FTIH Study of ECC0509 in Healthy Volunteers

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

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 Overview

• Status: Completed
• Conditions: Osteoarthritis; Nonalcoholic Steatohepatitis
• Intervention / Treatment: Drug: Placebo; Drug: Placebo; Drug: ECC0509; Drug: ECC0509

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.

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • CMAX Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: MAD Cohorts 1 to 4: Participants receiving Placebo; Participants will be randomized to receive a once-daily dose of placebo for 14 days.	Drug: Placebo; Matching Placebo will be administered as oral capsules.; Drug: Placebo; Matching Placebo will be given orally during each dosing day.
Placebo Comparator: SAD Cohorts 1 to 6: Participants Receiving Placebo; Participants in each SAD cohort will be randomized to receive placebo.	Drug: Placebo; Matching Placebo will be administered as oral capsules.; Drug: Placebo; Matching Placebo will be given orally during each dosing day.
Experimental: SAD Cohorts 1 to 6: Participants receiving 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).	Drug: ECC0509; ECC0509 1 mg and 10 mg capsules. ECC0509 will be administered as oral capsules.; Drug: ECC0509; ECC0509 1 mg and 10 mg capsules
Experimental: MAD Cohorts 1 to 4: Participants receiving 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.	Drug: ECC0509; ECC0509 1 mg and 10 mg capsules. ECC0509 will be administered as oral capsules.; Drug: ECC0509; ECC0509 1 mg and 10 mg capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events, with abnormal laboratory test results, abnormal ECGs, abnormal vital signs, and abnormal physical examinations	Safety Assessment evaluated through adverse events, laboratory evaluations, vital signs, ECGs, and physical examination.	SAD: Up to Day 8. MAD: Up to Day 21.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ECC0509 PK parameters: Cl/F	Apparent clearance	SAD: Up to Day 8.
ECC0509 PK parameters: Vz/F	Apparent volume of distribution	SAD: Up to Day 8.
ECC0509 PK parameter: AUC0-24	Area under the concentration-time curve from time zero to time 24 hours	MAD: Up to Day 21
ECC0509 PK parameter: Cmax ss	Maximal observed concentration at steady-state	MAD: Up to Day 21
ECC0509 PK parameter: Tmax ss	Time when the maximal concentration is observed at steady-state	MAD: Up to Day 21
ECC0509 PK parameter: Tlag ss	Time prior to the first measurable (non-zero) concentration at steady-state	MAD: Up to Day 21
ECC0509 PK parameters: Cmax	Maximal observed concentration	SAD: Up to Day 8. MAD: Up to Day 21
ECC0509 PK parameter: Tmax	Time when the maximal concentration is observed	SAD: Up to Day 8. MAD: Up to Day 21
ECC0509 PK parameter: AUC0-t	Area under the curve up to the last quantifiable time-point	SAD: Up to Day 8. MAD: Up to Day 21
ECC0509 PK parameter: Cmin ss	Minimal observed concentration at steady-state	MAD: Up to Day 21
ECC0509 PK parameter: T½ el	Terminal elimination half-life	SAD: Up to Day 8. MAD: Up to Day 21
ECC0509 PK parameter: Kel	Terminal elimination rate constant	SAD: Up to Day 8. MAD: Up to Day 21
ECC0509 PK parameter: Clss/F	Apparent body clearance at steady-state	MAD: Up to Day 21
ECC0509 PK parameter: Vz ss/F	Apparent volume of distribution at steady-state	MAD: Up to Day 21
ECC0509 PK parameter: AUC0-τ	Area under the concentration-time curve for one dosing interval (τ) at steady state.	MAD: Up to Day 21
ECC0509 PK parameters: AUC0-inf	Area under the concentration-time curve from time zero to infinity	SAD: Up to Day 8. MAD: Up to Day 21
ECC0509 PK parameters: Residual area	Percentage of AUC0-inf due to extrapolation from the time of the last observed concentration to infinity	SAD: Up to Day 8. MAD: Up to Day 21
PD Parameter: SSAO	plasma semicarbazide-sensitive amine oxidase (SSAO) activity.	SAD: Up to Day 8. MAD: Up to Day 21.

Collaborators and Investigators

• Sponsor: Eccogene
• Collaborators: Syneos Health

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2021
• Primary Completion (Actual): July 22, 2023
• Study Completion (Actual): July 22, 2023

Study Registration Dates

• First Submitted: July 22, 2021
• First Submitted That Met QC Criteria: August 12, 2021
• First Posted (Actual): August 19, 2021

Study Record Updates

• Last Update Posted (Actual): September 25, 2024
• Last Update Submitted That Met QC Criteria: September 23, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: EC0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No