FTIH of ECC4703 in Healthy Volunteers

NCT ID: NCT05552274

Last Updated: 2024-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-16
• Study Completion Date: 2023-10-26

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

Conditions

Non-alcoholic Steatohepatitis (NASH)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

SAD Cohorts 1 to 2: Participants receiving Placebo

Participants in each SAD cohort will be randomized to receive placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching Placebo will be administered as oral capsules. Matching Placebo will be given orally during each dosing day.

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).

Group Type: EXPERIMENTAL

ECC4703

Intervention Type: DRUG

ECC4703 will be administered as 1 mg, 10 mg and 40 mg capsules. ECC4703 will be administered as oral capsules during each dosing day.

MAD Cohorts 1 to 4: Participants receiving Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching Placebo will be administered as oral capsules. Matching Placebo will be given orally during each dosing day.

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.

Group Type: EXPERIMENTAL

ECC4703

Intervention Type: DRUG

ECC4703 will be administered as 1 mg, 10 mg and 40 mg capsules. ECC4703 will be administered as oral capsules during each dosing day.

Interventions

ECC4703

ECC4703 will be administered as 1 mg, 10 mg and 40 mg capsules. ECC4703 will be administered as oral capsules during each dosing day.

Intervention Type: DRUG

Placebo

Matching Placebo will be administered as oral capsules. Matching Placebo will be given orally during each dosing day.

Intervention Type: DRUG

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

• Fasting LDL-C ≥ 100 mg/dL and ≤ 159 mg/dL at screening
• Not eligible for lipid-lowering therapy (such as statin) as decided by the qualified clinician at screening based on <2019 ACC/AHA Guidelines on the Primary Prevention of Cardiovascular Disease>
• Hemoglobin A1c (HbA1c) ≤ 6.5%.

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.
• Significant allergic reaction to active ingredients or excipients of the study drug.
• Any clinically significant abnormal findings in the participant's physical examination, laboratory tests, pregnancy test, urine drug screen, alcohol test, or medical history which in the opinion of the Investigator would prevent the participants from participating in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eccogene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eccogene

Role: STUDY_DIRECTOR

Eccogene Clinical Trials

Locations

Eccogene Investigational Site

Las Vegas, Nevada, United States

Countries

United States

Other Identifiers

EC0002

Identifier Type: -

Identifier Source: org_study_id