Healthy VolunteersPhase 1NCT06088784
A Study Assessing the Safety of Oral ATH-399A in Healthy Adult Participants
A Phase 1 study testing ATH-399A, ATH-399A 10 mg and 5 mg ATH-399A capsule in people with Healthy Volunteers, run by HanAll BioPharma Co., Ltd. at 1 site in Canada.
Trial summary
This study will evaluate the safety, tolerability and pharmacokinetics of single and multiple doses of ATH-399A in healthy adults and also evaluate the effect of food on ATH-399A in order to develop mechanism-based and/or disease-modifying treatments for Parkinson Disease. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ATH-399A, ATH-399A 10 mg and 5 mg ATH-399A capsule
- 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 siteCanada
- Study dates
- 19 Sep 2023to 24 Apr 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, as determined by the Investigator based on a medical evaluation including medical history, physical examination, neurological examination, laboratory tests, and cardiac monitoring.
- Population
- Part 1a and 1b: Men and women, age 18-55 years inclusive at the date of screening.
- Part 2: Men and women aged 18-55 years inclusive at the date of screening. Additional cohort: Participants of the additional cohort will be of approximately equal numbers of male and post-menopausal or surgically sterile females, with a minimum of 2 of each gender, aged >55-80 years, inclusive.
- Women of childbearing potential (WOCBP) must be non-pregnant and non-lactating.
- Postmenopausal women must have had ≥12 months of spontaneous amenorrhea (with follicle-stimulating hormone [FSH] ≥40 milli-international units per milliliter (mIU/mL)).
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- Surgically sterile women are defined as those who have had a hysterectomy and/or bilateral oophorectomy. Women who are surgically sterile must provide verbal confirmation.
- Male participants who are sexually active with WOCBP must:
- Agree to use condoms to protect their partners from becoming pregnant during the study (including washout periods) and not to donate sperm for at least 90 days after the last dose of the study drug, and
- Agree to ensure that they and their partners are routinely using a medically approved contraceptive method. It is important that male participants not impregnate others while in the study.
- Body weight ≥50.0 kilograms (kg) for men and ≥45.0 kg for women and body mass index within the range of 18.0-30.0 kilogram/square meter (kg/m^2) (inclusive).
- Participants participating in Part 1b must be willing and able to consume the entire high-fat, high-calorie breakfast in the designated timeframe.
- Participants must understand the nature of the study, must be willing to participate in the study, and must provide signed and dated written informed consent in accordance with local regulations before the conduct of any study-related procedures.
- Participants must be, in the opinion of the Investigator, able to participate in all scheduled evaluations, likely to complete all required tests, and likely to be compliant.
- Participants must be fluent in English or French.
- Participants must agree not to post any personal medical data related to the study or information related to the study on any website or social media site.
Who cannot join
- A positive urine cotinine, drug screen, or alcohol breath test at screening or Day -1.
- Any history of psychiatric disorders, including substance use disorders, according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria that requires current treatment with psychiatric medications. Participants with mild anxiety or depression which is stable for >6 months are permitted.
- 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.
- A diagnosis of intellectual disability (intellectual developmental disorder) or mental retardation.
- A serious mental illness, dementia, or other neuropsychiatric disorder that would interfere with participation in the trial, or ability to provide informed consent in the opinion of the Investigator.
- Any active suicidal ideation as indicated by the C-SSRS (score of ≥4) or history of suicidal behavior within the 12 months prior to screening.
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- A positive Hepatitis B surface antigen or positive Hepatitis C antibody result at screening.
- A positive test at screening for human immunodeficiency virus (HIV) antigen or antibody or a history of positive test.
- Alanine aminotransferase or aspartate aminotransferase levels greater than 1.2 times the ULN at screening or Day -1.
- Frequently use (>5 per week) any tobacco-containing (e.g., cigar, cigarette or snuff) or nicotine-containing product (e.g., nicotine chewing gum, nicotine plasters, or other product used for smoking cessation) within 30 days prior to the first dose administration. Use of any tobacco- or nicotine-containing product is prohibited within 2 weeks of first dose administration through completion of the in-clinic stay for the SAD (Parts 1a and 1b) and until after the final study visit for the MAD (Part 2).
- 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 = 340 mL of beer 5%, 140 mL of wine 12%, or 45 mL of distilled alcohol 40%).
- Regularly consumed (e.g., more days than not) excessive quantities of xanthine-containing beverages (e.g., more than 2 cups of coffee or the equivalent per day) within 1 week prior to screening or between screening and first dose administration, or unwillingness to refrain from xanthine-containing beverages during the in-clinic stay.
- Received or used an investigational product (including placebo) or device within the following time period prior to the first dosing day in the current study: 30 days or 5 half-lives (whichever is longer). For biological products, administration of a biological product within 90 days prior to the first dosing, or concomitant participation in an investigational study involving no drug or device administration.
- Other than those medications outlined in the protocol body and those allowed in the MAD additional cohort, use of prescription or non-prescription drugs, herbal, and dietary supplements (including St John's Wort) within 7 days (or 28 days if the drug is a potential hepatic enzyme inducer) or 5 half-lives (whichever is longer) prior to first dose administration, unless in the opinion of the Investigator and Medical Monitor, the medication will not interfere with the study procedures or compromise participant safety.
- History of clinically significant sensitivity to any of the study drugs, or components thereof, or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates their participation.
- Donation of plasma within 7 days prior to the first dosing or donation or loss of 500 mL or more of whole blood within 8 weeks prior to the first dosing.
- A positive pregnancy test or lactation.
- A history or presence of any disease, condition, or surgery likely to affect drug absorption, distribution, metabolism, or excretion. Participants with a history of cholecystectomy should be excluded.
- A history or presence of a clinically significant hepatic, renal, gastrointestinal, cardiovascular, endocrine, pulmonary, ophthalmologic, immunologic, hematologic, dermatologic, or neurologic abnormality. Participants with fully resolved childhood asthma with no hospitalizations or recurrence in adulthood are permitted to enroll. For the additional cohort in Part 2, any of the above is acceptable where the condition is stable for >6 months and, in the opinion of the Investigator, it does not impact participant safety.
- A clinically significant abnormality on physical examination, neurological examination, electrocardiogram (ECG), or laboratory evaluations at screening and Day -1.
- A QT interval measurement corrected according to the Fridericia rule (QTcF) > 450 milliseconds (msec) during controlled rest at screening and Day -1, or family history of long QT syndrome.
- Any clinically significant abnormalities in rhythm, conduction, or morphology of the resting ECG and any abnormalities in the 12-lead ECG that, in the judgment of the Investigator or Medical Monitor, may interfere with the interpretation of QTc interval changes, including abnormal ST-T-wave morphology or left ventricular hypertrophy.
- A clinically significant vital sign abnormality at screening or between screening and first dose administration.
- Significant (> 10%) weight loss or gain within 30 days prior to screening or between screening and first dose administration.
- A history of seizures. The occurrence of a single febrile seizure is not exclusionary.
- A history of head trauma, including closed head injury with loss of consciousness. Concussions which did not lead to hospitalization or loss of consciousness, and for which there are no ongoing issues, are not exclusionary.
- A history of symptomatic orthostatic hypotension (i.e., postural syncope).
- A history of neuroleptic malignant syndrome.
- A history of chronic urinary tract infections (≥2 times per year).
- The participant is, in the opinion of the Investigator or Medical Monitor, unlikely to comply with the protocol or is unsuitable for any reason.
- Currently employed by NurrOn Pharmaceuticals, Inc., HanAll Biopharma Co. Ltd., or HanAll Pharmaceutical Inc., or by a clinical trial site participating in this study, or a first-degree relative of a NurrOn Pharmaceuticals, Inc. or HanAll Pharmaceutical Inc., or HanAll Biopharma Co. Ltd. employee or of an employee at a participating clinical trial site.
- Unsatisfactory venous access.
- Unable to swallow oral capsules.
- Positive result to a coronavirus disease (COVID-19) Polymerase chain reaction (PCR) test.
- COVID-19 or flu vaccination within 30 days prior to study drug administration or any other vaccination that is judged by the investigator to potentially affect eligibility.
- Presence of fever (body temperature >37.5°C) (e.g., a fever associated with a symptomatic viral or bacterial infection) within 2 weeks prior to the first dosing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics of Single and Multiple Doses as Well as the Food Effect of Orally Administered ATH-399A in Healthy Adult Participants
This study will evaluate the safety, tolerability and pharmacokinetics of single and multiple doses of ATH-399A in healthy adults and also evaluate the effect of food on ATH-399A in order to develop mechanism-based and/or disease-modifying treatments for Parkinson Disease.
- Conditions
- Healthy Volunteers
- Being tested
- ATH-399A, Placebo, ATH-399A 10 mg, 5 mg ATH-399A capsule, 20mg ATH-399A capsule
- Keywords
- ATH399A, HL192, Parkinson's Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATH-399ADrug
Also called ATH-399A, HL192
Orally administered drug in capsule form.
PlaceboDrug
Orally administered drug in capsule form.
ATH-399A 10 mgDrug
Participants will receive single oral dose of 10 mg of ATH-399A capsule
5 mg ATH-399A capsuleDrug
Participants will receive single oral dose of 5mg of ATH-399A capsule
20mg ATH-399A capsuleDrug
Participants will receive single oral dose of 20mg of ATH-399A capsule
40mg ATH-399A capsuleDrug
Participants will receive single oral dose of 40mg of ATH-399A capsule
80mg ATH-399A capsuleDrug
Participants will receive single oral dose of 80mg of ATH-399A capsule
| Study group | Role | What they receive |
|---|---|---|
| Part 1a (Single Ascending Doses (SAD)): ATH-399A | Experimental | Participants will receive single oral dose of ATH-399A capsule at 5mg, 10mg, 20mg, 40mg, 80mg. Receives: Drug: ATH-399A |
| Part 1a (SAD): Placebo | Placebo comparator | Participants will receive single oral dose of placebo-matched to ATH-399A capsule. Receives: Drug: Placebo |
| Part 1b (High calorie): ATH-399A | Experimental | Participants will receive single oral dose of ATH-399A capsule after high-calorie, high-fat breakfast and then will cross over to receive single oral dose of ATH-399A capsule after fasting. Receives: Drug: ATH-399A |
| Part 1b (Fasting): ATH-399A | Experimental | Participants will receive single oral dose of ATH-399A capsule after fasting and then will cross over to receive single oral dose of ATH-399A capsule after high-calorie, high-fat breakfast. Receives: Drug: ATH-399A |
| Part 2 (Multiple Ascending doses (MAD)): ATH-399A | Experimental | Participants will receive once daily (QD) dose of ATH-399A capsules from Day 1 to Day 12 in fasted state. Receives: Drug: ATH-399A |
| Part 2 (MAD): Placebo | Placebo comparator | Participants will receive QD dose of placebo-matched to ATH-399A capsules from Day 1 to Day 12 in fasted state. Receives: Drug: Placebo |
| Additional Cohort (Ages 56-80 years old): ATH-399A | Experimental | Participants will receive QD dose of ATH-399A capsules from Day 1 to Day 12 in fasted state following MAD dosing. Receives: Drug: ATH-399A |
| Additional Cohort: (Ages 56-80 years old) Placebo | Placebo comparator | Participants will receive QD dose of placebo-matched to ATH-399A capsules from Day 1 to Day 12 in fasted state following MAD dosing. Receives: Drug: Placebo |
| Part 1a - ATH-399A 20 mg | Experimental | Participants will receive single oral dose of 20mg of ATH-399A capsule Receives: Drug: 20mg ATH-399A capsule |
| Part 1a (Single Ascending Doses (SAD)): ATH-399A 10 mg | Experimental | Participants will receive single oral dose of 10mg of ATH-399A capsule Receives: Drug: ATH-399A 10 mg |
| Part 1a (Single Ascending Doses (SAD)): ATH-399A 5 mg | Experimental | Participants will receive single oral dose of 5mg of ATH-399A capsule Receives: Drug: 5 mg ATH-399A capsule |
| Part 1a (Single Ascending Doses (SAD)): ATH-399A 40 mg | Experimental | Participants will receive single oral dose of 40mg of ATH-399A capsule Receives: Drug: 40mg ATH-399A capsule |
| Part 1a (Single Ascending Doses (SAD)): ATH-399A 80 mg | Experimental | Participants will receive single oral dose of 80mg of ATH-399A capsule Receives: Drug: 80mg ATH-399A capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of TEAEs
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
Measured: Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
Participants With at Least 1 TEAE
Participants with at least one AE started or after the time of first study drug administration.
Measured: Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
Serious TEAEs
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the criteria listed: Resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or other situations.
Measured: Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
Suicidal Ideation and/or Behavior Detected in Columbia Suicidality Severity Rating Scale (C-SSRS)
Number of participant whose answers indicate suicidal ideation and/or behavior at follow-up.
Measured: Part 1a, 1b: Screening, Day -1, Follow-up (1a - Day 16; 1b - Day 19); Part 2: Screening, Day -1, Day 13 (Discharge or early termination)
QTcF Analysis
Participants with abnormal QTcF on ECG (pooled data from the whole study duration)
Measured: From baseline to follow up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
Changes in Diastolic Blood Pressure
Diastolic blood pressure baseline value measured at basline Day 1 pre dose and Day 1 1 hour post dosing
Measured: Day 1: predose and 1 hour post dosing
Changes in Systolic Blood Pressure
Systolic blood pressure baseline value measured at basline Day 1 pre dose and Day 1 1 hour post dosing
Measured: Day 1 predose and 1 hour postdosing
Heart Rate Value
Heart rate value measured at Day 1, 1 Hour Post-Dose
Measured: Day 1, 1 hour post-dose
Temperature Value
Temperature value measured at Day 1, 1 Hour Post-Dose
Measured: Day 1, 1 Hour Post-Dose
Respiratory Rate Value
Respiratory rate value measured at Day 1, 1 Hour Post-Dose
Measured: Day 1, 1 Hour Post-Dose
Physical Examination and Neurological Examination Abnormalities Analysis
Participants with abnormal findings on physical and neurological examination (pooled data from the whole study)
Measured: Part 1a, 1b, 2: Screening, D-1, D3 (Discharge or early termination), Follow-Up: Part 1a: Day 8, Part 1b: Day 16; and Part 2: Day 19
12-Lead Telemetry Abnormalities Analysis
Participants with abnormal findings on 12-lead telemetry (pooled data from the whole study)
Measured: Part 1a, 1b: D1, D2, D3; Part 2: D1, D2, D12, D13 (Discharge or early termination)
Laboratory Parameter: Creatinine Value
Laboratory parameter: Creatinine level on Day 1
Measured: Day 1
Laboratory Parameter: Glucose
Laboratory parameter: Glucose level measured on Day 1
Measured: Day 1
Secondary outcomes (12)
AUC0-t
Plasma Pharmacokinetic (PK) parameter: Area Under the Concentration-Time Curve from Time Zero Until the Last Observed Concentration (AUC0-t) for Part 1a, Part 1b and Part 2. AUC0-t was calculated based on several PK blood sampling at times provided in the Outcome Measure Time Frame.
Measured: Part 1: Day 1 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours. Part 2: Day 12 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours.
AUC0-inf
PK parameter: Area Under The Concentration-Time Curve From Time Zero To Infinity (Extrapolated) (AUC0-inf) for Part 1a, Part 1b and Part 2. AUC0-inf was calculated based on several PK blood sampling at times provided in the Outcome Measure Time Frame.
Measured: Part 1: Day 1 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours. Part 2: Day 12 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours.
Cmax
PK parameter: Maximal Observed Concentration (Cmax) for Part 1a, Part 1b and Part 2. Cmax was calculated based on several PK blood sampling at times provided in the Outcome Measure Time Frame.
Measured: Part 1: Day 1 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours. Part 2: Day 1 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours.
Tmax
PK parameter: Time When The Maximal Concentration Is Observed (Tmax) for Part 1a, Part 1b and Part 2. Tmax was calculated based on several PK blood sampling at times provided in the Outcome Measure Time Frame.
Measured: Part 1: Day 1 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours. Part 2: Day 1 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours.
λz
PK parameter: Individual Estimate Of The Terminal Elimination Rate Constant (λz) for Part 1a, Part 1b and Part 2. λz was calculated based on several PK blood sampling at times provided in the Outcome Measure Time Frame.
Measured: Part 1: Day 1 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours. Part 2: Day 12 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours.
t½ el
PK parameter: Terminal Elimination Half-Life (t½ el) for Part 1a, Part 1b and Part 2. T1/2 el was calculated based on several PK blood sampling at times provided in the Outcome Measure Time Frame.
Measured: Part 1: Day 1 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours. Part 2: Day 12 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours.
Cmax, ss
PK parameter: Maximal Observed Concentration at steady state (Cmax, ss) for Part 2. Cmax,ss was calculated based on several PK blood sampling at times provided in the Outcome Measure Time Frame.
Measured: Part 2 only: Day 12 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours.
Cmin ss
PK parameter: Minimal Observed Concentration at steady-state (Cmin ss) for Part 2. Cmin was calculated based on several PK blood sampling at times provided in the Outcome Measure Time Frame.
Measured: Part 2 only: Day 12 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours
Cavg
PK parameter: Average Plasma Concentration (Cavg) for Part 2. Cavg was calculated based on several PK blood sampling at times provided in the Outcome Measure Time Frame.
Measured: Part 2 only: Day 12 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours.
Tmax, ss
PK parameter: Time When The Maximal Concentration Is Observed at Steady State (Tmax, ss) for Part 2. Tmax, ss was calculated based on several PK blood sampling at times provided in the Outcome Measure Time Frame.
Measured: Part 2 only: Day 12 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours.
AUC0-τ (AUC0-24 at Day 12 Dose) for Part 2
PK parameter: Area Under The Concentration-Time Curve For One Dosing Interval (Τ) (AUC0-τ) [i.e., AUC0-24 on Day 12 dose] for Part 2 only. Value was calculated based on several PK blood sampling at times provided in the Outcome Measure Time Frame.
Measured: Part 2 only: Day 12 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours.
AUC0-t on Day 1 Dose for Part 2
PK parameter: Area Under The Concentration-Time Curve AUC0-t (i.e., AUC0-24 on Day 1 dose only) for Part 2
Measured: Part 2 only: Day 1 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start19 Sep 2023
- Primary completion24 Apr 2024
- Study completion24 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy VolunteersStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- HanAll BioPharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NurrOn Pharmaceuticals, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06088784
- Sponsor's protocol ID
- HL192-PD-CA-P101
- Other IDs
- 230119
- Status last verified
- Dec 2025
- First submitted
- 5 Oct 2023
- Last updated
- 19 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics of Single and Multiple Doses as Well as the Food Effect of Orally Administered ATH-399A in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06088784
- Acronym / sponsor ID
- HL192-PD-CA-P101
- Conditions
- Healthy Volunteers
- Keywords
- ATH399A, HL192, Parkinson's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- HanAll BioPharma Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- NurrOn Pharmaceuticals, Inc.
- Study start
- 19 Sep 2023 (actual)
- Primary completion
- 24 Apr 2024 (actual)
- Study completion
- 24 Apr 2024 (actual)
- First posted
- 18 Oct 2023 (actual)
- Results
- Posted 19 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety, tolerability and pharmacokinetics of single and multiple doses of ATH-399A in healthy adults and also evaluate the effect of food on ATH-399A in order to develop mechanism-based and/or disease-modifying treatments for Parkinson Disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| Part 1a (Single Ascending Doses (SAD)): ATH-399A | Experimental | Drug: ATH-399AParticipants will receive single oral dose of ATH-399A capsule at 5mg, 10mg, 20mg, 40mg, 80mg. |
| Part 1a (SAD): Placebo | Placebo comparator | Drug: PlaceboParticipants will receive single oral dose of placebo-matched to ATH-399A capsule. |
| Part 1b (High calorie): ATH-399A | Experimental | Drug: ATH-399AParticipants will receive single oral dose of ATH-399A capsule after high-calorie, high-fat breakfast and then will cross over to receive single oral dose of ATH-399A capsule after fasting. |
| Part 1b (Fasting): ATH-399A | Experimental | Drug: ATH-399AParticipants will receive single oral dose of ATH-399A capsule after fasting and then will cross over to receive single oral dose of ATH-399A capsule after high-calorie, high-fat breakfast. |
| Part 2 (Multiple Ascending doses (MAD)): ATH-399A | Experimental | Drug: ATH-399AParticipants will receive once daily (QD) dose of ATH-399A capsules from Day 1 to Day 12 in fasted state. |
| Part 2 (MAD): Placebo | Placebo comparator | Drug: PlaceboParticipants will receive QD dose of placebo-matched to ATH-399A capsules from Day 1 to Day 12 in fasted state. |
| Additional Cohort (Ages 56-80 years old): ATH-399A | Experimental | Drug: ATH-399AParticipants will receive QD dose of ATH-399A capsules from Day 1 to Day 12 in fasted state following MAD dosing. |
| Additional Cohort: (Ages 56-80 years old) Placebo | Placebo comparator | Drug: PlaceboParticipants will receive QD dose of placebo-matched to ATH-399A capsules from Day 1 to Day 12 in fasted state following MAD dosing. |
| Part 1a - ATH-399A 20 mg | Experimental | Drug: 20mg ATH-399A capsuleParticipants will receive single oral dose of 20mg of ATH-399A capsule |
| Part 1a (Single Ascending Doses (SAD)): ATH-399A 10 mg | Experimental | Drug: ATH-399A 10 mgParticipants will receive single oral dose of 10mg of ATH-399A capsule |
| Part 1a (Single Ascending Doses (SAD)): ATH-399A 5 mg | Experimental | Drug: 5 mg ATH-399A capsuleParticipants will receive single oral dose of 5mg of ATH-399A capsule |
| Part 1a (Single Ascending Doses (SAD)): ATH-399A 40 mg | Experimental | Drug: 40mg ATH-399A capsuleParticipants will receive single oral dose of 40mg of ATH-399A capsule |
| Part 1a (Single Ascending Doses (SAD)): ATH-399A 80 mg | Experimental | Drug: 80mg ATH-399A capsuleParticipants will receive single oral dose of 80mg of ATH-399A capsule |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Healthy, as determined by the Investigator based on a medical evaluation including medical history, physical examination, neurological examination, laboratory tests, and cardiac monitoring.
- Population
- Women of childbearing potential (WOCBP) must be non-pregnant and non-lactating.
- Postmenopausal women must have had ≥12 months of spontaneous amenorrhea (with follicle-stimulating hormone [FSH] ≥40 milli-international units per milliliter (mIU/mL)).
- Surgically sterile women are defined as those who have had a hysterectomy and/or bilateral oophorectomy. Women who are surgically sterile must provide verbal confirmation.
Key exclusion criteria (36 listed)
- A positive urine cotinine, drug screen, or alcohol breath test at screening or Day -1.
- Any history of psychiatric disorders, including substance use disorders, according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria that requires current treatment with psychiatric medications. Participants with mild anxiety or depression which is stable for >6 months are permitted.
- 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.
- A diagnosis of intellectual disability (intellectual developmental disorder) or mental retardation.
- A serious mental illness, dementia, or other neuropsychiatric disorder that would interfere with participation in the trial, or ability to provide informed consent in the opinion of the Investigator.
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-399AAlso: ATH-399A, HL192Orally administered drug in capsule form. | Drug | Additional Cohort (Ages 56-80 years old): ATH-399A, Part 1a (Single Ascending Doses (SAD)): ATH-399A, Part 1b (Fasting): ATH-399A, Part 1b (High calorie): ATH-399A, Part 2 (Multiple Ascending doses (MAD)): ATH-399A |
| PlaceboOrally administered drug in capsule form. | Drug | Additional Cohort: (Ages 56-80 years old) Placebo, Part 1a (SAD): Placebo, Part 2 (MAD): Placebo |
| ATH-399A 10 mgParticipants will receive single oral dose of 10 mg of ATH-399A capsule | Drug | Part 1a (Single Ascending Doses (SAD)): ATH-399A 10 mg |
| 5 mg ATH-399A capsuleParticipants will receive single oral dose of 5mg of ATH-399A capsule | Drug | Part 1a (Single Ascending Doses (SAD)): ATH-399A 5 mg |
| 20mg ATH-399A capsuleParticipants will receive single oral dose of 20mg of ATH-399A capsule | Drug | Part 1a - ATH-399A 20 mg |
| 40mg ATH-399A capsuleParticipants will receive single oral dose of 40mg of ATH-399A capsule | Drug | Part 1a (Single Ascending Doses (SAD)): ATH-399A 40 mg |
| 80mg ATH-399A capsuleParticipants will receive single oral dose of 80mg of ATH-399A capsule | Drug | Part 1a (Single Ascending Doses (SAD)): ATH-399A 80 mg |
Primary outcome
Number of TEAEs
Time frame: Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
Participants With at Least 1 TEAE
Time frame: Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
Participants with at least one AE started or after the time of first study drug administration.
Serious TEAEs
Time frame: Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the criteria listed: Resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or other situations.
Suicidal Ideation and/or Behavior Detected in Columbia Suicidality Severity Rating Scale (C-SSRS)
Time frame: Part 1a, 1b: Screening, Day -1, Follow-up (1a - Day 16; 1b - Day 19); Part 2: Screening, Day -1, Day 13 (Discharge or early termination)
Number of participant whose answers indicate suicidal ideation and/or behavior at follow-up.
QTcF Analysis
Time frame: From baseline to follow up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
Participants with abnormal QTcF on ECG (pooled data from the whole study duration)
Changes in Diastolic Blood Pressure
Time frame: Day 1: predose and 1 hour post dosing
Diastolic blood pressure baseline value measured at basline Day 1 pre dose and Day 1 1 hour post dosing
Changes in Systolic Blood Pressure
Time frame: Day 1 predose and 1 hour postdosing
Systolic blood pressure baseline value measured at basline Day 1 pre dose and Day 1 1 hour post dosing
Heart Rate Value
Time frame: Day 1, 1 hour post-dose
Heart rate value measured at Day 1, 1 Hour Post-Dose
Temperature Value
Time frame: Day 1, 1 Hour Post-Dose
Temperature value measured at Day 1, 1 Hour Post-Dose
Respiratory Rate Value
Time frame: Day 1, 1 Hour Post-Dose
Respiratory rate value measured at Day 1, 1 Hour Post-Dose
Physical Examination and Neurological Examination Abnormalities Analysis
Time frame: Part 1a, 1b, 2: Screening, D-1, D3 (Discharge or early termination), Follow-Up: Part 1a: Day 8, Part 1b: Day 16; and Part 2: Day 19
Participants with abnormal findings on physical and neurological examination (pooled data from the whole study)
12-Lead Telemetry Abnormalities Analysis
Time frame: Part 1a, 1b: D1, D2, D3; Part 2: D1, D2, D12, D13 (Discharge or early termination)
Participants with abnormal findings on 12-lead telemetry (pooled data from the whole study)
Laboratory Parameter: Creatinine Value
Time frame: Day 1
Laboratory parameter: Creatinine level on Day 1
Laboratory Parameter: Glucose
Time frame: Day 1
Laboratory parameter: Glucose level measured on Day 1
12 secondary outcomes
AUC0-t
Time frame: Part 1: Day 1 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours. Part 2: Day 12 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours.
AUC0-inf
Time frame: Part 1: Day 1 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours. Part 2: Day 12 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours.
Cmax
Time frame: Part 1: Day 1 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours. Part 2: Day 1 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours.
Tmax
Time frame: Part 1: Day 1 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours. Part 2: Day 1 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours.
λz
Time frame: Part 1: Day 1 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours. Part 2: Day 12 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours.
t½ el
Time frame: Part 1: Day 1 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours. Part 2: Day 12 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours.
Cmax, ss
Time frame: Part 2 only: Day 12 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours.
Cmin ss
Time frame: Part 2 only: Day 12 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours
Cavg
Time frame: Part 2 only: Day 12 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours.
Tmax, ss
Time frame: Part 2 only: Day 12 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours.
AUC0-τ (AUC0-24 at Day 12 Dose) for Part 2
Time frame: Part 2 only: Day 12 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours.
AUC0-t on Day 1 Dose for Part 2
Time frame: Part 2 only: Day 1 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
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-399A, ATH-399A 10 mg and 5 mg ATH-399A capsule in people with Healthy Volunteers, run by HanAll BioPharma Co., Ltd. at 1 site in Canada.
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 16 inclusion and 36 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 19 Dec 2025. 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 Canada. 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?
Yes. Results are posted in the registry (first posted 19 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of TEAEs (time frame: Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19). The study lists 14 primary outcomes in all. 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 19 Dec 2025.