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Unknown

MAD Cohorts 1 to 4: Participants receiving ECC5004 for Diabetes

Phase 1
Waitlist Available
Research Sponsored by Eccogene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up sad: up to day 8 and mad: up to day 35

Summary

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.

Eligible Conditions
  • Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~sad: up to day 8 and mad: up to day 35
This trial's timeline: 3 weeks for screening, Varies for treatment, and sad: up to day 8 and mad: up to day 35 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with adverse events, with abnormal laboratory test results, abnormal ECGs, abnormal vital signs, and abnormal physical examinations
Secondary study objectives
Pharmacodynamic Parameters: AUC0-4 for C-peptide
Pharmacodynamic Parameters: AUC0-4 for glucagon
Pharmacodynamic Parameters: AUC0-4 for glucose
+19 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: SAD Cohorts 1 to 2: Participants receiving ECC5004Experimental Treatment1 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 ECC5004Experimental Treatment1 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 PlaceboPlacebo Group1 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 PlaceboPlacebo Group1 Intervention
Participants in each SAD cohort will be randomized to receive placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ECC5004
2022
Completed Phase 1
~140

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

EccogeneLead Sponsor
4 Previous Clinical Trials
226 Total Patients Enrolled

Media Library

ECC5004 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05654831 — Phase 1
Diabetes Research Study Groups: MAD Cohorts 1 to 4: Participants receiving ECC5004, SAD Cohorts 1 to 2: Participants receiving ECC5004, MAD Cohorts 1 to 4: Participants receiving Placebo, SAD Cohorts 1 to 2: Participants receiving Placebo
Diabetes Clinical Trial 2023: ECC5004 Highlights & Side Effects. Trial Name: NCT05654831 — Phase 1
ECC5004 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05654831 — Phase 1
~24 spots leftby Nov 2025
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