Clinical trial NCT05654831: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Eccogene
Sponsor class: INDUSTRY
First posted: 2022-12-16
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Number of participants with adverse events, with abnormal laboratory test results, abnormal ECGs, abnormal vital signs, and abnormal physical examinations
timeFrame: SAD: Up to Day 8 and MAD: Up to Day 35
Secondary outcomes:
measure: Pharmacokinetic Parameters: AUC0-24
timeFrame: SAD: Up to Day 3 and MAD: Up to Day 30
measure: Pharmacokinetic Parameters: AUC0-tlast
timeFrame: SAD: Up to Day 3
measure: Pharmacokinetic Parameters: AUC0-tau
timeFrame: MAD: Up to Day 30
measure: Pharmacokinetic Parameters: AUC0-infinity
timeFrame: SAD: Up to Day 3
measure: Pharmacokinetic Parameters: Cmax
timeFrame: SAD: Up to Day 3 and MAD: Up to Day 30
measure: Pharmacokinetic Parameters: C24
timeFrame: SAD: Up to Day 3 and MAD: Up to Day 30
measure: Pharmacokinetic Parameters: Ctau
timeFrame: MAD: Up to Day 30
measure: Pharmacokinetic Parameters: tmax
timeFrame: SAD: Up to Day 3 and MAD: Up to Day 30
measure: Pharmacokinetic Parameters: tlag
timeFrame: SAD: Up to Day 3 and MAD: Up to Day 30
measure: Pharmacokinetic Parameters: t1/2
timeFrame: SAD: Up to Day 3 and MAD: Up to Day 30
measure: Pharmacokinetic Parameters: Clast
timeFrame: SAD: Up to Day 3
measure: Pharmacokinetic Parameters: tlast
timeFrame: SAD: Up to Day 3
measure: Pharmacokinetic Parameters: CL/F
timeFrame: SAD: Up to Day 3 and MAD: Up to Day 30
measure: Pharmacodynamic Parameters: AUC0-4 for glucose
timeFrame: MAD: Up to Day 30
measure: Pharmacodynamic Parameters: AUC0-4 for insulin
timeFrame: MAD: Up to Day 30
measure: Pharmacodynamic Parameters: AUC0-4 for glucagon
timeFrame: MAD: Up to Day 30
measure: Pharmacodynamic Parameters: AUC0-4 for C-peptide
timeFrame: MAD: Up to Day 30
measure: Pharmacodynamic Parameters: Fasting plasma glucose
timeFrame: MAD: Up to Day 30
measure: Pharmacodynamic Parameters: Mean daily glucose
timeFrame: MAD: Up to Day 30
measure: Pharmacodynamic Parameters: Body Weight and Waist Circumference
timeFrame: MAD: Up to Day 30
measure: Pharmacodynamic Parameters: Fasting plasma glucose homeostatic model assessment
timeFrame: MAD: Up to Day 30
measure: Pharmacodynamic Parameters: Fasting plasma insulin homeostatic model assessment
timeFrame: MAD: Up to Day 30
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Eccogene Investigational Site
state: California
Study officials:
affiliation: Eccogene Clinical Trials
name: Eccogene
role: STUDY_DIRECTOR
References: