FTIH of ECC4703 in Healthy Volunteers

Sponsor

Eccogene (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05552274

Collaborator

(none)

Enrollment

Location

Arms

10.6

Anticipated Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Non-alcoholic Steatohepatitis (NASH)	Drug: ECC4703 Drug: Placebo	Early Phase 1

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

Double-blind

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 16, 2022

Anticipated Primary Completion Date :

Jul 5, 2023

Anticipated Study Completion Date :

Jul 5, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: SAD Cohorts 1 to 2: Participants receiving Placebo Participants in each SAD cohort will be randomized to receive placebo	Drug: Placebo Matching Placebo will be administered as oral capsules. Matching Placebo will be given orally during each dosing day.
Experimental: 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).	Drug: 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.
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. Matching Placebo will be given orally during each dosing day.
Experimental: 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.	Drug: 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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Pharmacokinetic Parameters: AUC0-24 [SAD: Up to Day 8 and MAD: Up to Day 21.]
AUC from time 0 to 24 hour dosing interval
Pharmacokinetic Parameters: AUC0-tlast [SAD: Up to Day 8]
AUC from time 0 to the time of last quantifiable non-zero concentration
Pharmacokinetic Parameters: AUC0-tau [MAD: Up to Day 21.]
AUC over a dosing interval from time 0 to time of last quantifiable concentration
Pharmacokinetic Parameters: AUC0-infinity [SAD: Up to Day 8]
AUC from time 0 extrapolated to infinity
Pharmacokinetic Parameters: Cmax [SAD: Up to Day 8 and MAD: Up to Day 21.]
Maximum observed plasma concentration
Pharmacokinetic Parameters: C24 [SAD: Up to Day 8 and MAD: Up to Day 21.]
Observed concentration at 24 hours post dose
Pharmacokinetic Parameters: Ctau [MAD: Up to Day 21.]
Observed concentration at the end of the dosing interval
Pharmacokinetic Parameters: tmax [SAD: Up to Day 8 and MAD: Up to Day 21.]
Time of the maximum observed plasma concentration
Pharmacokinetic Parameters: tlag [SAD: Up to Day 8 and MAD: Up to Day 21.]
Lag time (time delay between dosing and first observed plasma concentration)
Pharmacokinetic Parameters: t1/2 [SAD: Up to Day 8 and MAD: Up to Day 21.]
Apparent terminal elimination half-life
Pharmacokinetic Parameters: Clast [SAD: Up to Day 8]
Last measurable non-zero concentration
Pharmacokinetic Parameters: tlast [SAD: Up to Day 8]
Time of last measurable non-zero concentration
Pharmacokinetic Parameters: CL/F [SAD: Up to Day 8 and MAD: Up to Day 21.]
Apparent Clearance
Pharmacodynamic assessment: LDL-C [SAD: Up to Day 8]
Measurement of Low Density Lipoprotein Cholesterol
Pharmacodynamic assessment: HDL-C [MAD: Up to Day 21.]
Measurement of High Density Lipoprotein Cholesterol
Pharmacodynamic assessment: TG [MAD: Up to Day 21.]
Measurement of Triglycerides
Pharmacodynamic assessment: TC [MAD: Up to Day 21.]
Measurement of Total Cholesterol
Pharmacodynamic assessment: LDL [MAD: Up to Day 21.]
Measurement of Low Density Lipoprotein
Pharmacodynamic assessment: VLDL [MAD: Up to Day 21.]
Measurement of Very Low Density Lipoprotein
Pharmacodynamic assessment: ApoB [SAD: Up to Day 8 and MAD: Up to Day 21.]
Measurement of Apolipoprotein B
Pharmacodynamic assessment: Lp(a) [MAD: Up to Day 21.]
Measurement of Lipoprotein (a)
Pharmacodynamic assessment: Glucose [MAD: Up to Day 21.]
Measurement of Glucose
Pharmacodynamic assessment: Serum Insulin [MAD: Up to Day 21.]
Measurement of Serum Insulin
Thyroid function assessment: TT3 [SAD: Up to Day 8 and MAD: Up to Day 21.]
Measurement of Total Triiodothyronine
Thyroid function assessment: FT3 [SAD: Up to Day 8 and MAD: Up to Day 21.]
Measurement of Free Triiodothyronine
Thyroid function assessment: TT4 [SAD: Up to Day 8 and MAD: Up to Day 21.]
Measurement of Total Thyroxine
Thyroid function assessment: FT4 [SAD: Up to Day 8 and MAD: Up to Day 21.]
Measurement of Free Thyroxine
Thyroid function assessment: TSH [SAD: Up to Day 8 and MAD: Up to Day 21.]
Measurement of Thyroid Stimulating Hormone

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eccogene Investigational Site	Las Vegas	Nevada	United States	89113

Sponsors and Collaborators

Eccogene

Investigators

Study Director: Eccogene, Eccogene Clinical Trials

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eccogene

ClinicalTrials.gov Identifier:

NCT05552274

Other Study ID Numbers:

EC0002

First Posted:

Sep 23, 2022

Last Update Posted:

Sep 23, 2022

Last Verified:

Sep 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Fatty Liver

Non-alcoholic Fatty Liver Disease

Study Results

No Results Posted as of Sep 23, 2022