Clinical trial NCT05012423: FTIH Study of ECC0509 in Healthy Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Nonalcoholic Steatohepatitis
Osteoarthritis
Lead sponsor: Eccogene
Sponsor class: INDUSTRY
First posted: 2021-08-19
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Detailed description: This study will be conducted in up to seven cohorts of Single Ascending Dose (SAD) \&amp; 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.

Eligibility 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.

Primary outcomes:
measure: Number of participants with adverse events, with abnormal laboratory test results, abnormal ECGs, abnormal vital signs, and abnormal physical examinations
timeFrame: SAD: Up to Day 8. MAD: Up to Day 21.
Secondary outcomes:
measure: ECC0509 PK parameters: Cl/F
timeFrame: SAD: Up to Day 8.
measure: ECC0509 PK parameters: Vz/F
timeFrame: SAD: Up to Day 8.
measure: ECC0509 PK parameter: AUC0-24
timeFrame: MAD: Up to Day 21
measure: ECC0509 PK parameter: Cmax ss
timeFrame: MAD: Up to Day 21
measure: ECC0509 PK parameter: Tmax ss
timeFrame: MAD: Up to Day 21
measure: ECC0509 PK parameter: Tlag ss
timeFrame: MAD: Up to Day 21
measure: ECC0509 PK parameters: Cmax
timeFrame: SAD: Up to Day 8. MAD: Up to Day 21
measure: ECC0509 PK parameter: Tmax
timeFrame: SAD: Up to Day 8. MAD: Up to Day 21
measure: ECC0509 PK parameter: AUC0-t
timeFrame: SAD: Up to Day 8. MAD: Up to Day 21
measure: ECC0509 PK parameter: Cmin ss
timeFrame: MAD: Up to Day 21
measure: ECC0509 PK parameter: T½ el
timeFrame: SAD: Up to Day 8. MAD: Up to Day 21
measure: ECC0509 PK parameter: Kel
timeFrame: SAD: Up to Day 8. MAD: Up to Day 21
measure: ECC0509 PK parameter: Clss/F
timeFrame: MAD: Up to Day 21
measure: ECC0509 PK parameter: Vz ss/F
timeFrame: MAD: Up to Day 21
measure: ECC0509 PK parameter: AUC0-τ
timeFrame: MAD: Up to Day 21
measure: ECC0509 PK parameters: AUC0-inf
timeFrame: SAD: Up to Day 8. MAD: Up to Day 21
measure: ECC0509 PK parameters: Residual area
timeFrame: SAD: Up to Day 8. MAD: Up to Day 21
measure: PD Parameter: SSAO
timeFrame: SAD: Up to Day 8. MAD: Up to Day 21.
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: CMAX Clinical Research
state: South Australia
Study officials:
References: