Clinical Trials/NCT05552274

NCT05552274

Completed

Early Phase 1

A Randomized, Double-Blind, Placebo-Controlled, Single and Repeated Dose Escalation, FTIH Study to Investigate the Safety, Tolerability, PK and PD of ECC4703 in Healthy Volunteers and Participants With Treatment-Unnecessary LDL-C Under 160 mg/dL

Eccogene1 site in 1 country75 target enrollmentAugust 16, 2022

ConditionsNon-alcoholic Steatohepatitis (NASH)

InterventionsPlacebo ECC4703

DrugsECC4703 Placebo

Overview

Phase: Early Phase 1
Intervention: Placebo
Conditions: Non-alcoholic Steatohepatitis (NASH)
Sponsor: Eccogene
Enrollment: 75
Locations: 1
Primary Endpoint: Number of participants with adverse events, with abnormal laboratory test results, abnormal ECGs, abnormal vital signs, and abnormal physical examinations
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study of ECC4703 in healthy volunteers and participants with treatment unnecessary LDL-C under 160 mg/dL

Detailed Description

This study will be conducted in two cohorts of Single Ascending Dose (SAD) with a dose range from 1mg to 400mg and in four cohorts of Multiple Ascending Dose (MAD) with a dose range of 40mg to 160mg to Investigate the Safety, Tolerability, PK, and PD of ECC4703 in Healthy Volunteers and Participants with Treatment Unnecessary LDL-C under 160 mg/dL

Registry

clinicaltrials.gov

Start Date

August 16, 2022

End Date

October 26, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eccogene

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy male and female participants of any ethnic origin
•Age of 18 to 65 years
•BMI of 18.0 to 32.0 kg/m2
•Female participants who are postmenopausal, confirmed by FSH test, or surgically sterile, confirmed by medical documentation, or if they are of child bearing potential agree to use at least 1 highly effective method of contraception and 1 additional effective method at the same time, or agree to practice true abstinence
•Male participants agree to use contraception, or agree to practice true abstinence
•No clinically significant findings in physical examination, 12-lead electrocardiogram (ECG), vital sign measurements, laboratory tests, or medical/psychiatric history
•Not taking any medication on a regular basis
•Able to understand and sign and date informed consent
•Additional Inclusion Criteria for Part 2 (MAD) Cohorts B2 to B4
•Fasting LDL-C ≥ 100 mg/dL and ≤ 159 mg/dL at screening

Exclusion Criteria

•Females who are pregnant including a positive result of pregnancy test, planning to become pregnant, or breastfeeding.
•History of febrile illness or evidence of active infection within 14 days prior to the first dose of study;
•Use of any concomitant medication
•History of drug abuse or alcohol abuse within the past 5 years;
•Regular use of tobacco, nicotine or tobacco products within the past 6 months of the study ;
•Unwilling to abstain from alcohol containing products and/or xanthine/caffeine containing products, including any food and beverages, within 48 h prior to the first dose of study drug;
•Concomitant participation in any investigational study of any nature
•Blood loss of non-physiological reasons ≥ 200 ml (i.e. trauma, blood collection, blood donation) within 2 months prior to the first dose of study drug, or plan to donate blood during this trial and within 1 month after the last dosing;
•Abnormal renal function estimated glomerular filtration rate (eGFR) \< 90 mL/min/1.73m2
•Currently diagnosed type 2 diabetes mellitus (T2DM) or has history of T2DM.

Arms & Interventions

SAD Cohorts 1 to 2: Participants receiving Placebo

Participants in each SAD cohort will be randomized to receive placebo

Intervention: Placebo

SAD Cohorts 1 to 2: Participants receiving ECC4703

Participants in each SAD cohort will be randomized to receive up to 4 escalating doses (1 mg, 4 mg, 12 mg, 32 mg, 80 mg, 160 mg, 320 mg or 400 mg).

Intervention: ECC4703

MAD Cohorts 1 to 4: Participants receiving Placebo

Participants will be randomized to receive a once-daily dose of placebo for 14 days.

Intervention: Placebo

MAD Cohorts 1 to 4: Participants receiving ECC4703

Participants will be randomized to receive a once-daily dose of 1 of 3 escalating doses (40 mg, 80 mg, or 160 mg) for 14 days.

Intervention: ECC4703

Outcomes

Primary Outcomes

Number of participants with adverse events, with abnormal laboratory test results, abnormal ECGs, abnormal vital signs, and abnormal physical examinations

Time Frame: SAD: Up to 8 days and MAD: Up to 21 days

Safety Assessment evaluated through adverse events, laboratory evaluations, vital signs, ECGs, and physical examination.