FTIH of ECC4703 in Healthy Volunteers

NCT05552274 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: EC0002
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Conditions

Non-alcoholic Steatohepatitis (NASH)

Outcome Measures

Primary Outcomes (1)

• 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 8 days and MAD: Up to 21 days

Secondary Outcomes (28)

• Pharmacokinetic Parameters: AUC0-24

  SAD: Up to Day 8 and MAD: Up to Day 21.

• Pharmacokinetic Parameters: AUC0-tlast

  SAD: Up to Day 8

• Pharmacokinetic Parameters: AUC0-tau

  MAD: Up to Day 21.

• Pharmacokinetic Parameters: AUC0-infinity

  SAD: Up to Day 8

• Pharmacokinetic Parameters: Cmax

  SAD: Up to Day 8 and MAD: Up to Day 21.

Study Arms (4)

SAD Cohorts 1 to 2: Participants receiving Placebo

PLACEBO COMPARATOR

Participants in each SAD cohort will be randomized to receive placebo

Drug: Placebo

SAD Cohorts 1 to 2: Participants receiving ECC4703

EXPERIMENTAL

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).

Drug: ECC4703

MAD Cohorts 1 to 4: Participants receiving Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

MAD Cohorts 1 to 4: Participants receiving ECC4703

EXPERIMENTAL

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.

Drug: ECC4703

Interventions

ECC4703 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 ECC4703; SAD Cohorts 1 to 2: Participants receiving ECC4703

Placebo 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 Placebo; SAD Cohorts 1 to 2: Participants receiving Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eccogene: lead

Study Sites (1)

Eccogene Investigational Site

Las Vegas, Nevada, 89113, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Eccogene

  Eccogene Clinical Trials

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 23, 2022
• Study Start: August 16, 2022
• Primary Completion: October 26, 2023
• Study Completion: October 26, 2023
• Last Updated: July 5, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)