FTIH Study of ECC0509 in Healthy Volunteers

Eccogene

Status and phase: Completed; Phase 1

Conditions: Osteoarthritis; Nonalcoholic Steatohepatitis

Treatments: Drug: ECC0509; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05012423

EC0001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 89 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key 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

Key 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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89 participants in 4 patient groups, including a placebo group

SAD Cohorts 1 to 6: Participants Receiving Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: Placebo

SAD Cohorts 1 to 6: Participants receiving ECC0509

Experimental group

Description:

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).

Treatment:

Drug: ECC0509

Drug: ECC0509

MAD Cohorts 1 to 4: Participants receiving Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: Placebo

MAD Cohorts 1 to 4: Participants receiving ECC0509

Experimental group

Description:

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.

Treatment:

Drug: ECC0509

Drug: ECC0509