FTIH of ECC5004 in Healthy and Diabetic Participants

Overseen By Eccogene Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Eccogene

Must be taking: Metformin

Must not be taking: Insulin

Disqualifiers: T1DM, MTC, Pancreatitis, others

Compensation: Varies

Number of Visits: Unknown

69 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a new drug called ECC5004. It aims to see if the drug is safe and how it behaves in both healthy people and those with Type 2 Diabetes. Researchers will study how the drug moves through the body and its effects.

Do I have to stop taking my current medications for the trial?

If you are taking any non-metformin anti-diabetic medications, you will need to stop them at least 3 months before the study. If you are on a stable dose of metformin, you can continue taking it.

Who Is on the Research Team?

Eccogene

Principal Investigator

Eccogene Clinical Trials

Are You a Good Fit for This Trial?

Inclusion Criteria

Not taking any active treatment regimen

Healthy male and female participants of non-childbearing potential

BMI of 18.0 to 32.0 kg/m2

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose (SAD) Treatment

Participants receive up to 4 escalating doses of ECC5004 ranging from 1 mg to 300 mg

Up to 8 days

Multiple visits (in-person)

Multiple Ascending Dose (MAD) Treatment

Participants receive a once-daily dose of ECC5004 ranging from 10 mg to 150 mg for 28 days

28 days

Daily visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 7 days

What Are the Treatments Tested in This Trial?

Interventions

• ECC5004
• Placebo

How Is the Trial Designed?

Group I: SAD Cohorts 1 to 2: Participants receiving ECC5004 Experimental Treatment 1 Intervention

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

Group II: MAD Cohorts 1 to 4: Participants receiving ECC5004 Experimental Treatment 1 Intervention

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.

Group III: MAD Cohorts 1 to 4: Participants receiving Placebo Placebo Group 1 Intervention

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

Group IV: SAD Cohorts 1 to 2: Participants receiving Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Eccogene

Lead Sponsor

Trials

5

Recruited

300+