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

NCT ID: NCT05574166

Last Updated: 2022-10-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-03
• Study Completion Date: 2021-10-29

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.

Conditions

Atherosclerosis; Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

SP-8356

Intervention Type: DRUG

SP-8356 demonstrates anti-atherosclerotic and anti-ischaemic activity as a novel CD147 inhibitor.

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo for SP-8356 powder

Interventions

SP-8356

SP-8356 demonstrates anti-atherosclerotic and anti-ischaemic activity as a novel CD147 inhibitor.

Intervention Type: DRUG

Placebo

Placebo for SP-8356 powder

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Shin Poong Pharmaceutical Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stuart Mair, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Quotient Sciences

Locations

Quotient Sciences

Nottingham, Mere Way Ruddington Fields Ruddington, United Kingdom

Countries

United Kingdom

Other Identifiers

2020-001216-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SP-8356-1001

Identifier Type: -

Identifier Source: org_study_id