomized in a 2:1 sPIF/placebo ratio. 9 patients normal liver function and 9 abnormal liver function. N=36 completed the study. total screened 36

Participant milestones

Participant milestones
Measure	SAD sPIF 0.1 single ascending dose (SAD) 3 patients with normal LFTs and 3 patients with abnormal LFTs randomized in a 2:1 ratio (active drug:placebo) as follows: Single SQ dose 0.1 mg/kg sPIF or Placebo Day 1	SAD sPIF 0.5 single ascending dose (SAD) 3 patients with normal LFTs and 3 patients with abnormal LFTs randomized in a 2:1 ratio (active drug:placebo) as follows: Single SQ dose 0.1 mg/kg sPIF or Placebo Day 1	SAD sPIF 1.0 single ascending dose (SAD) 3 patients with normal LFTs and 3 patients with abnormal LFTs randomized in a 2:1 ratio (active drug:placebo) as follows: Single SQ dose 0.1 mg/kg sPIF or Placebo Day 1	MAD sPIF 0.1 multiple ascending dose (MAD) 3 patients with normal LFTs and 3 patients with abnormal LFTs randomized in a 2:1 ratio (active drug:placebo) to multiple doses of sPIF SQ 1X day for 5 consecutive days (Days 1 to 5) Cohort 1: SQ 0.1 mg/kg sPIF or Placebo Days 1-5	MAD sPIF 0.5 multiple ascending dose (MAD) 3 patients with normal LFTs and 3 patients with abnormal LFTs randomized in a 2:1 ratio (active drug:placebo) to multiple doses of sPIF SQ 1X day for 5 consecutive days (Days 1 to 5) Cohort 1: SQ 0.1 mg/kg sPIF or Placebo Days 1-5	MAD sPIF 1.0 multiple ascending dose (MAD) 3 patients with normal LFTs and 3 patients with abnormal LFTs randomized in a 2:1 ratio (active drug:placebo) to multiple doses of sPIF SQ 1X day for 5 consecutive days (Days 1 to 5) Cohort 1: SQ 0.1 mg/kg sPIF or Placebo Days 1-5
Overall Study STARTED	6	6	6	6	6	6
Overall Study COMPLETED	6	6	6	6	6	6
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

sPIF CLINICAL STUDY PROTOCOL IN AUTOIMMUNE HEPATITIS

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SAD sPIF 0.1 n=6 Participants single ascending dose (SAD) 3 patients with normal LFTs and 3 patients with abnormal LFTs randomized in a 2:1 ratio (active drug:placebo) as follows: Single SQ dose 0.1 mg/kg sPIF or Placebo Day 1	SAD sPIF 0.5 n=6 Participants single ascending dose (SAD) 3 patients with normal LFTs and 3 patients with abnormal LFTs randomized in a 2:1 ratio (active drug:placebo) as follows: Single SQ dose 0.5 mg/kg sPIF or Placebo Day 1	SAD sPIF 1.0 n=6 Participants single ascending dose (SAD) 3 patients with normal LFTs and 3 patients with abnormal LFTs randomized in a 2:1 ratio (active drug:placebo) as follows: Single SQ dose 1.0 mg/kg sPIF or Placebo Day 1	MAD sPIF 0.1 n=6 Participants multiple ascending dose (MAD) 3 patients with normal LFTs and 3 patients with abnormal LFTs randomized in a 2:1 ratio (active drug : placebo) to multiple 0.1 mg/kg sPIF doses of sPIF administered subcutaneously once a day for 5 consecutive days (Days 1 to 5)	MAD sPIF 0.5 n=6 Participants multiple ascending dose (MAD) 3 patients with normal LFTs and 3 patients with abnormal LFTs randomized in a 2:1 ratio (active drug : placebo) to multiple 0.5 mg/kg sPIF doses of sPIF administered subcutaneously once a day for 5 consecutive days (Days 1 to 5)	MAD sPIF 1.0 n=6 Participants multiple ascending dose (MAD) 3 patients with normal LFTs and 3 patients with abnormal LFTs randomized in a 2:1 ratio (active drug : placebo) to multiple 1.0 mg/kg sPIF doses of sPIF administered subcutaneously once a day for 5 consecutive days (Days 1 to 5)	Total n=36 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	4 Participants n=21 Participants	5 Participants n=10 Participants	29 Participants n=115 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=10 Participants	7 Participants n=115 Participants
Age, Continuous	63 years STANDARD_DEVIATION 10 • n=5 Participants	59 years STANDARD_DEVIATION 8 • n=7 Participants	59 years STANDARD_DEVIATION 9 • n=5 Participants	56.75 years STANDARD_DEVIATION 13.40 • n=4 Participants	58.75 years STANDARD_DEVIATION 9.43 • n=21 Participants	58.5 years STANDARD_DEVIATION 7.33 • n=10 Participants	59.25 years STANDARD_DEVIATION 9.063 • n=115 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	6 Participants n=21 Participants	6 Participants n=10 Participants	36 Participants n=115 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Region of Enrollment United States	6 participants n=5 Participants	6 participants n=7 Participants	6 participants n=5 Participants	6 participants n=4 Participants	6 participants n=21 Participants	6 participants n=10 Participants	36 participants n=115 Participants

PRIMARY outcome

Timeframe: 29 Day

Population: All patients participating in each arm were assessed for adverse events by symptoms, physical examination and laboratory studies.

Outcome measures

Outcome measures
Measure	SAD sPIF 0.1 n=6 Participants single ascending dose (SAD) 3 patients with normal LFTs and 3 patients with abnormal LFTs randomized in a 2:1 ratio (active drug:placebo) as follows: Single SQ dose 0.1 mg/kg sPIF or Placebo Day 1	SAD sPIF 0.5 n=6 Participants single ascending dose (SAD) 3 patients with normal LFTs and 3 patients with abnormal LFTs randomized in a 2:1 ratio (active drug:placebo) as follows: Single SQ dose 0.5 mg/kg sPIF or Placebo Day 1	SAD sPIF 1.0 n=6 Participants single ascending dose (SAD) 3 patients with normal LFTs and 3 patients with abnormal LFTs randomized in a 2:1 ratio (active drug:placebo) as follows: Single SQ dose 1.0 mg/kg sPIF or Placebo Day 1	MAD sPIF 0.1 n=6 Participants multiple ascending dose (MAD) 3 patients with normal LFTs and 3 patients with abnormal LFTs randomized in a 2:1 ratio (active drug:placebo) to multiple doses of sPIF SQ 1X day for 5 consecutive days (Days 1 to 5) Cohort 1: SQ 0.1 mg/kg sPIF or Placebo Days 1-5	MAD sPIF 0.5 n=6 Participants multiple ascending dose (MAD) 3 patients with normal LFTs and 3 patients with abnormal LFTs randomized in a 2:1 ratio (active drug:placebo) to multiple doses of sPIF SQ 1X day for 5 consecutive days (Days 1 to 5) Cohort 1: SQ 0.5 mg/kg sPIF or Placebo Days 1-5	MAD sPIF 1.0 n=6 Participants multiple ascending dose (MAD) 3 patients with normal LFTs and 3 patients with abnormal LFTs randomized in a 2:1 ratio (active drug:placebo) to multiple doses of sPIF SQ 1X day for 5 consecutive days (Days 1 to 5) Cohort 1: SQ 1.0 mg/kg sPIF or Placebo Days 1-5
Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG PE Liver Grade 2,3,4 Adverse Events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG Muscular Grade 2,3,4 Adverse Events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG Cardiovascular Grade 2,3,4 Adverse Events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG Urinary Grade 2,3,4 Adverse Events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG Respiratory Grade 2,3,4 Adverse Events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG PE Respiratory Grade 2,3,4 Adverse Events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG Lab: Blood Grade 2,3,4 Adverse Events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG Lab: Digestive Grade 2,3,4 Adverse Events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG Lab: Respiratory Grade 2,3,4 Adverse Events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG Lab: Reproductive Grade 2,3,4 Adverse Events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG Liver Grade 2,3,4 Adverse Events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG Skeletal Grade 2,3,4 Adverse Events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG Nervous Grade 2,3,4 Adverse Events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG Endocrine Grade 2,3,4 Adverse Events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG Blood Grade 2,3,4 Adverse Events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG Skin Grade 2,3,4 Adverse Events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG Digestive Grade 2,3,4 Adverse Events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG Reproductive Grade 2,3,4 Adverse Events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG PE Skeletal Grade 2,3,4 Adverse Events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG PE Muscular Grade 2,3,4 Adverse Events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG PE Nervous Grade 2,3,4 Adverse Events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG PE Endocrine Grade 2,3,4 Adverse Events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG PE Cardiovascular Grade 2,3,4 Adverse Events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG PE Blood Grade 2,3,4 Adverse Events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG PE Skin Grade 2,3,4 Adverse Events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG PE Digestive Grade 2,3,4 Adverse Events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG PE Urinary Grade 2,3,4 Adverse Events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG PE Reproductive Grade 2,3, or 4 Adverse Events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG Lab: Liver Grade 2,3,4 Adverse Events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG Lab: Skeletal Grade 2,3,4 Adverse Events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG Lab: Muscular Grade 2,3,4 Adverse Events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG Lab: Nervous Grade 2,3,4 Adverse Events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG Lab: Endocrine Grade 2,3,4 Adverse Events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG Lab: Cardiovascular Grade 2,3,4 Adverse Events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG Lab: Skin Grade 2,3,4 Adverse Events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG Lab: Urinary Grade 2,3,4 Adverse Events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 29 Day

Following sPIF administration, using a validated assay, serum samples were tested for anti-sPIF antibodies

Outcome measures

Outcome measures
Measure	SAD sPIF 0.1 n=6 Participants single ascending dose (SAD) 3 patients with normal LFTs and 3 patients with abnormal LFTs randomized in a 2:1 ratio (active drug:placebo) as follows: Single SQ dose 0.1 mg/kg sPIF or Placebo Day 1	SAD sPIF 0.5 n=6 Participants single ascending dose (SAD) 3 patients with normal LFTs and 3 patients with abnormal LFTs randomized in a 2:1 ratio (active drug:placebo) as follows: Single SQ dose 0.5 mg/kg sPIF or Placebo Day 1	SAD sPIF 1.0 n=6 Participants single ascending dose (SAD) 3 patients with normal LFTs and 3 patients with abnormal LFTs randomized in a 2:1 ratio (active drug:placebo) as follows: Single SQ dose 1.0 mg/kg sPIF or Placebo Day 1	MAD sPIF 0.1 n=6 Participants multiple ascending dose (MAD) 3 patients with normal LFTs and 3 patients with abnormal LFTs randomized in a 2:1 ratio (active drug:placebo) to multiple doses of sPIF SQ 1X day for 5 consecutive days (Days 1 to 5) Cohort 1: SQ 0.1 mg/kg sPIF or Placebo Days 1-5	MAD sPIF 0.5 n=6 Participants multiple ascending dose (MAD) 3 patients with normal LFTs and 3 patients with abnormal LFTs randomized in a 2:1 ratio (active drug:placebo) to multiple doses of sPIF SQ 1X day for 5 consecutive days (Days 1 to 5) Cohort 1: SQ 0.5 mg/kg sPIF or Placebo Days 1-5	MAD sPIF 1.0 n=6 Participants multiple ascending dose (MAD) 3 patients with normal LFTs and 3 patients with abnormal LFTs randomized in a 2:1 ratio (active drug:placebo) to multiple doses of sPIF SQ 1X day for 5 consecutive days (Days 1 to 5) Cohort 1: SQ 1.0 mg/kg sPIF or Placebo Days 1-5
Number of Participants With Anti-sPIF Antibodies and Drug Interactions Number of Patients with anti-sPIF Antibody	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Anti-sPIF Antibodies and Drug Interactions Number of Patients with Drug to Drug Interactions	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Single Ascending Dose Placebo n=6 participants at risk Single dose of placebo administered subcutaneously (Day 1)	Single Ascending Dose 0.1 n=6 participants at risk Single dose 0.1 mg/kg sPIF administered subcutaneously (Day 1)	Single Ascending Dose 0.5 n=6 participants at risk Single dose 0.5 mg/kg sPIF administered subcutaneously (Day 1)	Single Ascending Dose 1.0 n=6 participants at risk Single dose 1.0 mg/kg sPIF administered subcutaneously (Day 1)	Multiple Ascending Placebo n=6 participants at risk Placebo administered subcutaneously once a day for 5 consecutive days (Days 1 to 5)	Multiple Ascending Dose 0.1 n=6 participants at risk 0.1 mg/kg sPIF administered subcutaneously once a day for 5 consecutive days (Days 1 to 5)	Multiple Ascending Dose 0.5 n=6 participants at risk 0.5 mg/kg sPIF administered subcutaneously once a day for 5 consecutive days (Days 1 to 5)	Multiple Ascending Dose 1.0 n=6 participants at risk 1.0 mg/kg sPIF administered subcutaneously once a day for 5 consecutive days (Days 1 to 5)
Gastrointestinal disorders liver fullness (bloating)	0.00% 0/6 • Adverse events were collected in the single ascending dose (SAD) until Day 8. Adverse events were collected in the multiple ascending dose (MAD) until Day 29. The total time period for the adverse event data collection was 26 months.	0.00% 0/6 • Adverse events were collected in the single ascending dose (SAD) until Day 8. Adverse events were collected in the multiple ascending dose (MAD) until Day 29. The total time period for the adverse event data collection was 26 months.	0.00% 0/6 • Adverse events were collected in the single ascending dose (SAD) until Day 8. Adverse events were collected in the multiple ascending dose (MAD) until Day 29. The total time period for the adverse event data collection was 26 months.	0.00% 0/6 • Adverse events were collected in the single ascending dose (SAD) until Day 8. Adverse events were collected in the multiple ascending dose (MAD) until Day 29. The total time period for the adverse event data collection was 26 months.	0.00% 0/6 • Adverse events were collected in the single ascending dose (SAD) until Day 8. Adverse events were collected in the multiple ascending dose (MAD) until Day 29. The total time period for the adverse event data collection was 26 months.	0.00% 0/6 • Adverse events were collected in the single ascending dose (SAD) until Day 8. Adverse events were collected in the multiple ascending dose (MAD) until Day 29. The total time period for the adverse event data collection was 26 months.	0.00% 0/6 • Adverse events were collected in the single ascending dose (SAD) until Day 8. Adverse events were collected in the multiple ascending dose (MAD) until Day 29. The total time period for the adverse event data collection was 26 months.	0.00% 0/6 • Adverse events were collected in the single ascending dose (SAD) until Day 8. Adverse events were collected in the multiple ascending dose (MAD) until Day 29. The total time period for the adverse event data collection was 26 months.
General disorders transient skin irritation	0.00% 0/6 • Adverse events were collected in the single ascending dose (SAD) until Day 8. Adverse events were collected in the multiple ascending dose (MAD) until Day 29. The total time period for the adverse event data collection was 26 months.	16.7% 1/6 • Number of events 1 • Adverse events were collected in the single ascending dose (SAD) until Day 8. Adverse events were collected in the multiple ascending dose (MAD) until Day 29. The total time period for the adverse event data collection was 26 months.	0.00% 0/6 • Adverse events were collected in the single ascending dose (SAD) until Day 8. Adverse events were collected in the multiple ascending dose (MAD) until Day 29. The total time period for the adverse event data collection was 26 months.	0.00% 0/6 • Adverse events were collected in the single ascending dose (SAD) until Day 8. Adverse events were collected in the multiple ascending dose (MAD) until Day 29. The total time period for the adverse event data collection was 26 months.	0.00% 0/6 • Adverse events were collected in the single ascending dose (SAD) until Day 8. Adverse events were collected in the multiple ascending dose (MAD) until Day 29. The total time period for the adverse event data collection was 26 months.	0.00% 0/6 • Adverse events were collected in the single ascending dose (SAD) until Day 8. Adverse events were collected in the multiple ascending dose (MAD) until Day 29. The total time period for the adverse event data collection was 26 months.	0.00% 0/6 • Adverse events were collected in the single ascending dose (SAD) until Day 8. Adverse events were collected in the multiple ascending dose (MAD) until Day 29. The total time period for the adverse event data collection was 26 months.	0.00% 0/6 • Adverse events were collected in the single ascending dose (SAD) until Day 8. Adverse events were collected in the multiple ascending dose (MAD) until Day 29. The total time period for the adverse event data collection was 26 months.
Nervous system disorders headache	0.00% 0/6 • Adverse events were collected in the single ascending dose (SAD) until Day 8. Adverse events were collected in the multiple ascending dose (MAD) until Day 29. The total time period for the adverse event data collection was 26 months.	16.7% 1/6 • Number of events 1 • Adverse events were collected in the single ascending dose (SAD) until Day 8. Adverse events were collected in the multiple ascending dose (MAD) until Day 29. The total time period for the adverse event data collection was 26 months.	0.00% 0/6 • Adverse events were collected in the single ascending dose (SAD) until Day 8. Adverse events were collected in the multiple ascending dose (MAD) until Day 29. The total time period for the adverse event data collection was 26 months.	0.00% 0/6 • Adverse events were collected in the single ascending dose (SAD) until Day 8. Adverse events were collected in the multiple ascending dose (MAD) until Day 29. The total time period for the adverse event data collection was 26 months.	0.00% 0/6 • Adverse events were collected in the single ascending dose (SAD) until Day 8. Adverse events were collected in the multiple ascending dose (MAD) until Day 29. The total time period for the adverse event data collection was 26 months.	0.00% 0/6 • Adverse events were collected in the single ascending dose (SAD) until Day 8. Adverse events were collected in the multiple ascending dose (MAD) until Day 29. The total time period for the adverse event data collection was 26 months.	0.00% 0/6 • Adverse events were collected in the single ascending dose (SAD) until Day 8. Adverse events were collected in the multiple ascending dose (MAD) until Day 29. The total time period for the adverse event data collection was 26 months.	0.00% 0/6 • Adverse events were collected in the single ascending dose (SAD) until Day 8. Adverse events were collected in the multiple ascending dose (MAD) until Day 29. The total time period for the adverse event data collection was 26 months.

Additional Information

Christopher O'Brien

University of Miami

Phone: 305-243-2329

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60