FTIH of ECC5004 in Healthy and Diabetic Participants

July 15, 2024 updated by: Eccogene

A Randomized, Double-Blind, Placebo-Controlled, Single and Repeated Dose Escalation, First-Time-In-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ECC5004 in Healthy Participants and in Patients With Type 2 Diabetes Mellitus

This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study of ECC5004 in healthy participants and in patients with Type 2 Diabetes Mellitus

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will be conducted in two cohorts of Single Ascending Dose (SAD) with a dose range from 1mg to 300mg, and in four cohorts of Multiple Ascending Dose (MAD) with a dose range of 10mg to 150mg to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ECC5004 in Healthy Participants and in Patients with Type 2 Diabetes Mellitus

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
69

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 92801
        • Eccogene Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy male and female participants of non-childbearing potential
  • Age of 18 to 65 years
  • BMI of 18.0 to 32.0 kg/m2
  • Hemoglobin A1c ≤ 6.0%
  • Female participants who are postmenopausal, confirmed by FSH test, or surgically sterile, confirmed by medical documentation, 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
  • Able to understand and sign and date informed consent

Additional Inclusion Criteria for Part 2 (MAD)

  • Diagnosed Type 2 Diabetes Mellitus of 18 to 70 years of age inclusive
  • Type 2 Diabetes Mellitus with lifestyle modification only or with stable dose of metformin for ≥ 2 months prior to the study treatment
  • BMI of 24.0 to 40.0 kg/m2 with a minimum body weight of 50.0 kg (110 lbs)
  • HbA1c ≥ 7.0% and ≤ 10.5%, and fasting plasma glucose ≤ 270 mg/dL
  • Blood pressure (BP) with or without medication: Systolic BP ≤ 160 mmHg, AND Diastolic BP ≤ 100 mmHg
  • Not taking any active treatment regimen

Exclusion Criteria:

  • 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
  • Unable to refrain from taking any non-metformin anti-diabetic medication including insulin within ≥ 3 months prior to the study treatment
  • Serum calcitonin > 20 ng/L
  • Clinically relevant acute or chronic medical conditions or diseases of the cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, psychiatric, immune or dermatologic systems
  • Diagnosis of T1DM or secondary forms of diabetes
  • Individual or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia 2 (MEN2), or suspected MTC
  • History of pancreatitis
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 tablet. Matching Placebo will be given orally during each dosing day.
Experimental: SAD Cohorts 1 to 2: Participants receiving ECC5004
Participants in each SAD cohort will be randomized to receive up to 4 escalating doses of ECC5004 ranging from 1 mg to 300 mg.
Drug: ECC5004
ECC5004 will be administered as oral tablet(s) 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 28 days.
Drug: Placebo
Matching Placebo will be administered as oral tablet. Matching Placebo will be given orally during each dosing day.
Experimental: MAD Cohorts 1 to 4: Participants receiving ECC5004
Participants will be randomized to receive a once-daily dose of 1 of 4 escalating doses of ECC5004 ranging from 10 mg to 150 mg for 28 days.
Drug: ECC5004
ECC5004 will be administered as oral tablet(s) during each dosing day.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 Day 8 and MAD: Up to Day 35
Safety Assessment evaluated through adverse events, laboratory evaluations, vital signs, ECGs, and physical examination.
SAD: Up to Day 8 and MAD: Up to Day 35

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetic Parameters: AUC0-24
Time Frame: SAD: Up to Day 3 and MAD: Up to Day 30
AUC from time 0 to 24 hour dosing interval
SAD: Up to Day 3 and MAD: Up to Day 30
Pharmacokinetic Parameters: AUC0-tlast
Time Frame: SAD: Up to Day 3
AUC from time 0 to the time of last quantifiable non-zero concentration
SAD: Up to Day 3
Pharmacokinetic Parameters: AUC0-tau
Time Frame: MAD: Up to Day 30
AUC over a dosing interval from time 0 to time of last quantifiable concentration
MAD: Up to Day 30
Pharmacokinetic Parameters: AUC0-infinity
Time Frame: SAD: Up to Day 3
AUC from time 0 extrapolated to infinity
SAD: Up to Day 3
Pharmacokinetic Parameters: Cmax
Time Frame: SAD: Up to Day 3 and MAD: Up to Day 30
Maximum observed plasma concentration
SAD: Up to Day 3 and MAD: Up to Day 30
Pharmacokinetic Parameters: C24
Time Frame: SAD: Up to Day 3 and MAD: Up to Day 30
Observed concentration at 24 hours post dose
SAD: Up to Day 3 and MAD: Up to Day 30
Pharmacokinetic Parameters: Ctau
Time Frame: MAD: Up to Day 30
Observed concentration at the end of the dosing interval
MAD: Up to Day 30
Pharmacokinetic Parameters: tmax
Time Frame: SAD: Up to Day 3 and MAD: Up to Day 30
Time of the maximum observed plasma concentration
SAD: Up to Day 3 and MAD: Up to Day 30
Pharmacokinetic Parameters: tlag
Time Frame: SAD: Up to Day 3 and MAD: Up to Day 30
Lag time (time delay between dosing and first observed plasma concentration)
SAD: Up to Day 3 and MAD: Up to Day 30
Pharmacokinetic Parameters: t1/2
Time Frame: SAD: Up to Day 3 and MAD: Up to Day 30
Apparent terminal elimination half-life
SAD: Up to Day 3 and MAD: Up to Day 30
Pharmacokinetic Parameters: Clast
Time Frame: SAD: Up to Day 3
Last measurable non-zero concentration
SAD: Up to Day 3
Pharmacokinetic Parameters: tlast
Time Frame: SAD: Up to Day 3
Time of last measurable non-zero concentration
SAD: Up to Day 3
Pharmacokinetic Parameters: CL/F
Time Frame: SAD: Up to Day 3 and MAD: Up to Day 30
Apparent Clearance
SAD: Up to Day 3 and MAD: Up to Day 30
Pharmacodynamic Parameters: AUC0-4 for glucose
Time Frame: MAD: Up to Day 30
AUC from time 0 to 4 hour dosing interval
MAD: Up to Day 30
Pharmacodynamic Parameters: AUC0-4 for insulin
Time Frame: MAD: Up to Day 30
AUC from time 0 to 4 hour dosing interval
MAD: Up to Day 30
Pharmacodynamic Parameters: AUC0-4 for glucagon
Time Frame: MAD: Up to Day 30
AUC from time 0 to 4 hour dosing interval
MAD: Up to Day 30
Pharmacodynamic Parameters: AUC0-4 for C-peptide
Time Frame: MAD: Up to Day 30
AUC from time 0 to 4 hour dosing interval
MAD: Up to Day 30
Pharmacodynamic Parameters: Fasting plasma glucose
Time Frame: MAD: Up to Day 30
Change from baseline
MAD: Up to Day 30
Pharmacodynamic Parameters: Mean daily glucose
Time Frame: MAD: Up to Day 30
Change from baseline
MAD: Up to Day 30
Pharmacodynamic Parameters: Body Weight and Waist Circumference
Time Frame: MAD: Up to Day 30
Change from baseline
MAD: Up to Day 30
Pharmacodynamic Parameters: Fasting plasma glucose homeostatic model assessment
Time Frame: MAD: Up to Day 30
Fasting plasma glucose homeostatic model assessment
MAD: Up to Day 30
Pharmacodynamic Parameters: Fasting plasma insulin homeostatic model assessment
Time Frame: MAD: Up to Day 30
Fasting plasma insulin homeostatic model assessment
MAD: Up to Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eccogene

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Eccogene, Eccogene Clinical Trials

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 8, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 17, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EC0004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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