FTIH of ECC5004 in Healthy and Diabetic Participants

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: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Placebo; Drug: ECC5004

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: Interventional
• Enrollment (Actual): 69
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / 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 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

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	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

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic Parameters: AUC0-24	AUC from time 0 to 24 hour dosing interval	SAD: Up to Day 3 and MAD: Up to Day 30
Pharmacokinetic Parameters: AUC0-tlast	AUC from time 0 to the time of last quantifiable non-zero concentration	SAD: Up to Day 3
Pharmacokinetic Parameters: AUC0-tau	AUC over a dosing interval from time 0 to time of last quantifiable concentration	MAD: Up to Day 30
Pharmacokinetic Parameters: AUC0-infinity	AUC from time 0 extrapolated to infinity	SAD: Up to Day 3
Pharmacokinetic Parameters: Cmax	Maximum observed plasma concentration	SAD: Up to Day 3 and MAD: Up to Day 30
Pharmacokinetic Parameters: C24	Observed concentration at 24 hours post dose	SAD: Up to Day 3 and MAD: Up to Day 30
Pharmacokinetic Parameters: Ctau	Observed concentration at the end of the dosing interval	MAD: Up to Day 30
Pharmacokinetic Parameters: tmax	Time of the maximum observed plasma concentration	SAD: Up to Day 3 and MAD: Up to Day 30
Pharmacokinetic Parameters: tlag	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	Apparent terminal elimination half-life	SAD: Up to Day 3 and MAD: Up to Day 30
Pharmacokinetic Parameters: Clast	Last measurable non-zero concentration	SAD: Up to Day 3
Pharmacokinetic Parameters: tlast	Time of last measurable non-zero concentration	SAD: Up to Day 3
Pharmacokinetic Parameters: CL/F	Apparent Clearance	SAD: Up to Day 3 and MAD: Up to Day 30
Pharmacodynamic Parameters: AUC0-4 for glucose	AUC from time 0 to 4 hour dosing interval	MAD: Up to Day 30
Pharmacodynamic Parameters: AUC0-4 for insulin	AUC from time 0 to 4 hour dosing interval	MAD: Up to Day 30
Pharmacodynamic Parameters: AUC0-4 for glucagon	AUC from time 0 to 4 hour dosing interval	MAD: Up to Day 30
Pharmacodynamic Parameters: AUC0-4 for C-peptide	AUC from time 0 to 4 hour dosing interval	MAD: Up to Day 30
Pharmacodynamic Parameters: Fasting plasma glucose	Change from baseline	MAD: Up to Day 30
Pharmacodynamic Parameters: Mean daily glucose	Change from baseline	MAD: Up to Day 30
Pharmacodynamic Parameters: Body Weight and Waist Circumference	Change from baseline	MAD: Up to Day 30
Pharmacodynamic Parameters: Fasting plasma glucose homeostatic model assessment	Fasting plasma glucose homeostatic model assessment	MAD: Up to Day 30
Pharmacodynamic Parameters: Fasting plasma insulin homeostatic model assessment	Fasting plasma insulin homeostatic model assessment	MAD: Up to Day 30

Collaborators and Investigators

• Sponsor: Eccogene
• Investigators: Study Director: Eccogene, Eccogene Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): November 1, 2023
• Study Completion (Actual): November 1, 2023

Study Registration Dates

• First Submitted: December 8, 2022
• First Submitted That Met QC Criteria: December 8, 2022
• First Posted (Actual): December 16, 2022

Study Record Updates

• Last Update Posted (Actual): July 17, 2024
• Last Update Submitted That Met QC Criteria: July 15, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID 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