None listed
Conditions
Brief summary
This is a first-in-human, Phase 1, single-center study that will evaluate single ascending doses (SAD) and multiple ascending doses (MAD) of EmtinB conducted in 2 parts. Part 1 (SAD) of this study will be conducted in approximately 40 healthy participants in up to 5 groups. Each group will consist of up to 8 participants who will be randomized to receive a single dose of EmtinB or placebo. Part 2 (MAD) of this study will be conducted in approximately 32 healthy participants in up to 4 groups and will commence after safety data for the highest dose in the SAD phase has been evaluated. Each group will consist of up to 8 participants who will be randomized to receive 7 daily doses of EmtinB or placebo.
Interventions
Treatment: Drugs - EmtinB subcutaneous injection
Experimental: Single Ascending Doses of EmtinB at planned dose levels of 10 mg/30 mg/60 mg/101.25 mg/150 mg administered on a single occasion.
Experimental: Multiple Ascending Doses of EmtinB at planned dose levels of 30 mg/60 mg/101.25 mg/150 mg administered once daily for 7 days. This part will commence following completion of all single dose cohorts. Participants who completed a Single Ascending Dose cohort may not also participate in a Multip
Treatment: Drugs - EmtinB subcutaneous injection Experimental: Single Ascending Doses of EmtinB at planned dose levels of 10 mg/30 mg/60 mg/101.25 mg/150 mg administered on a single occasion. Experimental: Multiple Ascending Doses of EmtinB at planned dose levels of 30 mg/60 mg/101.25 mg/150 mg administered once daily for 7 days. This part will commence following completion of all single dose cohorts. Participants who completed a Single Ascending Dose cohort may not also participate in a Multiple Ascending Dose cohort. Treatment: Drugs: EmtinB will be administered subcutaneously to the abdomen in single and multiple doses in the clinic by trained, qualified personnel. Each participant may only participate in a single cohort to receive either a single dose, or multiple doses once daily for 7 days.
Sponsors
NeuroScientific Biopharmaceuticals Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
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