None listed
Conditions
Brief summary
This study is testing the safety and tolerability of a single dose of SCS1 in healthy participants. Approximately 40 participants will be enrolled consecutively across multiple escalating dose cohorts to receive a single oral dose of SCS1 or placebo. Cohorts will proceed following satisfactory review of the prior cohort data (including the safety and tolerability data). Cohorts will be determined by escalations of not more than 5-fold. The study hypothesis is that the doses planned for administration will be safe and well tolerated.
Interventions
The primary and secondary objectives of the study are to evaluate the safety, tolerability, and pharmacokinetics of a single oral dose of SCS1. Escalating doses will be administered based on participant body weight in each of up to 6 cohorts with scheduled doses of each cohort as follows: cohort 1 = 2 mg/kg, cohort 2 = 8 mg/kg, cohort 3 = 24 mg/kg, cohort 4 = 72 mg/kg, cohort 5 = 160 mg/kg, and cohort 6 = 324 mg/kg of SCS1. Participants will receive study intervention directly from the invest
The primary and secondary objectives of the study are to evaluate the safety, tolerability, and pharmacokinetics of a single oral dose of SCS1. Escalating doses will be administered based on participant body weight in each of up to 6 cohorts with scheduled doses of each cohort as follows: cohort 1 = 2 mg/kg, cohort 2 = 8 mg/kg, cohort 3 = 24 mg/kg, cohort 4 = 72 mg/kg, cohort 5 = 160 mg/kg, and cohort 6 = 324 mg/kg of SCS1. Participants will receive study intervention directly from the investigator (or designee), under medical supervision. Escalating dose cohorts will commence only after safety review of the prior cohort (e.g. cohort 2 will commence only after safety review of cohort 1) including review from follow-up visit (on day 7, 8, or 9 relative to the day of dosing). Doses will be administered orally as a liquid.
Sponsors
Sydney Cove Sciences Pty Ltd
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female, of any race, between 18 and 55 years of age. 2. Body mass index between 18.0 and 32.0 kg/m2, inclusive. 3. In good health
Exclusion criteria
1. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder 2. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
Outcome results
None listed