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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05012423




Registration number
NCT05012423
Ethics application status
Date submitted
22/07/2021
Date registered
19/08/2021

Titles & IDs
Public title
FTIH Study of ECC0509 in Healthy Volunteers
Scientific 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
Secondary ID [1] 0 0
EC0001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nonalcoholic Steatohepatitis 0 0
Osteoarthritis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - ECC0509
Treatment: Drugs - Placebo
Treatment: Drugs - ECC0509

Placebo comparator: SAD Cohorts 1 to 7: Participants Receiving Placebo - Participants in each SAD cohort will be randomized to receive placebo.

Experimental: SAD Cohorts 1 to 7: Participants receiving ECC0509 - Participants in each SAD cohort will be randomized to receive 1 of 7 escalating doses (1 mg, 4 mg, 10 mg, 20 mg, 40 mg, 60 mg, or 80 mg).

Placebo comparator: MAD Cohorts 1 to 3: Participants receiving Placebo - Participants will be randomized to receive a once-daily dose of placebo for 14 days.

Experimental: MAD Cohorts 1 to 3: Participants receiving ECC0509 - Participants will be randomized to receive a once-daily dose of 1 of 3 escalating doses (8 mg, 20 mg, or 40 mg) for 14 days.


Treatment: Drugs: Placebo
Matching Placebo

Placebo will be administered as oral capsules.

Treatment: Drugs: ECC0509
ECC0509 1 mg and 10 mg capsules

ECC0509 will be administered as oral capsules.

Treatment: Drugs: Placebo
Matching Placebo

Placebo will be given orally during each dosing day.

Treatment: Drugs: ECC0509
ECC0509 1 mg and 10 mg capsules

Placebo will be given orally during each dosing day.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of subjects with adverse events and serious adverse events
Timepoint [1] 0 0
SAD: Up to Day 8. MAD: Up to Day 21.
Primary outcome [2] 0 0
Number of subjects with abnormal values for blood pressure
Timepoint [2] 0 0
SAD: Up to Day 8. MAD: Up to Day 21.
Primary outcome [3] 0 0
Number of subjects with abnormal values for pulse rate
Timepoint [3] 0 0
SAD: Up to Day 8. MAD: Up to Day 21.
Primary outcome [4] 0 0
Number of subjects with abnormal values for respiratory rate
Timepoint [4] 0 0
SAD: Up to Day 8. MAD: Up to Day 21.
Primary outcome [5] 0 0
Number of subjects with abnormal values for tympanic temperature
Timepoint [5] 0 0
SAD: Up to Day 8. MAD: Up to Day 21.
Primary outcome [6] 0 0
Number of subjects with abnormal values for electrocardiogram parameters
Timepoint [6] 0 0
SAD: Up to Day 8. MAD: Up to Day 21.
Primary outcome [7] 0 0
Number of subjects with abnormal findings for clinical chemistry parameters
Timepoint [7] 0 0
SAD: Up to Day 8. MAD: Up to Day 21.
Primary outcome [8] 0 0
Number of subjects with abnormal findings for hematology parameters
Timepoint [8] 0 0
SAD: Up to Day 8. MAD: Up to Day 21.
Primary outcome [9] 0 0
Number of subjects with abnormal findings for coagulation parameters
Timepoint [9] 0 0
SAD: Up to Day 8. MAD: Up to Day 21.
Primary outcome [10] 0 0
Number of subjects with abnormal findings for urinalysis parameters
Timepoint [10] 0 0
SAD: Up to Day 8. MAD: Up to Day 21.
Secondary outcome [1] 0 0
Pharmacokinetic assessment 1
Timepoint [1] 0 0
SAD: Up to Day 8. MAD: Up to Day 21.
Secondary outcome [2] 0 0
Pharmacokinetic assessment 2
Timepoint [2] 0 0
SAD: Up to Day 8. MAD: Up to Day 21.
Secondary outcome [3] 0 0
Pharmacokinetic assessment 3
Timepoint [3] 0 0
SAD: Up to Day 8. MAD: Up to Day 21.
Secondary outcome [4] 0 0
Pharmacokinetic assessment 4
Timepoint [4] 0 0
SAD: Up to Day 8. MAD: Up to Day 21.
Secondary outcome [5] 0 0
Pharmacokinetic assessment 5
Timepoint [5] 0 0
SAD: Up to Day 8. MAD: Up to Day 21.
Secondary outcome [6] 0 0
Pharmacokinetic assessment 6
Timepoint [6] 0 0
SAD: Up to Day 8. MAD: Up to Day 21.
Secondary outcome [7] 0 0
Pharmacodynamic assessment
Timepoint [7] 0 0
SAD: Up to Day 8. MAD: Up to Day 21.

Eligibility
Key inclusion criteria
Key

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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/07/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/07/2023
Sample size
Target
Accrual to date
Final
89
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX Clinical Research - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eccogene
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Syneos Health
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Participant Engagement Manager
Address 0 0
Country 0 0
Phone 0 0
1800150433
Fax 0 0
Email 0 0
cmax@cmax.com.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05012423