A Two-Part Single and Multiple Ascending Dose Trial of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LBT-3627 in Healthy Participants and in Participants With Parkinson's Disease.
Phase I a/b SAD/MAD study to evaluate safety and tolerability of LBT-3627 in both healthy volunteers and Parkinson's patients.
⁃ Participants will be included in the study only if they satisfy all the following criteria:
• Must have given written informed consent, before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
• Healthy male or female, aged between 30 and 89 years, inclusive at screening.
• Body mass index (BMI) of 18 to 32 kg/m2, inclusive.
• Physical examination without any additional clinically relevant findings
• Systolic blood pressure in the range of 90 to 140 mmHg (inclusive) and diastolic blood pressure in the range of 40 to 90 (inclusive) mmHg after 5 minutes in supine/semi-supine, and subsequently after 3 minutes of standing position.
• Note 1: Participants with orthostatic hypotension are not permitted. Orthostatic hypotension is defined as ≥ 20 mm Hg reduction in systolic blood pressure and/or ≥ 10 mm Hg reduction in diastolic blood pressure between supine/semi-supine versus subsequent standing measurements.
• Note 2 (For Parkinson's Patients): If systolic blood pressure \> 140 mmHg and/or diastolic blood pressure \> 90 mmHg, one repeat supine/semi-supine assessment is permitted within 5-10 minutes later, at the discretion of the PI (or delegate).
• Heart rate in the range of 50 to 100 beats/minute after 5 minutes rest in supine/semi-supine position, and subsequently after 3 minutes of standing position.
⁃ Note: Participants with orthostatic hypotension are not permitted. Orthostatic hypotension is defined as ≥ 30 beats/minute increase in heart rate between supine/semi-supine versus subsequent standing measurements.
⁃ 7\. Body temperature (tympanic), between 35.5°C and 37.5°C. 8. Electrocardiogram (ECG) without clinically significant abnormal including QT interval corrected for Fredericia (QTcF) \< 450 msec for male participants and \< 470 msec for female participants.
⁃ 9\. No clinically significant findings in serum chemistry, haematology, coagulation or urinalysis (in the opinion of the Investigator).
⁃ 10\. Female participants must be of non-child-bearing potential i.e., surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before the screening visit) or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause and a follicle-stimulating hormone \[FSH\] level consistent with postmenopausal status, per local laboratory guidelines), or, if of child-bearing potential:
• Must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test on Day -1, prior to dose administration.
• Must agree not to donate ova or attempt to become pregnant from the time of signing consent until at least 30 days after the last dose of study drug.
• If not exclusively in a same-sex relationship, must agree to remain abstinent throughout the study, or must agree to use adequate contraception (which is defined as use of a condom by the male partner combined with use of a highly effective method of contraception from one month prior to screening until at least 30 days after the last dose of study drug.
⁃ 11\. Male participants must:
• Agree not to donate sperm from the time of signing consent until at least 30 days after the last dose of study drug.
• If engaging in sexual intercourse with a female partner who could become pregnant, agree to use adequate contraception (defined as use of a condom plus a highly effective method of contraception from the time of signing consent until at least 30 days after the last dose of study drug.
• If engaging in sexual intercourse with a female partner who is not of childbearing potential or a same-sex partner, agree to use a condom from the time of signing consent until at least 30 days after the last dose of study drug.
⁃ 12\. Willing and able to comply with all scheduled visits, treatment plans, laboratory tests and other study procedures.