Back to resultsFTIH Study of ECC0509 in Healthy Volunteers
Primary Purpose
Nonalcoholic Steatohepatitis, Osteoarthritis
Status
Unknown status
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
Placebo
ECC0509
Placebo
ECC0509
Sponsored by
About this trial
This is an interventional treatment trial for Nonalcoholic Steatohepatitis
Eligibility Criteria
Key Inclusion Criteria:
- Healthy male or non-childbearing potential female
- Age ≥18 and ≤65 years old
- BMI ≥18.0 and ≤32.0 kg/m2
- Male participants agree to use contraception
- No clinically significant abnormal findings in physical examination, 12-lead electrocardiogram (ECG), laboratory tests, or medical history
- Able to understand and sign informed consent
Key Exclusion Criteria:
- Significant allergic reactions to any drug.
- History of significant drug abuse or alcohol abuse within 1 year prior to screening
- Concomitant participation in any investigational study of any nature
- Use of any concomitant medication except for the occasional use of acetaminophen (up to 2 g daily)
- Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or more of whole blood within 8 weeks prior to dosing.
- Any clinically significant abnormal findings in the participant's physical examination, laboratory tests, pregnancy test, urine drug screen, alcohol breath test, or medical history which, in the opinion of the Investigator, would prevent the subject from participating in the study.
Sites / Locations
- CMAX Clinical ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Arm Label
SAD Cohorts 1 to 7: Participants Receiving Placebo
SAD Cohorts 1 to 7: Participants receiving ECC0509
MAD Cohorts 1 to 3: Participants receiving Placebo
MAD Cohorts 1 to 3: Participants receiving ECC0509
Arm Description
Participants in each SAD cohort will be randomized to receive placebo.
Participants in each SAD cohort will be randomized to receive 1 of 7 escalating doses (1 mg, 4 mg, 10 mg, 20 mg, 40 mg, 60 mg, or 80 mg).
Participants will be randomized to receive a once-daily dose of placebo for 14 days.
Participants will be randomized to receive a once-daily dose of 1 of 3 escalating doses (8 mg, 20 mg, or 40 mg) for 14 days.
Outcomes
Primary Outcome Measures
Number of subjects with adverse events and serious adverse events
An adverse event is any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Serious adverse event is defined as any untoward medical occurrence that, at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or other situations as per medical or scientific judgment.
Number of subjects with abnormal values for blood pressure
Systolic and diastolic blood pressure of subjects will be measured in a semi-supine position after at least 5 minutes of rest.
Number of subjects with abnormal values for pulse rate
Pulse rate of subjects will be measured in a semi-supine or supine position after at least 5 minutes of rest.
Number of subjects with abnormal values for respiratory rate
Respiratory rate of subjects will be measured in a semi-supine position after at least 5 minutes of rest.
Number of subjects with abnormal values for tympanic temperature
Tympanic temperature of subjects will be measured in a semi-supine position after at least 5 minutes of rest.
Number of subjects with abnormal values for electrocardiogram parameters
12-lead electrocardiogram will be obtained using an electrocardiogram machine.
Number of subjects with abnormal findings for clinical chemistry parameters
Blood samples will be collected from subjects for analysis of clinical chemistry parameters including urea, potassium, AST, total bilirubin, direct bilirubin, creatinine sodium bicarbonate, chloride, ALT, albumin, glucose, calcium, phosphate, alkaline phosphatase, cholesterol.
Number of subjects with abnormal findings for hematology parameters
Blood samples will be collected from subjects for analysis of hematology parameters including platelet count, mean platelet volume, mean cell volume, mean cell hemoglobin, mean corpuscular hemoglobin concentration, white blood cells count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, red blood cells count, hemoglobin and hematocrit.
Number of subjects with abnormal findings for coagulation parameters
Blood samples will be collected from subjects for analysis of coagulation parameters including Activated Thromboplastin Time, Prothrombin Time and International Normalized Ratio
Number of subjects with abnormal findings for urinalysis parameters
Urine samples will be collected from subjects for analysis of specific gravity, potential of hydrogen (pH) of urine, presence of glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, and leukocyte esterase in urine by dipstick test. Microscopic examination will be performed if blood or protein is abnormal.
Secondary Outcome Measures
Pharmacokinetic assessment 1
Area under the plasma concentration versus time curve (AUC)
Pharmacokinetic assessment 2
Peak Plasma Concentration (Cmax)
Pharmacokinetic assessment 3
Time of peak plasma concentration (Tmax)
Pharmacokinetic assessment 4
Half life (T1/2)
Pharmacokinetic assessment 5
Apparent total clearance after oral administration (Cl/F)
Pharmacokinetic assessment 6
Apparent volume of distribution during terminal phase after oral administration (Vz/F)
Pharmacodynamic assessment
Plasma Semicarbazide-Sensitive Amine Oxidase (SSAO) Activity
Full Information
NCT ID
NCT05012423
First Posted
July 22, 2021
Last Updated
August 12, 2021
Sponsor
Eccanga Pty Ltd
Collaborators
Syneos Health
1. Study Identification
Unique Protocol Identification Number
NCT05012423
Brief Title
FTIH Study of ECC0509 in Healthy Volunteers
Official Title
A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single And Multiple Ascending Dose, First-Time-In-Human Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Ecc0509 In Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 7, 2021 (Actual)
Primary Completion Date
February 20, 2022 (Anticipated)
Study Completion Date
February 20, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eccanga Pty Ltd
Collaborators
Syneos Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single And Multiple Ascending Dose, First-Time-In-Human Study to Assess The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ECC0509 in Healthy Volunteers.
Detailed Description
This study will be conducted in up to seven cohorts of Single Ascending Dose (SAD) & 3 cohorts of Multiple Ascending Dose (MAD). SAD will consist of a staggered dosing approach with a dose range from 1mg to 80mg. Staggered dosing approach will not be deployed for MAD cohorts with a dose range of 8mg to 40mg. In the MAD cohort, the effect of food will also be assessed by comparing the PK profile of Day 10 fed conditions against Day 14 fasted conditions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Steatohepatitis, Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
86 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SAD Cohorts 1 to 7: Participants Receiving Placebo
Arm Type
Placebo Comparator
Arm Description
Participants in each SAD cohort will be randomized to receive placebo.
Arm Title
SAD Cohorts 1 to 7: Participants receiving ECC0509
Arm Type
Experimental
Arm Description
Participants in each SAD cohort will be randomized to receive 1 of 7 escalating doses (1 mg, 4 mg, 10 mg, 20 mg, 40 mg, 60 mg, or 80 mg).
Arm Title
MAD Cohorts 1 to 3: Participants receiving Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will be randomized to receive a once-daily dose of placebo for 14 days.
Arm Title
MAD Cohorts 1 to 3: Participants receiving ECC0509
Arm Type
Experimental
Arm Description
Participants will be randomized to receive a once-daily dose of 1 of 3 escalating doses (8 mg, 20 mg, or 40 mg) for 14 days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching Placebo
Placebo will be administered as oral capsules.
Intervention Type
Drug
Intervention Name(s)
ECC0509
Intervention Description
ECC0509 1 mg and 10 mg capsules
ECC0509 will be administered as oral capsules.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching Placebo
Placebo will be given orally during each dosing day.
Intervention Type
Drug
Intervention Name(s)
ECC0509
Intervention Description
ECC0509 1 mg and 10 mg capsules
Placebo will be given orally during each dosing day.
Primary Outcome Measure Information:
Title
Number of subjects with adverse events and serious adverse events
Description
An adverse event is any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Serious adverse event is defined as any untoward medical occurrence that, at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or other situations as per medical or scientific judgment.
Time Frame
SAD: Up to Day 8. MAD: Up to Day 21.
Title
Number of subjects with abnormal values for blood pressure
Description
Systolic and diastolic blood pressure of subjects will be measured in a semi-supine position after at least 5 minutes of rest.
Time Frame
SAD: Up to Day 8. MAD: Up to Day 21.
Title
Number of subjects with abnormal values for pulse rate
Description
Pulse rate of subjects will be measured in a semi-supine or supine position after at least 5 minutes of rest.
Time Frame
SAD: Up to Day 8. MAD: Up to Day 21.
Title
Number of subjects with abnormal values for respiratory rate
Description
Respiratory rate of subjects will be measured in a semi-supine position after at least 5 minutes of rest.
Time Frame
SAD: Up to Day 8. MAD: Up to Day 21.
Title
Number of subjects with abnormal values for tympanic temperature
Description
Tympanic temperature of subjects will be measured in a semi-supine position after at least 5 minutes of rest.
Time Frame
SAD: Up to Day 8. MAD: Up to Day 21.
Title
Number of subjects with abnormal values for electrocardiogram parameters
Description
12-lead electrocardiogram will be obtained using an electrocardiogram machine.
Time Frame
SAD: Up to Day 8. MAD: Up to Day 21.
Title
Number of subjects with abnormal findings for clinical chemistry parameters
Description
Blood samples will be collected from subjects for analysis of clinical chemistry parameters including urea, potassium, AST, total bilirubin, direct bilirubin, creatinine sodium bicarbonate, chloride, ALT, albumin, glucose, calcium, phosphate, alkaline phosphatase, cholesterol.
Time Frame
SAD: Up to Day 8. MAD: Up to Day 21.
Title
Number of subjects with abnormal findings for hematology parameters
Description
Blood samples will be collected from subjects for analysis of hematology parameters including platelet count, mean platelet volume, mean cell volume, mean cell hemoglobin, mean corpuscular hemoglobin concentration, white blood cells count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, red blood cells count, hemoglobin and hematocrit.
Time Frame
SAD: Up to Day 8. MAD: Up to Day 21.
Title
Number of subjects with abnormal findings for coagulation parameters
Description
Blood samples will be collected from subjects for analysis of coagulation parameters including Activated Thromboplastin Time, Prothrombin Time and International Normalized Ratio
Time Frame
SAD: Up to Day 8. MAD: Up to Day 21.
Title
Number of subjects with abnormal findings for urinalysis parameters
Description
Urine samples will be collected from subjects for analysis of specific gravity, potential of hydrogen (pH) of urine, presence of glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, and leukocyte esterase in urine by dipstick test. Microscopic examination will be performed if blood or protein is abnormal.
Time Frame
SAD: Up to Day 8. MAD: Up to Day 21.
Secondary Outcome Measure Information:
Title
Pharmacokinetic assessment 1
Description
Area under the plasma concentration versus time curve (AUC)
Time Frame
SAD: Up to Day 8. MAD: Up to Day 21.
Title
Pharmacokinetic assessment 2
Description
Peak Plasma Concentration (Cmax)
Time Frame
SAD: Up to Day 8. MAD: Up to Day 21.
Title
Pharmacokinetic assessment 3
Description
Time of peak plasma concentration (Tmax)
Time Frame
SAD: Up to Day 8. MAD: Up to Day 21.
Title
Pharmacokinetic assessment 4
Description
Half life (T1/2)
Time Frame
SAD: Up to Day 8. MAD: Up to Day 21.
Title
Pharmacokinetic assessment 5
Description
Apparent total clearance after oral administration (Cl/F)
Time Frame
SAD: Up to Day 8. MAD: Up to Day 21.
Title
Pharmacokinetic assessment 6
Description
Apparent volume of distribution during terminal phase after oral administration (Vz/F)
Time Frame
SAD: Up to Day 8. MAD: Up to Day 21.
Title
Pharmacodynamic assessment
Description
Plasma Semicarbazide-Sensitive Amine Oxidase (SSAO) Activity
Time Frame
SAD: Up to Day 8. MAD: Up to Day 21.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Key Inclusion Criteria:
Healthy male or non-childbearing potential female
Age ≥18 and ≤65 years old
BMI ≥18.0 and ≤32.0 kg/m2
Male participants agree to use contraception
No clinically significant abnormal findings in physical examination, 12-lead electrocardiogram (ECG), laboratory tests, or medical history
Able to understand and sign informed consent
Key Exclusion Criteria:
Significant allergic reactions to any drug.
History of significant drug abuse or alcohol abuse within 1 year prior to screening
Concomitant participation in any investigational study of any nature
Use of any concomitant medication except for the occasional use of acetaminophen (up to 2 g daily)
Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or more of whole blood within 8 weeks prior to dosing.
Any clinically significant abnormal findings in the participant's physical examination, laboratory tests, pregnancy test, urine drug screen, alcohol breath test, or medical history which, in the opinion of the Investigator, would prevent the subject from participating in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Participant Engagement Manager
Phone
1800150433
Email
cmax@cmax.com.au
Facility Information:
Facility Name
CMAX Clinical Research
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Participant Engagement Manager
Phone
1800150433
Email
cmax@cmax.com.au
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
FTIH Study of ECC0509 in Healthy Volunteers
We'll reach out to this number within 24 hrs