Parkinson's Disease
Conditions
Interventions
CST-101, CST-103 and CST-109
Sponsors
CuraSen Therapuetics, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Main inclusion criteria healthy volunteers: 1. Males and females aged 35-60 years (inclusive) at the time of informed consent 2. Unless confirmed to be azoospermic (vasectomized or secondary to medical cause), males must agree to use a male condom plus partner use of an additional contraceptive method throughout the study when having penile-vaginal intercourse with a woman of childbearing potential who is not currently pregnant. Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a condom during each episode of penile-vaginal penetration. 3. Females of childbearing potential (i.e., not postmenopausal or surgically sterile) must agree to one of the following from start of Screening through 90 days after the last study drug administration: a. use two effective methods of birth control, including hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, contraceptive ring, intrauterine device, barrier method (e.g., condoms, diaphragm, or cervical cap) or spermicidal foam, cream or gel, or b. practice complete abstinence, or c. monogamous relationship with a male partner of confirmed sterility. 4. Body weight equal to or greater than 50 kg and body mass index (BMI) between 18 and 35 kg/m2, inclusive at Screening 5. Participant is free from clinically significant illness or disease as determined by medical and surgical history, physical examination, 12-lead ECG and clinical laboratory assessments conducted at Screening and Day -1 as agreed to by the Investigator and Medical Monitor. 6. No current use of any prescription medication, over-the-counter medication, or herbal supplements/products during Screening or throughout study, unless approved by both the Investigator and the Sponsor 7. Able to understand and sign the written Informed Consent Form (ICF) 8. Able to communicate well with the Investigator in the Dutch language and willing to follow the protocol requirements and comply with protocol restrictions Main Inclusion criteria Parkinson patients: 1. Males and females aged 40-75 years (inclusive) at the time of informed consent 2. Unless confirmed to be azoospermic (vasectomized or secondary to medical cause), males must agree to use a male condom plus partner use of an additional contraceptive method throughout the study when having penile-vaginal intercourse with a woman of childbearing potential who is not currently pregnant. Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a condom during each episode of penile-vaginal penetration. 3. Females of childbearing potential (i.e., not postmenopausal or surgically sterile) must agree to one of the following from start of Screening through 90 days after the last study drug administration: a. use two effective methods of birth control, including hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, contraceptive ring, intrauterine device, barrier method (e.g., condoms, diaphragm, or cervical cap) or spermicidal foam, cream or gel, or b. practice complete abstinence, or c. monogamous relationship with a male partner of confirmed sterility. 4. Patient who has Parkinson*s disease (PD) defined by the
Exclusion criteria
Exclusion criteria: Main exclusion criteria all volunteers: 1. History of any clinically significant disease, as assessed by the Investigator, including cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, metabolic, psychological, musculoskeletal disease, or malignancies 2. Participants with a history (in the 5 years prior to Screening) of malignant disease, including solid tumors and hematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured) 3. A calculated creatinine clearance of 450 msec for males and >470 msec for females 13. History of angina, uncontrolled hypertension, heart failure, coronary insufficiency, cardiac arrythmias, diabetes mellitus, hyperthyroidism, convulsion disorders, bronchial asthma, sinus bradycardia and greater than first degree conduction block, cardiogenic shock 14. Participation in an investigational drug or device study within 3 months prior to first dosing, or current enrollment in any other study treatment or disease study 15. Prior treatment with any β-AR agonists or β-AR blockers within the month prior to study enrollment for healthy subjects 16. Donation or loss of >=500 mL of blood or blood products within 30 days prior to dosing 17. Any other reason for which the Investigator considers it is not in the best interest of the participant to undertake the stud
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints are: Parts A, B, and C 1. Measures of CNS activity captured in the NeuroCart, which include: a. Saccadic Eye Movement b. Smooth pursuit eye movement c. Adaptive tracking d. Body sway e. Visual Verbal Learning Test with emotional Valence f. Stroop test g. Visual analogue scale (VAS) Bond and Lader h. VAS Bowdle i. Electroencephalography (EEG) j. Pupillometry k. Dual Task Test l. Choice Reaction Time Test m. N-back Test | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are: 1. Adverse events (AEs), electrocardiograms (ECGs), vital signs, laboratory safety tests (hematology, chemistry, and urinalysis) 2. Heart rate and blood pressure | — |
Countries
Netherlands
Outcome results
None listed