FTIH of ECC5004 in Healthy and Diabetic Participants

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05654831
• Other study ID #: EC0004
• Status: Recruiting
• Phase: Phase 1
• Start date: December 1, 2022
• Est. completion date: October 6, 2023

Study information

• Verified date: December 2022
• Source: Eccogene
• Contact: Eccogene Clinical Trials
• Phone: 86-21-61053022
• Email: contact[@]eccogene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: October 6, 2023
• Est. primary completion date: October 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Placebo
Matching Placebo will be administered as oral tablet. Matching Placebo will be given orally during each dosing day.
• ECC5004
ECC5004 will be administered as oral tablet(s) during each dosing day.

Locations

Country	Name	City	State
United States	Eccogene Investigational Site	Anaheim	California

Sponsors (1)

Lead Sponsor	Collaborator
Eccogene

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pharmacokinetic Parameters: AUC0-24	AUC from time 0 to 24 hour dosing interval	SAD: Up to Day 3 and MAD: Up to Day 30
Secondary	Pharmacokinetic Parameters: AUC0-tlast	AUC from time 0 to the time of last quantifiable non-zero concentration	SAD: Up to Day 3
Secondary	Pharmacokinetic Parameters: AUC0-tau	AUC over a dosing interval from time 0 to time of last quantifiable concentration	MAD: Up to Day 30
Secondary	Pharmacokinetic Parameters: AUC0-infinity	AUC from time 0 extrapolated to infinity	SAD: Up to Day 3
Secondary	Pharmacokinetic Parameters: Cmax	Maximum observed plasma concentration	SAD: Up to Day 3 and MAD: Up to Day 30
Secondary	Pharmacokinetic Parameters: C24	Observed concentration at 24 hours post dose	SAD: Up to Day 3 and MAD: Up to Day 30
Secondary	Pharmacokinetic Parameters: Ctau	Observed concentration at the end of the dosing interval	MAD: Up to Day 30
Secondary	Pharmacokinetic Parameters: tmax	Time of the maximum observed plasma concentration	SAD: Up to Day 3 and MAD: Up to Day 30
Secondary	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
Secondary	Pharmacokinetic Parameters: t1/2	Apparent terminal elimination half-life	SAD: Up to Day 3 and MAD: Up to Day 30
Secondary	Pharmacokinetic Parameters: Clast	Last measurable non-zero concentration	SAD: Up to Day 3
Secondary	Pharmacokinetic Parameters: tlast	Time of last measurable non-zero concentration	SAD: Up to Day 3
Secondary	Pharmacokinetic Parameters: CL/F	Apparent Clearance	SAD: Up to Day 3 and MAD: Up to Day 30
Secondary	Pharmacodynamic Parameters: AUC0-4 for glucose	AUC from time 0 to 4 hour dosing interval	MAD: Up to Day 30
Secondary	Pharmacodynamic Parameters: AUC0-4 for insulin	AUC from time 0 to 4 hour dosing interval	MAD: Up to Day 30
Secondary	Pharmacodynamic Parameters: AUC0-4 for glucagon	AUC from time 0 to 4 hour dosing interval	MAD: Up to Day 30
Secondary	Pharmacodynamic Parameters: AUC0-4 for C-peptide	AUC from time 0 to 4 hour dosing interval	MAD: Up to Day 30
Secondary	Pharmacodynamic Parameters: Fasting plasma glucose	Change from baseline	MAD: Up to Day 30
Secondary	Pharmacodynamic Parameters: Mean daily glucose	Change from baseline	MAD: Up to Day 30
Secondary	Pharmacodynamic Parameters: Body Weight and Waist Circumference	Change from baseline	MAD: Up to Day 30
Secondary	Pharmacodynamic Parameters: Fasting plasma glucose homeostatic model assessment	Fasting plasma glucose homeostatic model assessment	MAD: Up to Day 30
Secondary	Pharmacodynamic Parameters: Fasting plasma insulin homeostatic model assessment	Fasting plasma insulin homeostatic model assessment	MAD: Up to Day 30