Nonalcoholic Steatohepatitis, Osteoarthritis
Conditions
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.
Interventions
DRUGPlacebo
Matching Placebo will be administered as oral capsules.
DRUGECC0509
ECC0509 1 mg and 10 mg capsules. ECC0509 will be administered as oral capsules.
Sponsors
Eccogene
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events, with abnormal laboratory test results, abnormal ECGs, abnormal vital signs, and abnormal physical examinations | SAD: Up to Day 8. MAD: Up to Day 21. | Safety Assessment evaluated through adverse events, laboratory evaluations, vital signs, ECGs, and physical examination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ECC0509 PK parameters: Cmax | SAD: Up to Day 8. MAD: Up to Day 21 | Maximal observed concentration |
| ECC0509 PK parameter: Tmax | SAD: Up to Day 8. MAD: Up to Day 21 | Time when the maximal concentration is observed |
| ECC0509 PK parameter: AUC0-t | SAD: Up to Day 8. MAD: Up to Day 21 | Area under the curve up to the last quantifiable time-point |
| ECC0509 PK parameter: Cmin ss | MAD: Up to Day 21 | Minimal observed concentration at steady-state |
| ECC0509 PK parameter: T½ el | SAD: Up to Day 8. MAD: Up to Day 21 | Terminal elimination half-life |
| ECC0509 PK parameter: Tmax ss | MAD: Up to Day 21 | Time when the maximal concentration is observed at steady-state |
| ECC0509 PK parameters: Cl/F | SAD: Up to Day 8. | Apparent clearance |
| ECC0509 PK parameters: Vz/F | SAD: Up to Day 8. | Apparent volume of distribution |
| ECC0509 PK parameter: Tlag ss | MAD: Up to Day 21 | Time prior to the first measurable (non-zero) concentration at steady-state |
| ECC0509 PK parameter: Cmax ss | MAD: Up to Day 21 | Maximal observed concentration at steady-state |
| ECC0509 PK parameter: Kel | SAD: Up to Day 8. MAD: Up to Day 21 | Terminal elimination rate constant |
| ECC0509 PK parameter: Clss/F | MAD: Up to Day 21 | Apparent body clearance at steady-state |
| ECC0509 PK parameter: Vz ss/F | MAD: Up to Day 21 | Apparent volume of distribution at steady-state |
| ECC0509 PK parameter: AUC0-τ | MAD: Up to Day 21 | Area under the concentration-time curve for one dosing interval (τ) at steady state. |
| ECC0509 PK parameters: AUC0-inf | SAD: Up to Day 8. MAD: Up to Day 21 | Area under the concentration-time curve from time zero to infinity |
| ECC0509 PK parameters: Residual area | SAD: Up to Day 8. MAD: Up to Day 21 | Percentage of AUC0-inf due to extrapolation from the time of the last observed concentration to infinity |
| PD Parameter: SSAO | SAD: Up to Day 8. MAD: Up to Day 21. | plasma semicarbazide-sensitive amine oxidase (SSAO) activity. |
| ECC0509 PK parameter: AUC0-24 | MAD: Up to Day 21 | Area under the concentration-time curve from time zero to time 24 hours |
Countries
Australia
Outcome results
None listed