FTIH Study of ECC0509 in Healthy Volunteers
- Registration Number
- NCT05012423
- Lead Sponsor
- Eccanga Pty Ltd
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 86
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description SAD Cohorts 1 to 6: Participants Receiving Placebo Placebo Participants in each SAD cohort will be randomized to receive placebo. SAD Cohorts 1 to 6: Participants receiving ECC0509 ECC0509 Participants in each SAD cohort will be randomized to receive 1 of 6 escalating doses (1 mg, 4 mg, 10 mg, 20 mg, 40 mg, or 60 mg). MAD Cohorts 1 to 4: Participants receiving Placebo Placebo Participants will be randomized to receive a once-daily dose of placebo for 14 days. MAD Cohorts 1 to 4: Participants receiving ECC0509 ECC0509 Participants will be randomized to receive a once-daily dose of 1 of 4 escalating doses (3 mg, 10 mg, 30 mg, 60 mg) for 14 days.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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: AUC0-24 MAD: Up to Day 21 Area under the concentration-time curve from time zero to time 24 hours
ECC0509 PK parameter: Cmax ss MAD: Up to Day 21 Maximal observed concentration at steady-state
ECC0509 PK parameter: Tmax ss MAD: Up to Day 21 Time when the maximal concentration is observed at steady-state
ECC0509 PK parameter: Tlag ss MAD: Up to Day 21 Time prior to the first measurable (non-zero) concentration at steady-state
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: 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.
Trial Locations
- Locations (1)
CMAX Clinical Research
🇦🇺Adelaide, South Australia, Australia