A Phase I Study to Evaluate Safety and Pharmacokinetics of Escalating Single Doses and Multiple Doses of SP-8356

Phase 1

Terminated

• Conditions: Atherosclerosis; Ischemic Stroke
• Interventions: Drug: SP-8356; Drug: Placebo

• Registration Number: NCT05574166
• Lead Sponsor: Shin Poong Pharmaceutical Co. Ltd.

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.

Study Timeline

• Study Start: 2021-01-03
• Primary Completion: 2021-10-28
• Study Completion: 2021-10-29
• Status Verified: 2022-10
• Study First Submitted: 2022-10-06
• Study First Submitted QC: 2022-10-06
• Last Update Submitted: 2022-10-06
• Study First Posted: 2022-10-10
• Last Update Posted: 2022-10-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 31

Inclusion Criteria

1. Healthy males
2. Aged 18 to 55 years, inclusive, at the time of signing informed consent
3. Body mass index (BMI) of 18.0 to 32.0 kg/m2 as measured at screening
4. Must be willing and able to communicate and participate in the whole study
5. Must provide written informed consent
6. Must agree to adhere to the contraception requirements

Exclusion Criteria

1. Females
2. Subjects who have received any IMP in a clinical research study within the 90 days prior to the planned first dosing date
3. Subjects who are, or are immediate family members of a study site or sponsor employee
4. 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
5. Subjects who have previously been administered IMP in this study.
6. Subjects who have taken part in Part 1 are not permitted to take part in Part 2
7. History of any drug or alcohol abuse in the past 2 years
8. 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)
9. A confirmed positive alcohol breath test at screening or admission
10. 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
11. Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
12. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening
13. Clinically significant abnormal biochemistry, haematology, or urinalysis as judged by the investigator. Subjects with Gilbert's Syndrome are not allowed
14. Subjects that have either a known of family history of QT prolongation or chronic QT prolongation syndrome (i.e. QTc > 450 msec) in repeated ECG
15. Subjects with any clinically significant medical disorders increasing tendency to bleed easily, or having history of recent trauma or surgery, or having history of gout or renal stones
16. Subjects with a clinically significant history of skin disorder such as photosensitivity, eczema or psoriasis.
17. Subjects with a clinically significant history of eye disorders that may affect the interpretation of the ophthalmology assessments as per the judgement of the investigator (only for subjects where ophthalmology assessments will be performed).
18. Confirmed positive drugs of abuse test result
19. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results
20. Evidence of renal impairment at screening, as indicated by an estimated glomerular filtration rate (eGFR) of <80 mL/min/1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
21. History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator
22. Subjects with a history of cholecystectomy or gall stones (Part 1 Cohort 3 only)
23. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
24. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
25. Donation or loss of greater than 400 mL of blood within the previous 3 months
26. Has a history of photosensitivity or photoallergy
27. Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than up to 4 g of paracetamol per day) in the 14 days before IMP administration Exceptions may apply on a case by case basis, if considered not to interfere with the objectives of the study, as determined by the investigator
28. Is taking medication known to cause phototoxic reactions (e.g., tetracyclines, thiazides, nonsteroidal anti-inflammatory drugs) within 4 weeks of enrolling into the study
29. Failure to satisfy the investigator of fitness to participate for any other reason

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SP-8356 powder	SP-8356	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.
Placebo	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.

Primary Outcome Measures

Name	Time	Method
(Part 1)To investigate the safety and tolerability of single oral doses of SP-8356 in healthy male subjects	up to 3days	Incidence of adverse events (AEs), and assessment of physical examinations, safety laboratory tests, vital signs, electrocardiograms (ECGs) and ophthalmologic examinations

Secondary Outcome Measures

Name	Time	Method
(Part 1)To characterise the pharmacokinetic (PK) profile of single oral doses of SP-8356 Maximum Observed Drug Concentration (Cmax)	up to 3days	Evaluate Maximum Observed Drug Concentration (Cmax) of SP-8356.
(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	Evaluate Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC\[0-∞\]) of SP-8356.
(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	Evaluate the effect of food on Maximum Observed Drug Concentration (Cmax) of SP-8356.
(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	Evaluate the effect of food on Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC\[0-∞\]) of SP-8356.

Trial Locations

Locations (1)

Quotient Sciences; 🇬🇧 Nottingham, Mere Way Ruddington Fields Ruddington, United Kingdom