Inflammatory Bowel DiseasesPhase 1NCT05807971
Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ATH-063 in Healthy Subjects
A Phase 1 study testing ATH-063 in people with Inflammatory Bowel Diseases and Crohn Disease, run by Athos Therapeutics Inc at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
- What is being tested?
- ATH-063
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteAustralia
- Study dates
- 6 Apr 2023to 8 Feb 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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).
- 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.
- 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.
- Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Safety of the drug
- Tolerability of the drug
- Pharmacokinetics (PK) (how the human body affects the drug)
- 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.
Read the detailed description
Primary Objective of this study will be to evaluate the safety and tolerability of ATH-063 following oral administration of single and multiple ascending doses (SAD/MAD) in healthy subjects.
This is a single center, Phase 1, Randomized, Double-blind, Placebo controlled, sequential SAD/MAD study, with a food-effect arm. The study will be divided into three parts:
- SAD cohorts
- MAD cohorts
- Food-effect (FE) cohort
MAD and FE cohorts will be dosed in parallel after the completion of the SAD Cohorts
SAD Part:
- Consist of at least 4 cohorts (1 cohort per dose level).
- Each cohort will include approximately 8 participants (6 participants receiving the active and 2 participants receiving the placebo).
- A staggered dosing schedule will be used for dosing of each cohort (under fasting conditions)
MAD Part:
- Consist of up to 4 cohorts (1 cohort per dose level).
- Each cohort will include approximately 8 participants (6 participants receiving the active and 2 participants receiving the placebo).
- The cohorts will be dosed sequentially in an ascending fashion.
- The dose of MAD cohorts is dependent on the available safety, tolerability, and PK data from the SAD part and available safety, tolerability, and PK data from dosed MAD cohorts.
Food-effect Part:
- Approximately twelve (12) participants will be randomized in a 1:1 ratio to one of two treatment sequences (fast-fed/fed-fast) with 6 participants per treatment sequence.
- The selection of the dose to be administered in the food effect part will depend on the results of the SAD part following the review of safety, tolerability and PK data of the SAD cohorts.
- Being tested
- ATH-063, Placebo
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATH-063Drug
12.5 and 50 mg Capsules, anticipated dose range to be from 25 to 250 mg.
PlaceboDrug
Identical capsule to the drug without the active ingredient.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: SAD: Up to 15 ± 1 day, MAD: Up to 24 ± 1 day, FE: Up to 14 ± 1 day
Secondary outcomes (17)
Pharmacokinetic assessment 1
AUC0-t (Area under the plasma concentration-time curve)
Measured: SAD: Up to 15 ± 1 day, MAD: Up to 24 ± 1 day, FE: Up to 14 ± 1 day
Pharmacokinetic assessment 2
AUC0-inf (AUC curve to infinite time)
Measured: SAD: Up to 15 ± 1 day, MAD: Up to 24 ± 1 day, FE: Up to 14 ± 1 day
Pharmacokinetic assessment 3
Cmax (Maximum plasma concentration)
Measured: SAD: Up to 15 ± 1 day, MAD: Up to 24 ± 1 day, FE: Up to 14 ± 1 day
Pharmacokinetic assessment 4
Tmax (Time to maximum plasma concentration (Cmax)
Measured: SAD: Up to 15 ± 1 day, MAD: Up to 24 ± 1 day, FE: Up to 14 ± 1 day
Pharmacokinetic assessment 5
Residual area
Measured: SAD: Up to 15 ± 1 day, MAD: Up to 24 ± 1 day, FE: Up to 14 ± 1 day
Pharmacokinetic assessment 6
T½ el (Half Life)
Measured: SAD: Up to 15 ± 1 day, MAD: Up to 24 ± 1 day, FE: Up to 14 ± 1 day
Pharmacokinetic assessment 7
Kel (Elimination rate constant)
Measured: SAD: Up to 15 ± 1 day, MAD: Up to 24 ± 1 day, FE: Up to 14 ± 1 day
Pharmacokinetic assessment 8
Cl/F (Oral Clearance)
Measured: SAD: Up to 15 ± 1 day, FE: Up to 14 ± 1 day
Pharmacokinetic assessment 9
Clss/F (Oral Clearance-steady state)
Measured: MAD: Up to 24 ± 1 day
Pharmacokinetic assessment 10
Vz/F (Apparent volume of distribution)
Measured: SAD: Up to 15 ± 1 day, FE: Up to 14 ± 1 day
Pharmacokinetic assessment 11
AUC0-24 (area under the plasma concentration-time curve over the last 24-h dosing interval)
Measured: MAD: Up to 24 ± 1 day
Pharmacokinetic assessment 12
AUC0-tau (area under the curve to the end of the dosing period)
Measured: MAD: Up to 24 ± 1 day
Pharmacokinetic assessment 13
Cmax ss (Maximum plasma concentration at steady state)
Measured: MAD: Up to 24 ± 1 day
Pharmacokinetic assessment 14
Tmax ss (Time to steady state Cmax)
Measured: MAD: Up to 24 ± 1 day
Pharmacokinetic assessment 15
Cmin ss (Minimum drug concentration at steady-state)
Measured: MAD: Up to 24 ± 1 day
Pharmacokinetic assessment 16
Vz ss/F (Apparent volume of distribution at steady state)
Measured: MAD: Up to 24 ± 1 day
Pharmacokinetic assessment 17
Tlag (Lag time)
Measured: FE: Up to 14 ± 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start6 Apr 2023
- Primary completion8 Feb 2024
- Study completion8 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Athos Therapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health, Athos Therapeutics Australia Pty Ltd
- Responsible party
- Sponsor
- Investigators
- Nicholas Farinola, B.Sc (Biomed. Sci.),BMBS,FRACP, Principal investigator, CMAX Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05807971
- Sponsor's protocol ID
- ATH-001
- Status last verified
- May 2024
- First submitted
- 29 Mar 2023
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05807971
- Acronym / sponsor ID
- ATH-001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Athos Therapeutics IncIndustry (pharma, biotech, devices)
- Collaborators
- Syneos Health, Athos Therapeutics Australia Pty Ltd
- Study start
- 6 Apr 2023 (actual)
- Primary completion
- 8 Feb 2024 (actual)
- Study completion
- 8 Feb 2024 (actual)
- First posted
- 11 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Safety of the drug
- Tolerability of the drug
- Pharmacokinetics (PK) (how the human body affects the drug)
- 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.
Detailed description
Primary Objective of this study will be to evaluate the safety and tolerability of ATH-063 following oral administration of single and multiple ascending doses (SAD/MAD) in healthy subjects.
This is a single center, Phase 1, Randomized, Double-blind, Placebo controlled, sequential SAD/MAD study, with a food-effect arm. The study will be divided into three parts:
- SAD cohorts
- MAD cohorts
- Food-effect (FE) cohort
MAD and FE cohorts will be dosed in parallel after the completion of the SAD Cohorts
SAD Part:
- Consist of at least 4 cohorts (1 cohort per dose level).
- Each cohort will include approximately 8 participants (6 participants receiving the active and 2 participants receiving the placebo).
- A staggered dosing schedule will be used for dosing of each cohort (under fasting conditions)
MAD Part:
- Consist of up to 4 cohorts (1 cohort per dose level).
- Each cohort will include approximately 8 participants (6 participants receiving the active and 2 participants receiving the placebo).
- The cohorts will be dosed sequentially in an ascending fashion.
- The dose of MAD cohorts is dependent on the available safety, tolerability, and PK data from the SAD part and available safety, tolerability, and PK data from dosed MAD cohorts.
Food-effect Part:
- Approximately twelve (12) participants will be randomized in a 1:1 ratio to one of two treatment sequences (fast-fed/fed-fast) with 6 participants per treatment sequence.
- The selection of the dose to be administered in the food effect part will depend on the results of the SAD part following the review of safety, tolerability and PK data of the SAD cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| SAD cohort | Experimental | Drug: ATH-063SAD 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. |
| MAD Cohort | Experimental | Drug: ATH-063MAD 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. |
| Food Effect | Experimental | Drug: ATH-063An 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. |
| SAD cohort (Placebo) | Placebo comparator | Drug: PlaceboSAD 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. |
| MAD cohort (Placebo) | Placebo comparator | Drug: PlaceboMAD 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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:
- Female participants of non-childbearing potential must be:
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATH-06312.5 and 50 mg Capsules, anticipated dose range to be from 25 to 250 mg. | Drug | Food Effect, MAD Cohort, SAD cohort |
| PlaceboIdentical capsule to the drug without the active ingredient. | Drug | MAD cohort (Placebo), SAD cohort (Placebo) |
Primary outcome
To evaluate the safety and tolerability of ATH-063 following oral administration of single and multiple ascending doses in healthy participants.
Time frame: SAD: Up to 15 ± 1 day, MAD: Up to 24 ± 1 day, FE: Up to 14 ± 1 day
Number of participants with serious and other non-serious adverse events
17 secondary outcomes
Pharmacokinetic assessment 1
Time frame: SAD: Up to 15 ± 1 day, MAD: Up to 24 ± 1 day, FE: Up to 14 ± 1 day
Pharmacokinetic assessment 2
Time frame: SAD: Up to 15 ± 1 day, MAD: Up to 24 ± 1 day, FE: Up to 14 ± 1 day
Pharmacokinetic assessment 3
Time frame: SAD: Up to 15 ± 1 day, MAD: Up to 24 ± 1 day, FE: Up to 14 ± 1 day
Pharmacokinetic assessment 4
Time frame: SAD: Up to 15 ± 1 day, MAD: Up to 24 ± 1 day, FE: Up to 14 ± 1 day
Pharmacokinetic assessment 5
Time frame: SAD: Up to 15 ± 1 day, MAD: Up to 24 ± 1 day, FE: Up to 14 ± 1 day
Pharmacokinetic assessment 6
Time frame: SAD: Up to 15 ± 1 day, MAD: Up to 24 ± 1 day, FE: Up to 14 ± 1 day
Pharmacokinetic assessment 7
Time frame: SAD: Up to 15 ± 1 day, MAD: Up to 24 ± 1 day, FE: Up to 14 ± 1 day
Pharmacokinetic assessment 8
Time frame: SAD: Up to 15 ± 1 day, FE: Up to 14 ± 1 day
Pharmacokinetic assessment 9
Time frame: MAD: Up to 24 ± 1 day
Pharmacokinetic assessment 10
Time frame: SAD: Up to 15 ± 1 day, FE: Up to 14 ± 1 day
Pharmacokinetic assessment 11
Time frame: MAD: Up to 24 ± 1 day
Pharmacokinetic assessment 12
Time frame: MAD: Up to 24 ± 1 day
Pharmacokinetic assessment 13
Time frame: MAD: Up to 24 ± 1 day
Pharmacokinetic assessment 14
Time frame: MAD: Up to 24 ± 1 day
Pharmacokinetic assessment 15
Time frame: MAD: Up to 24 ± 1 day
Pharmacokinetic assessment 16
Time frame: MAD: Up to 24 ± 1 day
Pharmacokinetic assessment 17
Time frame: FE: Up to 14 ± 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas Farinola, B.Sc (Biomed. Sci.),BMBS,FRACP principal investigator
CMAX Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ATH-063 in people with Inflammatory Bowel Diseases and Crohn Disease, run by Athos Therapeutics Inc at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability of ATH-063 following oral administration of single and multiple ascending doses in healthy participants. (time frame: SAD: Up to 15 ± 1 day, MAD: Up to 24 ± 1 day, FE: Up to 14 ± 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.