Parkinson's Disease
Conditions
Interventions
Part A:Cohort 1 : 25 mg OD YTX-7739 / matching placebo. The dose of cohort 2
and part B will be based on emerging data from cohort 1. Cohort A2 and cohorts
in part B will be dosed for 28 days. The m
Sponsors
Yumanity Therapeutics
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
Exclusion criteria: Part A: 1. Clinically significant findings as determined by medical history taking, physical examination, fundoscopy, ECG, laboratory findings (abnormal lipid or hormone profile) and vital signs; 2. Hemodynamic status at screening: systolic blood pressure 160 mmHg, diastolic blood pressure 95 mmHg, heart rate 100 bpm measured; Part B: 3. Clinically significant findings as determined by medical history taking, MRI (Part B, cohort 4 only), physical examination, fundoscopy, ECG and vital signs, other than 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Safety: 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. - Pharmacokinetic: 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). | — |
Countries
Netherlands
Outcome results
None listed