FTIH Study of ECC0509 in Healthy Volunteers

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05012423
• Other study ID #: EC0001
• Status: Recruiting
• Phase: Phase 1
• Start date: July 7, 2021
• Est. completion date: February 20, 2022

Study information

• Verified date: August 2021
• Source: Eccogene (Shanghai) Co. Ltd
• Contact: Participant Engagement Manager
• Phone: 1800150433
• Email: cmax[@]cmax.com.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: February 20, 2022
• Est. primary completion date: February 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Key Inclusion Criteria:

1. Healthy male or non-childbearing potential female

2. Age =18 and =65 years old

3. BMI =18.0 and =32.0 kg/m2

4. Male participants agree to use contraception

5. No clinically significant abnormal findings in physical examination, 12-lead electrocardiogram (ECG), laboratory tests, or medical history

6. Able to understand and sign informed consent

Key Exclusion Criteria:

1. Significant allergic reactions to any drug.

2. History of significant drug abuse or alcohol abuse within 1 year prior to screening

3. Concomitant participation in any investigational study of any nature

4. Use of any concomitant medication except for the occasional use of acetaminophen (up to 2 g daily)

5. 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.

6. 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.

Related Conditions & MeSH terms

• Fatty Liver
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Steatohepatitis
• Osteoarthritis

Intervention

Drug:
• Placebo
Matching Placebo Placebo will be administered as oral capsules.
• ECC0509
ECC0509 1 mg and 10 mg capsules ECC0509 will be administered as oral capsules.
• Placebo
Matching Placebo Placebo will be given orally during each dosing day.
• ECC0509
ECC0509 1 mg and 10 mg capsules Placebo will be given orally during each dosing day.

Locations

Country	Name	City	State
Australia	CMAX Clinical Research	Adelaide	South Australia

Sponsors (2)

Lead Sponsor	Collaborator
Eccanga Pty Ltd	Syneos Health

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	SAD: Up to Day 8. MAD: Up to Day 21.
Primary	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.	SAD: Up to Day 8. MAD: Up to Day 21.
Primary	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.	SAD: Up to Day 8. MAD: Up to Day 21.
Primary	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.	SAD: Up to Day 8. MAD: Up to Day 21.
Primary	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.	SAD: Up to Day 8. MAD: Up to Day 21.
Primary	Number of subjects with abnormal values for electrocardiogram parameters	12-lead electrocardiogram will be obtained using an electrocardiogram machine.	SAD: Up to Day 8. MAD: Up to Day 21.
Primary	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.	SAD: Up to Day 8. MAD: Up to Day 21.
Primary	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.	SAD: Up to Day 8. MAD: Up to Day 21.
Primary	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	SAD: Up to Day 8. MAD: Up to Day 21.
Primary	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.	SAD: Up to Day 8. MAD: Up to Day 21.
Secondary	Pharmacokinetic assessment 1	Area under the plasma concentration versus time curve (AUC)	SAD: Up to Day 8. MAD: Up to Day 21.
Secondary	Pharmacokinetic assessment 2	Peak Plasma Concentration (Cmax)	SAD: Up to Day 8. MAD: Up to Day 21.
Secondary	Pharmacokinetic assessment 3	Time of peak plasma concentration (Tmax)	SAD: Up to Day 8. MAD: Up to Day 21.
Secondary	Pharmacokinetic assessment 4	Half life (T1/2)	SAD: Up to Day 8. MAD: Up to Day 21.
Secondary	Pharmacokinetic assessment 5	Apparent total clearance after oral administration (Cl/F)	SAD: Up to Day 8. MAD: Up to Day 21.
Secondary	Pharmacokinetic assessment 6	Apparent volume of distribution during terminal phase after oral administration (Vz/F)	SAD: Up to Day 8. MAD: Up to Day 21.
Secondary	Pharmacodynamic assessment	Plasma Semicarbazide-Sensitive Amine Oxidase (SSAO) Activity	SAD: Up to Day 8. MAD: Up to Day 21.