Multiple dose study of YTX-7739

Recruiting

• Conditions: Parkinson's Disease

• Registration Number: NL-OMON20317
• Lead Sponsor: Yumanity Therapeutics

Brief Summary

.A.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 48

Inclusion Criteria

Part A
1. Adult male or female subjects 18-55 years of age, inclusive.
Part B
2. Male or female subjects 40-75 years of age, inclusive, with a confirmed diagnosis of Parkinson’s disease (Hoehn and Yahr grade 1-3.

Part A + B
3. Healthy status as defined by absence of evidence of any significant active acute or chronic disease or illness following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry and urinalysis, as judged by the investigator;
4. Body mass index (BMI) between 18-32 kg/m2, inclusive, and with a minimum weight of 50kg and maximum weight of 120kg
5. If subject is a female, she agrees to report onset and duration of menses if it occurs anytime during participation in the study (screening to end of study)
6. Evidence of a personally signed and witnessed informed consent document indicating that the subject has been informed of all pertinent aspects of the study;

Exclusion Criteria

Part A:
1. Clinically significant findings as determined by medical history taking, physical examination, , fundoscopy, ECG, laboratory findings (including lipid or hormone profiles) and vital signs;
2. Hemodynamic status at screening: systolic blood pressure <100 or >160 mmHg, diastolic blood pressure <50 or >95 mmHg, heart rate <45 or >100 bpm;

Part B:
3. Clinically significant findings as determined by medical history taking, MRI, physical examination, fundoscopy, ECG and vital signs, other that Parkinson’s disease;
4. Any current, clinically significant, known medical condition other than Parkinson’s disease. Patients with a diagnosis of neurological diseases, other than Parkinson’s disease, including Alzheimer’s disease, Huntington’s disease, vascular dementia, progressive supranuclear gaze palsy, multiple system atrophy, drug-induced parkinsonism, essential tremor, primary dystonia, epilepsy, etc., that are considered clinically relevant by the investigator.
5. Dementia indicated by MMSE <18 at Screening;
6. Use of drugs known to prolong QT interval;
7. Hemodynamic status at screening: results that are considered clinically relevant by the investigator;
8. Any contra-indication to performing a MRI (including (an history of) a cardiac pacemaker, implanted cardiac defibrillator, neurostimulator, hydrocephalus pomp, drug pump, stents or clips in vessels, non-removable hearing aid, non-removable implants containing a magnet in the jaw, tissue expander in the breast, IUD, metal splinters of fragments in the body, non-removable medication patch, tattoo or permanent make-up applied less than 6 weeks ago, non-removable piercing, non-removable hair extensions containing metal);
9. An history of claustrophobia, tinnitus or hyperacusis;
10. An history of allergic reaction during previous MRI examination;
11. History of repeated head injury; history of epilepsy or seizure disorder other than febrile seizures as a child
12. Reside in a nursing home or assisted care facility
13. Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the participant in this study or interfere with the participant's ability to comply with study procedures or abide by study restrictions, or with the ability to interpret safety data
14. Prior lack of response to dopaminergic medication (for example, levodopa or a dopaminergic agonist)
15. Continuous use of any of the following within 30 days prior to baseline: antipsychotics (including clozapine and olanzapine), metoclopramide, alpha methyldopa, clozapine, olanzapine, flunarizine, amoxapine, amphetamine derivatives, reserpine, bupropion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, norephedrine, phentermine, phenylpropanolamine, and modafinil. Single use up to 7 days prior to the start of the study is allowed for metoclopramide.

Part A + B
16. Legal incapacity or inability to understand or comply with the requirements of the study;
17. Subjects with a QTcF of > 450 ms for males and > 470 ms for females at screening or a history of long QT syndrome;
18. Any current, clinically significant, known medical condition;
19. Pregnant, lactating or breast-feeding women
20. Have a urine drug screen detecting illicit drug(s) of abuse (morphine, benzodiazepines, cocaine, amphetamine, THC) or positive alcohol breath test at sc

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Safety:<br>o Safety and tolerability of YTX-7739 will be measured by assessing the severity and incidence of treatment-emergent adverse events (TEAEs), clinical laboratory tests, ECGs, vital signs and physical examinations.<br>- Pharmacokinetic:<br>o The non-compartmental PK parameters of YTX-7739 will be estimated including AUC, C(max), T(max), elimination half-life (t1/2) and elimination rate constant (Ke).