FTIH Study of ECC0509 in Healthy Volunteers

NCT05012423 | Completed Phase 1 DMC

• 1 other identifier: EC0001
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single And Multiple Ascending Dose, First-Time-In-Human Study to Assess The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ECC0509 in Healthy Volunteers.

Conditions

Nonalcoholic Steatohepatitis; Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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. MAD: Up to Day 21.

Secondary Outcomes (18)

• ECC0509 PK parameters: Cl/F

  SAD: Up to Day 8.

• ECC0509 PK parameters: Vz/F

  SAD: Up to Day 8.

• ECC0509 PK parameter: AUC0-24

  MAD: Up to Day 21

• ECC0509 PK parameter: Cmax ss

  MAD: Up to Day 21

• ECC0509 PK parameter: Tmax ss

  MAD: Up to Day 21

Study Arms (4)

SAD Cohorts 1 to 6: Participants Receiving Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

SAD Cohorts 1 to 6: Participants receiving ECC0509

EXPERIMENTAL

Participants in each SAD cohort will be randomized to receive 1 of 6 escalating doses (1 mg, 4 mg, 10 mg, 20 mg, 40 mg, or 60 mg).

Drug: ECC0509

MAD Cohorts 1 to 4: Participants receiving Placebo

PLACEBO COMPARATOR

Participants will be randomized to receive a once-daily dose of placebo for 14 days.

Drug: Placebo

MAD Cohorts 1 to 4: Participants receiving ECC0509

EXPERIMENTAL

Participants will be randomized to receive a once-daily dose of 1 of 4 escalating doses (3 mg, 10 mg, 30 mg, 60 mg) for 14 days.

Drug: ECC0509

Interventions

Placebo DRUG

Matching Placebo will be administered as oral capsules.

SAD Cohorts 1 to 6: Participants Receiving Placebo

ECC0509 DRUG

ECC0509 1 mg and 10 mg capsules. ECC0509 will be administered as oral capsules.

SAD Cohorts 1 to 6: Participants receiving ECC0509

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male or non-childbearing potential female
• Age ≥18 and ≤65 years old
• BMI ≥18.0 and ≤32.0 kg/m2
• Male participants agree to use contraception
• No clinically significant abnormal findings in physical examination, 12-lead electrocardiogram (ECG), laboratory tests, or medical history
• Able to understand and sign informed consent

You may not qualify if:

• Significant allergic reactions to any drug.
• History of significant drug abuse or alcohol abuse within 1 year prior to screening
• Concomitant participation in any investigational study of any nature
• Use of any concomitant medication except for the occasional use of acetaminophen (up to 2 g daily)
• Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or more of whole blood within 8 weeks prior to dosing.
• Any clinically significant abnormal findings in the participant's physical examination, laboratory tests, pregnancy test, urine drug screen, alcohol breath test, or medical history which, in the opinion of the Investigator, would prevent the subject from participating in the study.

Sponsors & Collaborators

• Eccogene: lead

Study Sites (1)

CMAX Clinical Research

Adelaide, South Australia, 5000, Australia

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Osteoarthritis

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: August 19, 2021
• Study Start: July 26, 2021
• Primary Completion: July 22, 2023
• Study Completion: July 22, 2023
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)