Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ATH-063 in Healthy Subjects

NCT05807971 | Completed Phase 1 DMC

• 1 other identifier: ATH-001
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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. 1.Safety of the drug
2. 2.Tolerability of the drug
3. 3.Pharmacokinetics (PK) (how the human body affects the drug)
4. 4.Pharmacodynamics (PD) (how the drug affects the human body)

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis; Autoimmune Diseases

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety and tolerability of ATH-063 following oral administration of single and multiple ascending doses in healthy participants.

  Number of participants with serious and other non-serious adverse events

  SAD: Up to 15 ± 1 day, MAD: Up to 24 ± 1 day, FE: Up to 14 ± 1 day

Secondary Outcomes (17)

• Pharmacokinetic assessment 1

  SAD: Up to 15 ± 1 day, MAD: Up to 24 ± 1 day, FE: Up to 14 ± 1 day

• Pharmacokinetic assessment 2

  SAD: Up to 15 ± 1 day, MAD: Up to 24 ± 1 day, FE: Up to 14 ± 1 day

• Pharmacokinetic assessment 3

  SAD: Up to 15 ± 1 day, MAD: Up to 24 ± 1 day, FE: Up to 14 ± 1 day

• Pharmacokinetic assessment 4

  SAD: Up to 15 ± 1 day, MAD: Up to 24 ± 1 day, FE: Up to 14 ± 1 day

• Pharmacokinetic assessment 5

  SAD: Up to 15 ± 1 day, MAD: Up to 24 ± 1 day, FE: Up to 14 ± 1 day

Other Outcomes (4)

• Pharmacodynamic assessment 1

  MAD: Up to 24 ± 1 day

• Pharmacodynamic assessment 2

  MAD: Up to 24 ± 1 day

• Pharmacodynamic assessment 3

  MAD: Up to 24 ± 1 day

Study Arms (5)

SAD cohort

EXPERIMENTAL

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.

Drug: ATH-063

MAD Cohort

EXPERIMENTAL

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.

Drug: ATH-063

Food Effect

EXPERIMENTAL

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.

Drug: ATH-063

SAD cohort (Placebo)

PLACEBO COMPARATOR

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.

Drug: Placebo

MAD cohort (Placebo)

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

ATH-063 DRUG

12.5 and 50 mg Capsules, anticipated dose range to be from 25 to 250 mg.

Food Effect; MAD Cohort; SAD cohort

Placebo DRUG

Identical capsule to the drug without the active ingredient.

MAD cohort (Placebo); SAD cohort (Placebo)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Healthy as defined by:
• the absence of clinically significant illness and surgery within 4 weeks prior to study drug administration.
• 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.
• Female participants of non-childbearing potential must be:
• 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
• surgically sterile (bilateral oophorectomy, bilateral salpingectomy, hysterectomy, or tubal ligation) at least 3 months prior to dosing.
• 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.
• Able to understand the study procedures and provide signed informed consent to participate in the study.

You may not qualify if:

• Any clinically significant abnormal finding at physical examination.
• Clinically significant abnormal laboratory test results or positive serology test results for HBsAg, HCV antibody, or HIV antigen and antibody, at screening.
• Positive pregnancy test or lactating female subject
• Positive urine drug screen, urine cotinine test, or alcohol breath test (one repeat is allowed).
• History of significant allergic reactions (e.g., anaphylactic reaction, hypersensitivity, angioedema) to any drug.
• 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.
• 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.
• 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.
• 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):
• depot injection or implant within 3 months prior to the first dosing;
• live attenuated vaccines within 1 month prior to the first dosing;
• any drug known to induce or inhibit hepatic drug metabolism, including St. John's wort, within 30 days prior to the first dosing;
• prescription medications within 14 days prior to the first dosing;
• any other vaccine, including COVID-19 vaccine, within 14 days prior to the first dosing;
• 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).

Sponsors & Collaborators

• Athos Therapeutics Inc: lead
• Syneos Health: collaborator
• Athos Therapeutics Australia Pty Ltd: collaborator

Study Sites (1)

CMAX Clinical Research

Adelaide, South Australia, 5000, Australia

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Immune System Diseases

Study Officials

• Nicholas Farinola, B.Sc (Biomed. Sci.),BMBS,FRACP

  CMAX Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study will be double-blinded. The subjects and the clinical personnel involved in the collection, monitoring, revision, or evaluation of AEs, or personnel who could have an impact on the outcome of the study will be blinded with respect to the subject's treatment assignment (ATH-063 or placebo).
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Cohorts (4 each) within the SAD and MAD part will be dosed sequentially in an ascending fashion. MAD cohorts and FE cohort will be dosed in parallel after the completion of the SAD Cohorts.

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 11, 2023
• Study Start: April 6, 2023
• Primary Completion: February 8, 2024
• Study Completion: February 8, 2024
• Last Updated: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)