A Phase I Single-Centre, Randomised, Double-Blind, Placebo-Controlled Study in Healthy Volunteers to Evaluate the Safety, Tolerability, and Pharmacokinetics of Escalating Single Doses and Multiple Doses of SP-8356
Overview
- Phase
- Phase 1
- Intervention
- SP-8356
- Conditions
- Atherosclerosis
- Sponsor
- Shin Poong Pharmaceutical Co. Ltd.
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- (Part 1)To investigate the safety and tolerability of single oral doses of SP-8356 in healthy male subjects
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
Brief Summary
This is a 2-part, single-centre, randomised study in healthy males. Part 1 is a double-blind, randomised, placebo-controlled, single ascending dose (SAD) study in healthy males. Part 2 is a double-blind, randomised, placebo-controlled, multiple ascending dose (MAD) study in healthy males.
Detailed Description
2-part, single-centre, randomised study in healthy males. Part 1 is a double-blind, randomised, placebo-controlled, single ascending dose (SAD) study in healthy males. Part 2 is a double-blind, randomised, placebo-controlled, multiple ascending dose (MAD) study in healthy males.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy males
- •Aged 18 to 55 years, inclusive, at the time of signing informed consent
- •Body mass index (BMI) of 18.0 to 32.0 kg/m2 as measured at screening
- •Must be willing and able to communicate and participate in the whole study
- •Must provide written informed consent
- •Must agree to adhere to the contraception requirements
Exclusion Criteria
- •Subjects who have received any IMP in a clinical research study within the 90 days prior to the planned first dosing date
- •Subjects who are, or are immediate family members of a study site or sponsor employee
- •Evidence of recent or current SARS-CoV-2 infection. A minimum period of 3 months from resolution of COVID-19 symptoms to dosing must have passed
- •Subjects who have previously been administered IMP in this study.
- •Subjects who have taken part in Part 1 are not permitted to take part in Part 2
- •History of any drug or alcohol abuse in the past 2 years
- •Regular alcohol consumption in males \> 21 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 Units = 125 mL glass of wine, depending on type)
- •A confirmed positive alcohol breath test at screening or admission
- •Current smokers and those who have smoked within the last 12 months. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission
- •Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
Arms & Interventions
SP-8356 powder
Part1 will consist of escalating single doses in five sequential cohorts. Each dose level cohort will consist of 8 subjects: 6 subjects will receive SP-8356 and 2 subjects will receive placebo in fasted state according to the randomization schedule. Subjects in Cohort 3 will receive a single dose of SP-8356 or placebo in the fasted then fed state on separate dosing occasions.
Intervention: SP-8356
Placebo
Part1 will consist of escalating single doses in five sequential cohorts. Each dose level cohort will consist of 8 subjects: 6 subjects will receive SP-8356 and 2 subjects will receive placebo in fasted state according to the randomization schedule. Subjects in Cohort 3 will receive a single dose of SP-8356 or placebo in the fasted then fed state on separate dosing occasions.
Intervention: Placebo
Outcomes
Primary Outcomes
(Part 1)To investigate the safety and tolerability of single oral doses of SP-8356 in healthy male subjects
Time Frame: up to 3days
Incidence of adverse events (AEs), and assessment of physical examinations, safety laboratory tests, vital signs, electrocardiograms (ECGs) and ophthalmologic examinations
Secondary Outcomes
- (Part 1)To characterise the pharmacokinetic (PK) profile of single oral doses of SP-8356 Maximum Observed Drug Concentration (Cmax)(up to 3days)
- (Part 1)]To characterise the pharmacokinetic (PK) profile of single oral doses of SP-8356- Area under the plasma concentration versus time curve from time zero to infinity (AUC[0-∞])(up to 3days)
- (Part 1)To characterise the effect of food on the PK profile of SP-8356 following single oral doses of SP-8356 Maximum Observed Drug Concentration (Cmax)(up to 3days)
- (Part 1)To characterise the effect of food on the PK profile of SP-8356 following single oral doses of SP-8356 - Area under the plasma concentration versus time curve from time zero to infinity (AUC[0-∞])(up to 3days)