NCT05654831

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Eccogene · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Placebo	Matching Placebo will be administered as oral tablet. Matching Placebo will be given orally during each dosing day.
DRUG	ECC5004	ECC5004 will be administered as oral tablet(s) during each dosing day.

Timeline

• Start date: 2022-12-01
• Primary completion: 2023-11-01
• Completion: 2023-11-01
• First posted: 2022-12-16
• Last updated: 2024-07-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study