Phase 1 Parkinson's Disease Trial, Recruiting NCT05995782 Sponsor: 1ST Biotherapeutics, Inc. Condition: Parkinson's Disease
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Phase 1 Parkinson's Disease Trial, Recruiting

NCT05995782
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are a healthy adult male between 19 and 55 years old (at the time of screening).
  • For one specific part of the trial (Part A, Cohort 5 only): you are a healthy male or female aged 60 or older, where females must not be able to become pregnant.
  • For elderly participants (Cohort 5 only): you may have a history of mild illness, but must be able to stop any current medications at least 2 weeks before the first dose, or as advised by the research team.
  • You have not smoked or used any nicotine products (such as patches or e-cigarettes) for at least 3 months before the study and agree not to use them during the study (based on self-reporting).
  • Your body mass index (BMI — a measure of body weight relative to height) is between 18 and 32.
  • You are in generally good health with no significant medical concerns based on health checks, physical exams, lab tests, heart tracings (ECGs), and vital signs, as judged by the study doctor.

Who may not be able to join:

  • You have significant mental health difficulties or are considered legally unable to make decisions for yourself.
  • You have a history of a significant medical or psychiatric (mental health) condition, as decided by the study doctor.
  • You have had any illness that might affect the study results or put you at extra risk, in the opinion of the study doctor.
  • You are considered to be at risk of suicide — this includes any suicide attempts in the past 12 months, any suicidal thoughts or plans in the past 3 months, or a specific "yes" answer on a standard suicide assessment questionnaire within the past 3 months.
  • You have had a problem with alcohol or drug misuse at any point in the past 2 years.
  • You have had an allergic or unusual reaction to the study drug or similar medications.
  • You have a history of seizures (epileptic fits), although childhood febrile (fever-related) seizures are an exception (confirm with trial site).
  • Your urine or breathalyser test comes back positive for drugs or alcohol at screening or when you check in for the study.
  • Your heart tracing (ECG) shows certain abnormal results, such as irregular heart rhythms or measurements outside of specific ranges, as judged by the study doctor.
  • You have a medical or surgical condition that means a lumbar puncture (a procedure to collect fluid from around the spine) would not be safe for you, in the opinion of the study doctor.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: 1STBIO study manager, 1ST Biotherapeutics, Inc.

Phone: +82-31-895-4677

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
1ST Biotherapeutics, Inc.
Registry
ClinicalTrials.gov
Start date
20 December 2023
Est. completion
1 December 2024

Where this trial is recruiting

🇰🇷 South Korea

Primary endpoints

Treatment Emergent Adverse Events (TEAE)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov