FTIH Study of ECC0509 in Healthy Volunteers

Eccogene89 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Nonalcoholic Steatohepatitis Osteoarthritis

Interventions

PlaceboDRUG

Matching Placebo will be administered as oral capsules.

ECC0509DRUG

ECC0509 1 mg and 10 mg capsules. ECC0509 will be administered as oral capsules.

PlaceboDRUG

Matching Placebo will be given orally during each dosing day.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

CMAX Clinical Research

Adelaide, South Australia, Australia

Outcomes

Primary Outcomes

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.

Time frame: SAD: Up to Day 8. MAD: Up to Day 21.

Secondary Outcomes

ECC0509 PK parameters: Cl/F

Apparent clearance

Time frame: SAD: Up to Day 8.

ECC0509 PK parameters: Vz/F

Apparent volume of distribution

Time frame: SAD: Up to Day 8.

ECC0509 PK parameter: AUC0-24

Area under the concentration-time curve from time zero to time 24 hours

Time frame: MAD: Up to Day 21

ECC0509 PK parameter: Cmax ss

Maximal observed concentration at steady-state

Time frame: MAD: Up to Day 21

ECC0509 PK parameter: Tmax ss

Time when the maximal concentration is observed at steady-state

Time frame: MAD: Up to Day 21

ECC0509 PK parameter: Tlag ss

Time prior to the first measurable (non-zero) concentration at steady-state

Time frame: MAD: Up to Day 21

ECC0509 PK parameters: Cmax

Maximal observed concentration

Time frame: SAD: Up to Day 8. MAD: Up to Day 21

Data from ClinicalTrials.gov

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