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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05807971




Registration number
NCT05807971
Ethics application status
Date submitted
29/03/2023
Date registered
11/04/2023
Date last updated
3/05/2024

Titles & IDs
Public title
Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ATH-063 in Healthy Subjects
Scientific title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of ATH-063 in Healthy Subjects
Secondary ID [1] 0 0
ATH-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory Bowel Diseases 0 0
Crohn Disease 0 0
Ulcerative Colitis 0 0
Autoimmune Diseases 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ATH-063
Treatment: Drugs - Placebo

Experimental: SAD cohort - SAD cohorts 1-4. Subjects in each cohort will be randomized to receive a single oral dose of ATH-063 (capsule) under fasting conditions at the planned dose levels.

Experimental: MAD Cohort - MAD cohorts 1-4. Subjects in each cohort will be randomized to receive multiple oral doses of ATH-063 (Capsule) under fasting conditions once daily (QD) for 10 consecutive days at planned dose levels.

Experimental: Food Effect - An intermediary dose level that has already been administered in this study will be selected for the food-effect evaluation based on the available PK and safety data. This will be conducted under fasting and fed conditions.

Placebo Comparator: SAD cohort (Placebo) - SAD cohorts 1-4. Subjects in each cohort will be randomized to receive a single oral dose of placebo (Capsule identical to active ATH-063) under fasting conditions at the planned dose levels.

Placebo Comparator: MAD cohort (Placebo) - MAD cohorts 1-4. Subjects in each cohort will be randomized to receive multiple oral doses of placebo (Capsule identical to active ATH-063) under fasting conditions once daily (QD) for 10 consecutive days at planned dose levels.


Treatment: Drugs: ATH-063
12.5 and 50 mg Capsules, anticipated dose range to be from 25 to 250 mg.

Treatment: Drugs: Placebo
Identical capsule to the drug without the active ingredient.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate the safety and tolerability of ATH-063 following oral administration of single and multiple ascending doses in healthy participants.
Timepoint [1] 0 0
SAD: Up to 15 ± 1 day, MAD: Up to 24 ± 1 day, FE: Up to 14 ± 1 day
Secondary outcome [1] 0 0
Pharmacokinetic assessment 1
Timepoint [1] 0 0
SAD: Up to 15 ± 1 day, MAD: Up to 24 ± 1 day, FE: Up to 14 ± 1 day
Secondary outcome [2] 0 0
Pharmacokinetic assessment 2
Timepoint [2] 0 0
SAD: Up to 15 ± 1 day, MAD: Up to 24 ± 1 day, FE: Up to 14 ± 1 day
Secondary outcome [3] 0 0
Pharmacokinetic assessment 3
Timepoint [3] 0 0
SAD: Up to 15 ± 1 day, MAD: Up to 24 ± 1 day, FE: Up to 14 ± 1 day
Secondary outcome [4] 0 0
Pharmacokinetic assessment 4
Timepoint [4] 0 0
SAD: Up to 15 ± 1 day, MAD: Up to 24 ± 1 day, FE: Up to 14 ± 1 day
Secondary outcome [5] 0 0
Pharmacokinetic assessment 5
Timepoint [5] 0 0
SAD: Up to 15 ± 1 day, MAD: Up to 24 ± 1 day, FE: Up to 14 ± 1 day
Secondary outcome [6] 0 0
Pharmacokinetic assessment 6
Timepoint [6] 0 0
SAD: Up to 15 ± 1 day, MAD: Up to 24 ± 1 day, FE: Up to 14 ± 1 day
Secondary outcome [7] 0 0
Pharmacokinetic assessment 7
Timepoint [7] 0 0
SAD: Up to 15 ± 1 day, MAD: Up to 24 ± 1 day, FE: Up to 14 ± 1 day
Secondary outcome [8] 0 0
Pharmacokinetic assessment 8
Timepoint [8] 0 0
SAD: Up to 15 ± 1 day, FE: Up to 14 ± 1 day
Secondary outcome [9] 0 0
Pharmacokinetic assessment 9
Timepoint [9] 0 0
MAD: Up to 24 ± 1 day
Secondary outcome [10] 0 0
Pharmacokinetic assessment 10
Timepoint [10] 0 0
SAD: Up to 15 ± 1 day, FE: Up to 14 ± 1 day
Secondary outcome [11] 0 0
Pharmacokinetic assessment 11
Timepoint [11] 0 0
MAD: Up to 24 ± 1 day
Secondary outcome [12] 0 0
Pharmacokinetic assessment 12
Timepoint [12] 0 0
MAD: Up to 24 ± 1 day
Secondary outcome [13] 0 0
Pharmacokinetic assessment 13
Timepoint [13] 0 0
MAD: Up to 24 ± 1 day
Secondary outcome [14] 0 0
Pharmacokinetic assessment 14
Timepoint [14] 0 0
MAD: Up to 24 ± 1 day
Secondary outcome [15] 0 0
Pharmacokinetic assessment 15
Timepoint [15] 0 0
MAD: Up to 24 ± 1 day
Secondary outcome [16] 0 0
Pharmacokinetic assessment 16
Timepoint [16] 0 0
MAD: Up to 24 ± 1 day
Secondary outcome [17] 0 0
Pharmacokinetic assessment 17
Timepoint [17] 0 0
FE: Up to 14 ± 1 day

Eligibility
Key inclusion criteria
1. Male or female, non-smoker (no use of tobacco or nicotine products within 3 months
prior to screening) or social smoker (smokers with 1-5 cigarettes a week), AND with a
negative urine cotinine test at check-in, =18 and =55 years of age, with BMI >18.5 and
<32.0 kg/m2 and body weight =50.0 kg for males and =45.0 kg for females and a maximum
weight of 120 kg.

2. Healthy as defined by:

1. the absence of clinically significant illness and surgery within 4 weeks prior to
study drug administration.

2. the absence of clinically significant history of neurological, endocrine,
cardiovascular, respiratory, hematological, immunological, psychiatric,
gastrointestinal, renal, hepatic, and metabolic disease. A history of migraines,
childhood asthma, or non-hospitalized depression would not be considered
clinically significant.

3. Female participants of non-childbearing potential must be:

1. post-menopausal (spontaneous amenorrhea for at least 12 months prior to dosing)
with confirmation by documented follicle-stimulating hormone (FSH) levels = 40
mIU/mL; or

2. surgically sterile (bilateral oophorectomy, bilateral salpingectomy,
hysterectomy, or tubal ligation) at least 3 months prior to dosing.

4. Sexually active females of childbearing potential and non-sterile males must be
willing to use an acceptable contraceptive method throughout the study as detailed in
section 8.1.

5. Able to understand the study procedures and provide signed informed consent to
participate in the study.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Any clinically significant abnormal finding at physical examination.

2. Clinically significant abnormal laboratory test results or positive serology test
results for HBsAg, HCV antibody, or HIV antigen and antibody, at screening.

3. Positive pregnancy test or lactating female subject

4. Positive urine drug screen, urine cotinine test, or alcohol breath test (one repeat is
allowed).

5. History of significant allergic reactions (e.g., anaphylactic reaction,
hypersensitivity, angioedema) to any drug.

6. Clinically significant ECG abnormalities or vital signs abnormalities (systolic BP
lower than 90 or over 160 mmHg, diastolic BP lower than 50 or over 95 mmHg, HR less
than 45 or over 100 bpm, or RR less than 12 or over 22 bpm) at screening.

7. History of drug abuse within 1 year prior to screening or recreational use of soft
drugs (such as marijuana) within 1 month or hard drugs (such as cocaine, phencyclidine
[PCP], crack, opioid derivatives including heroin, and amphetamine derivatives) within
3 months prior to screening.

8. History of alcohol abuse within 1 year prior to screening or regular use of alcohol
within 6 months prior to screening that exceeds 10 units for women or 15 units for men
of alcohol per week (1 unit = 375 mL of beer 3.5%, 100 mL of wine 13.5%, or 45 mL of
distilled alcohol 40%). Low risk level = 10 unites per week for men and women.

9. Use of medications for the timeframes specified below, with the exception of hormonal
contraceptives and medications exempted by the Investigator on a case-by-case basis
because they are judged unlikely to affect the PK profile of the study drug or subject
safety (e.g., topical drug products without significant systemic absorption):

1. depot injection or implant within 3 months prior to the first dosing;

2. live attenuated vaccines within 1 month prior to the first dosing;

3. any drug known to induce or inhibit hepatic drug metabolism, including St. John's
wort, within 30 days prior to the first dosing;

4. prescription medications within 14 days prior to the first dosing;

5. any other vaccine, including COVID-19 vaccine, within 14 days prior to the first
dosing;

6. over-the-counter (OTC) medications and natural health products (including herbal
remedies such as, homeopathic and traditional medicines, probiotics, food
supplements such as vitamins, minerals, amino acids, essential fatty acids, and
protein supplements used in sports) within 7 days prior to the first dosing, with
the exception of the occasional use of paracetamol (up to 2 g daily).

10. Participation in a clinical research study involving the administration of an
investigational or marketed drug or device within 30 days or 5 x T1/2 whichever is
longer prior to the first dosing, administration of a biological product in the
context of a clinical research study within 90 days or 5 x T1/2 whichever is longer
prior to the first dosing, or concomitant participation in an investigational study
involving no drug or device administration.

11. 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.

12. Any reason 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 assessing the outcomes
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
6/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/02/2024
Sample size
Target
Accrual to date
Final
76
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
Athos Therapeutics Inc
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Syneos Health
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Athos Therapeutics Australia Pty Ltd
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The goal of this clinical trial is to test the ATH-063 drug (single and multiple doses) in
Healthy Subjects. The clinical trial aims to evaluate the below.

1. Safety of the drug

2. Tolerability of the drug

3. Pharmacokinetics (PK) (how the human body affects the drug)

4. Pharmacodynamics (PD) (how the drug affects the human body)

This will be a single center, Phase 1, First-In-Human, Randomized, Double-Blind (neither the
subjects nor the experimenters know which subjects are in the test and control groups),
Placebo (a look-alike substance that contains no active drug) - Controlled Study.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05807971
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Nicholas Farinola, B.Sc (Biomed. Sci.),BMBS,FRACP
Address 0 0
CMAX Clinical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries