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

Atherosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05574166
• Other study ID #: SP-8356-1001
• Secondary ID: 2020-001216-23
• Status: Terminated
• Phase: Phase 1
• Start date: January 3, 2021
• Est. completion date: October 29, 2021

Study information

• Verified date: October 2022
• Source: Shin Poong Pharmaceutical Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: October 29, 2021
• Est. primary completion date: October 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Ischemic Stroke

Intervention

Drug:
• SP-8356
SP-8356 demonstrates anti-atherosclerotic and anti-ischaemic activity as a novel CD147 inhibitor.
• Placebo
Placebo for SP-8356 powder

Locations

Country	Name	City	State
United Kingdom	Quotient Sciences	Nottingham	Mere Way Ruddington Fields Ruddington

Sponsors (1)

Lead Sponsor	Collaborator
Shin Poong Pharmaceutical Co. Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	(Part 1)To investigate the safety and tolerability of single oral doses of SP-8356 in healthy male subjects	Incidence of adverse events (AEs), and assessment of physical examinations, safety laboratory tests, vital signs, electrocardiograms (ECGs) and ophthalmologic examinations	up to 3days
Secondary	(Part 1)To characterise the pharmacokinetic (PK) profile of single oral doses of SP-8356 Maximum Observed Drug Concentration (Cmax)	Evaluate Maximum Observed Drug Concentration (Cmax) of SP-8356.	up to 3days
Secondary	(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[0-8])	Evaluate Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-8]) of SP-8356.	up to 3days
Secondary	(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)	Evaluate the effect of food on Maximum Observed Drug Concentration (Cmax) of SP-8356.	up to 3days
Secondary	(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[0-8])	Evaluate the effect of food on Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-8]) of SP-8356.	up to 3days