search
Back to results

FTIH of ECC5004 in Healthy and Diabetic Participants

Primary Purpose

Type 2 Diabetes Mellitus

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Placebo
ECC5004
Sponsored by
Eccogene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Eccogene Investigational SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Arm Label

SAD Cohorts 1 to 2: Participants receiving Placebo

SAD Cohorts 1 to 2: Participants receiving ECC5004

MAD Cohorts 1 to 4: Participants receiving Placebo

MAD Cohorts 1 to 4: Participants receiving ECC5004

Arm Description

Participants in each SAD cohort will be randomized to receive placebo.

Participants in each SAD cohort will be randomized to receive up to 4 escalating doses of ECC5004 ranging from 1 mg to 300 mg.

Participants will be randomized to receive a once-daily dose of placebo for 28 days.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Pharmacokinetic Parameters: AUC0-24
AUC from time 0 to 24 hour dosing interval
Pharmacokinetic Parameters: AUC0-tlast
AUC from time 0 to the time of last quantifiable non-zero concentration
Pharmacokinetic Parameters: AUC0-tau
AUC over a dosing interval from time 0 to time of last quantifiable concentration
Pharmacokinetic Parameters: AUC0-infinity
AUC from time 0 extrapolated to infinity
Pharmacokinetic Parameters: Cmax
Maximum observed plasma concentration
Pharmacokinetic Parameters: C24
Observed concentration at 24 hours post dose
Pharmacokinetic Parameters: Ctau
Observed concentration at the end of the dosing interval
Pharmacokinetic Parameters: tmax
Time of the maximum observed plasma concentration
Pharmacokinetic Parameters: tlag
Lag time (time delay between dosing and first observed plasma concentration)
Pharmacokinetic Parameters: t1/2
Apparent terminal elimination half-life
Pharmacokinetic Parameters: Clast
Last measurable non-zero concentration
Pharmacokinetic Parameters: tlast
Time of last measurable non-zero concentration
Pharmacokinetic Parameters: CL/F
Apparent Clearance
Pharmacodynamic Parameters: AUC0-4 for glucose
AUC from time 0 to 4 hour dosing interval
Pharmacodynamic Parameters: AUC0-4 for insulin
AUC from time 0 to 4 hour dosing interval
Pharmacodynamic Parameters: AUC0-4 for glucagon
AUC from time 0 to 4 hour dosing interval
Pharmacodynamic Parameters: AUC0-4 for C-peptide
AUC from time 0 to 4 hour dosing interval
Pharmacodynamic Parameters: Fasting plasma glucose
Change from baseline
Pharmacodynamic Parameters: Mean daily glucose
Change from baseline
Pharmacodynamic Parameters: Body Weight and Waist Circumference
Change from baseline
Pharmacodynamic Parameters: Fasting plasma glucose homeostatic model assessment
Fasting plasma glucose homeostatic model assessment
Pharmacodynamic Parameters: Fasting plasma insulin homeostatic model assessment
Fasting plasma insulin homeostatic model assessment

Full Information

First Posted
December 8, 2022
Last Updated
December 19, 2022
Sponsor
Eccogene
search

1. Study Identification

Unique Protocol Identification Number
NCT05654831
Brief Title
FTIH of ECC5004 in Healthy and Diabetic Participants
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
October 6, 2023 (Anticipated)
Study Completion Date
October 6, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eccogene

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SAD Cohorts 1 to 2: Participants receiving Placebo
Arm Type
Placebo Comparator
Arm Description
Participants in each SAD cohort will be randomized to receive placebo.
Arm Title
SAD Cohorts 1 to 2: Participants receiving ECC5004
Arm Type
Experimental
Arm Description
Participants in each SAD cohort will be randomized to receive up to 4 escalating doses of ECC5004 ranging from 1 mg to 300 mg.
Arm Title
MAD Cohorts 1 to 4: Participants receiving Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will be randomized to receive a once-daily dose of placebo for 28 days.
Arm Title
MAD Cohorts 1 to 4: Participants receiving ECC5004
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching Placebo will be administered as oral tablet. Matching Placebo will be given orally during each dosing day.
Intervention Type
Drug
Intervention Name(s)
ECC5004
Intervention Description
ECC5004 will be administered as oral tablet(s) during each dosing day.
Primary Outcome Measure Information:
Title
Number of participants with adverse events, with abnormal laboratory test results, abnormal ECGs, abnormal vital signs, and abnormal physical examinations
Description
Safety Assessment evaluated through adverse events, laboratory evaluations, vital signs, ECGs, and physical examination.
Time Frame
SAD: Up to Day 8 and MAD: Up to Day 35
Secondary Outcome Measure Information:
Title
Pharmacokinetic Parameters: AUC0-24
Description
AUC from time 0 to 24 hour dosing interval
Time Frame
SAD: Up to Day 3 and MAD: Up to Day 30
Title
Pharmacokinetic Parameters: AUC0-tlast
Description
AUC from time 0 to the time of last quantifiable non-zero concentration
Time Frame
SAD: Up to Day 3
Title
Pharmacokinetic Parameters: AUC0-tau
Description
AUC over a dosing interval from time 0 to time of last quantifiable concentration
Time Frame
MAD: Up to Day 30
Title
Pharmacokinetic Parameters: AUC0-infinity
Description
AUC from time 0 extrapolated to infinity
Time Frame
SAD: Up to Day 3
Title
Pharmacokinetic Parameters: Cmax
Description
Maximum observed plasma concentration
Time Frame
SAD: Up to Day 3 and MAD: Up to Day 30
Title
Pharmacokinetic Parameters: C24
Description
Observed concentration at 24 hours post dose
Time Frame
SAD: Up to Day 3 and MAD: Up to Day 30
Title
Pharmacokinetic Parameters: Ctau
Description
Observed concentration at the end of the dosing interval
Time Frame
MAD: Up to Day 30
Title
Pharmacokinetic Parameters: tmax
Description
Time of the maximum observed plasma concentration
Time Frame
SAD: Up to Day 3 and MAD: Up to Day 30
Title
Pharmacokinetic Parameters: tlag
Description
Lag time (time delay between dosing and first observed plasma concentration)
Time Frame
SAD: Up to Day 3 and MAD: Up to Day 30
Title
Pharmacokinetic Parameters: t1/2
Description
Apparent terminal elimination half-life
Time Frame
SAD: Up to Day 3 and MAD: Up to Day 30
Title
Pharmacokinetic Parameters: Clast
Description
Last measurable non-zero concentration
Time Frame
SAD: Up to Day 3
Title
Pharmacokinetic Parameters: tlast
Description
Time of last measurable non-zero concentration
Time Frame
SAD: Up to Day 3
Title
Pharmacokinetic Parameters: CL/F
Description
Apparent Clearance
Time Frame
SAD: Up to Day 3 and MAD: Up to Day 30
Title
Pharmacodynamic Parameters: AUC0-4 for glucose
Description
AUC from time 0 to 4 hour dosing interval
Time Frame
MAD: Up to Day 30
Title
Pharmacodynamic Parameters: AUC0-4 for insulin
Description
AUC from time 0 to 4 hour dosing interval
Time Frame
MAD: Up to Day 30
Title
Pharmacodynamic Parameters: AUC0-4 for glucagon
Description
AUC from time 0 to 4 hour dosing interval
Time Frame
MAD: Up to Day 30
Title
Pharmacodynamic Parameters: AUC0-4 for C-peptide
Description
AUC from time 0 to 4 hour dosing interval
Time Frame
MAD: Up to Day 30
Title
Pharmacodynamic Parameters: Fasting plasma glucose
Description
Change from baseline
Time Frame
MAD: Up to Day 30
Title
Pharmacodynamic Parameters: Mean daily glucose
Description
Change from baseline
Time Frame
MAD: Up to Day 30
Title
Pharmacodynamic Parameters: Body Weight and Waist Circumference
Description
Change from baseline
Time Frame
MAD: Up to Day 30
Title
Pharmacodynamic Parameters: Fasting plasma glucose homeostatic model assessment
Description
Fasting plasma glucose homeostatic model assessment
Time Frame
MAD: Up to Day 30
Title
Pharmacodynamic Parameters: Fasting plasma insulin homeostatic model assessment
Description
Fasting plasma insulin homeostatic model assessment
Time Frame
MAD: Up to Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eccogene Clinical Trials
Phone
86-21-61053022
Email
contact@eccogene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eccogene
Organizational Affiliation
Eccogene Clinical Trials
Official's Role
Study Director
Facility Information:
Facility Name
Eccogene Investigational Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eccogene

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

FTIH of ECC5004 in Healthy and Diabetic Participants

We'll reach out to this number within 24 hrs