FTIH Study of ECC0509 in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-26

Study Completion Date

2023-07-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of HEC88473 in Healthy Subjects

NCT04829123

Non-alcoholic Steatohepatitis

COMPLETED PHASE1

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD9550 Following Single Ascending Dose Administration to Healthy Participants

NCT05848440

Non-alcoholic Steatohepatitis

COMPLETED PHASE1

A First-in-Human Single and Multiple Ascending Dose Study of MT-501

NCT06762457

Healthy Volunteers

COMPLETED PHASE1

Evaluate the Safety, Tolerability, and PK of EP547 in Healthy Subjects and Subjects With Cholestatic or Uremic Pruritus

NCT04510090

Pruritus Cholestasis Kidney Failure

COMPLETED PHASE1

A Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Multiple Ascending Doses of AZD5069 in Healthy Volunteers

NCT01051505

Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study will be conducted in up to seven cohorts of Single Ascending Dose (SAD) \& 3 cohorts of Multiple Ascending Dose (MAD). SAD will consist of a staggered dosing approach with a dose range from 1mg to 80mg. Staggered dosing approach will not be deployed for MAD cohorts with a dose range of 8mg to 40mg. In the MAD cohort, the effect of food will also be assessed by comparing the PK profile of Day 10 fed conditions against Day 14 fasted conditions.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nonalcoholic Steatohepatitis Osteoarthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SAD Cohorts 1 to 6: Participants Receiving Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching Placebo will be administered as oral capsules.

SAD Cohorts 1 to 6: Participants receiving ECC0509

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).

Group Type EXPERIMENTAL

ECC0509

Intervention Type DRUG

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

MAD Cohorts 1 to 4: Participants receiving Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching Placebo will be given orally during each dosing day.

MAD Cohorts 1 to 4: Participants receiving ECC0509

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.

Group Type EXPERIMENTAL

ECC0509

Intervention Type DRUG

ECC0509 1 mg and 10 mg capsules

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Placebo

Matching Placebo will be administered as oral capsules.

Intervention Type DRUG

ECC0509

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

Intervention Type DRUG

Placebo

Matching Placebo will be given orally during each dosing day.

Intervention Type DRUG

ECC0509

ECC0509 1 mg and 10 mg capsules

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

1. Significant allergic reactions to any drug.
2. History of significant drug abuse or alcohol abuse within 1 year prior to screening
3. Concomitant participation in any investigational study of any nature
4. Use of any concomitant medication except for the occasional use of acetaminophen (up to 2 g daily)
5. 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.
6. 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes