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ATH-399A Safety in Healthy Subjects

Phase 1
Recruiting
Research Sponsored by HanAll BioPharma Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Postmenopausal women must have had ≥12 months of spontaneous amenorrhea (with follicle-stimulating hormone [FSH] ≥40 milli-international units per milliliter (mIU/mL)).
Participants must be fluent in English or French.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 36 hours post-dose
Awards & highlights

Study Summary

This trial will assess the safety and effectiveness of a potential Parkinson's treatment in healthy adults.

Who is the study for?
Adults aged 18-55, and a specific group from 55-80 years old, who are healthy as determined by medical evaluation. Women must be non-pregnant and either postmenopausal or surgically sterile; men must agree to use contraception. Participants should not have any significant medical history that affects drug absorption or processing, no recent blood donations, negative for HIV/Hepatitis B/C, non-smokers, and not on certain medications.Check my eligibility
What is being tested?
The trial is testing the safety of a new oral medication called ATH-399A in healthy adults. It will look at how the body reacts to different doses when taken once or multiple times and see if food affects its action. The goal is to find potential treatments for Parkinson's Disease based on how this drug behaves in the body.See study design
What are the potential side effects?
Since this is an early-stage study focusing on safety and how the body processes ATH-399A, side effects are being closely monitored but may include typical reactions such as nausea, headache, dizziness or allergic responses depending on individual tolerance.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a postmenopausal woman with no period for over 12 months and high FSH levels.
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I am fluent in either English or French.
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I weigh at least 50kg if male, 45kg if female, and my BMI is between 18.0-30.0.
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I am not pregnant or breastfeeding.
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I am between 18 and 55 years old.
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I am a woman who has had surgery to remove my uterus and/or both ovaries.
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I agree to use condoms and avoid donating sperm during and 90 days after the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 36 hours post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 36 hours post-dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in ECGs
Changes in Vital Signs
Changes in clinical laboratory tests
+4 more
Secondary outcome measures
(AUC0-τ) Day 12 (AUC0-24) for Part 2
AR
AUC0-24 for Part 2
+12 more

Trial Design

8Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 2 (Multiple Ascending doses (MAD)): ATH-399AExperimental Treatment1 Intervention
Participants will receive once daily (QD) dose of ATH-399A capsules from Day 1 to Day 12 in fasted state.
Group II: Part 1b (High calorie): ATH-399AExperimental Treatment1 Intervention
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.
Group III: Part 1b (Fasting): ATH-399AExperimental Treatment1 Intervention
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.
Group IV: Part 1a (Single Ascending Doses (SAD)): ATH-399AExperimental Treatment1 Intervention
Participants will receive single oral dose of ATH-399A capsule in up to 5 ascending dose levels (5mg, 10mg, 20mg, 40mg, 80mg).
Group V: Additional Cohort (Ages 56-80 years old): ATH-399AExperimental Treatment1 Intervention
Participants will receive QD dose of ATH-399A capsules from Day 1 to Day 12 in fasted state following MAD dosing.
Group VI: Additional Cohort: (Ages 56-80 years old) PlaceboPlacebo Group1 Intervention
Participants will receive QD dose of placebo-matched to ATH-399A capsules from Day 1 to Day 12 in fasted state following MAD dosing.
Group VII: Part 1a (SAD): PlaceboPlacebo Group1 Intervention
Participants will receive single oral dose of placebo-matched to ATH-399A capsule.
Group VIII: Part 2 (MAD): PlaceboPlacebo Group1 Intervention
Participants will receive QD dose of placebo-matched to ATH-399A capsules from Day 1 to Day 12 in fasted state.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

NurrOn Pharmaceuticals, Inc.Industry Sponsor
HanAll BioPharma Co., Ltd.Lead Sponsor
15 Previous Clinical Trials
1,903 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age limitation for enrollment in this trial restricted to those under 30?

"To be eligible to take part in this experiment, an individual must fall within the age range of 18-80; 66 studies are currently recruiting under-18s and 401 cater to individuals above 65."

Answered by AI

Who is eligible to participate in this experiment?

"To qualify for this experiment, candidates must be healthy and betwixt 18 to 80 years of age. 76 people will be accepted into the project."

Answered by AI

How many individuals are receiving treatment as part of this clinical trial?

"Affirmative. Information from clinicaltrials.gov confirms that the trial is currently recruiting patients, with 76 individuals needed to be enrolled at a single medical centre. The study was initially posted on September 19th 2023 and last updated October 11th of the same year."

Answered by AI

Has the FDA sanctioned Part 1a (Single Ascending Doses (SAD)): ATH-399A?

"Our team has given Part 1a (Single Ascending Doses (SAD)): ATH-399A a score of 1 on the safety scale due to its limited Phase 1 clinical trial data in terms of both efficacy and security."

Answered by AI

Are there any unfilled opportunities to take part in this experimental research?

"Affirmative. According to records on clinicaltrials.gov, this research endeavor is currently enrolling participants; the trial was initially posted on September 19th 2023 and recently updated October 11th 2023. 76 patients are being sought after from one medical facility."

Answered by AI

What aims are this research endeavor striving to accomplish?

"HanAll BioPharma Co., Ltd. has reported that the primary outcome of this trial will be evaluated using Columbia Suicidality Severity Rating Scale (C-SSRS) between Day 8 and 11 for Part 1a, 16 to 19 for Part 1b, and 13 for Part 2. Additionally, AUC0-inf (Area Under The Concentration-Time Curve From Time Zero To Infinity), Cmax (Maximal Observed Concentration), and Tmax (Time When The Maximal Concentration Is Observed) are all secondary outcomes which must also be assessed during these designated intervals."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study Assessing the Safety of Oral ATH-399A in Healthy Adult Participants
2023. "A Study Assessing the Safety of Oral ATH-399A in Healthy Adult Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06088784.
~48 spots leftby Apr 2025
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