None listed
Conditions
Brief summary
This Phase 1 study will comprise a single group conducted in up to 8 participants who will receive a single dose of EmtinB in an open-label fashion. In addition to safety, tolerability and pharmacokinetics (PK), a single cerebrospinal fluid (CSF) sample will be collected from each participant via lumbar puncture to assess the ability of EmtinB to cross the blood brain barrier.
Interventions
Experimental: Single dose of EmtinB at planned dose level of 150 mg administered on a single occasion. EmtinB will be administered subcutaneously to the abdomen as a single dose in the clinic by trained, qualified personnel.
Sponsors
NeuroScientific Biopharmaceuticals Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Generally healthy with the exception of those medical conditions allowed per the inclusion/exclusion criteria. 2. Adult male and female participants aged greater than or equal to 18 and less than or equal to 60 years at the time of screening.
Exclusion criteria
1. Presence or history of any cardiovascular, gastrointestinal, renal, hepatic, respiratory, hematological,lymphatic, immunological, dermatological, neurological, musculoskeletal, connective tissue, genitourinary,endocrine or psychiatric diseases or disorders, which are determined as clinically relevant by the investigator as they would make implementation of the protocol or interpretation of the study data difficult, or would put the participant at risk by participation in the study in the opinion of the investigator.. 2. Any evidence or treatment of malignancy (other than localized basal cell cancer, squamous cell skin cancer, or cancer in situ that has been resected or successfully treated with topical therapy e.g. Aldara) within the previous 5 years. 3. Abnormal ECG, and deemed clinically significant by the investigator, at screening and/or Day -1 defined as; QTcF >450 msec (males) or >470 msec (females). 4. Clinically significant renal disease, nephrectomy, renal transplant or estimated glomerular filtration rate of <90 mL/min/1.73 m^2 at screening based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation 2009. 5. Abnormal vital sign findings (after resting semi-supine for 5 minutes) defined as: • Blood pressure that is >140 mm Hg or <90mm Hg systolic, or >90 mm Hg or <40 mm Hg diastolic at screening or Day -1. • Pulse rate that is <40 or >100 bpm at screening or Day -1. 6. Used or are using over-the-counter medications, dietary/nutritional supplements (except for occasional paracetamol, up to 2 g in any 1 day) within 7 days prior to first dose on Day 1 until completion of the EOS visit. 7. Used or are using prescription medications (except stable female contraceptives that must continue uninterrupted for the duration of the study) within 14 days or 5 half-lives prior to first dose on Day 1 (whichever is longer) until completion of the EOS visit. 8. Used or are using systemic steroids (orally or intravenously administered) within 28 days prior to first dose on Day 1 until completion of EOS visit.
Outcome results
None listed