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

NCT05574166 | Terminated Phase 1 DMC

• 2 other identifiers: SP-8356-10012020-001216-23
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Atherosclerosis; Ischemic Stroke

Keywords

SP-8356; Shinpoong; atherosclerosis; ischaemic stroke

Outcome Measures

Primary Outcomes (1)

• (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 Outcomes (4)

• (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

Study Arms (2)

SP-8356 powder

EXPERIMENTAL

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.

Drug: SP-8356

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

SP-8356 DRUG

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

SP-8356 powder

Placebo DRUG

Placebo for SP-8356 powder

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Females
• 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
• Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening
• Clinically significant abnormal biochemistry, haematology, or urinalysis as judged by the investigator. Subjects with Gilbert's Syndrome are not allowed
• 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
• 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

Sponsors & Collaborators

• Shin Poong Pharmaceutical Co. Ltd.: lead

Study Sites (1)

Quotient Sciences

Nottingham, Mere Way Ruddington Fields Ruddington, NG11 6JS, United Kingdom

Location

MeSH Terms

Conditions

Atherosclerosis; Ischemic Stroke

Interventions

SP-8356

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Stuart Mair, MD, PhD

  Quotient Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose escalation

Study Record Dates

• First Submitted: October 6, 2022
• First Posted: October 10, 2022
• Study Start: January 3, 2021
• Primary Completion: October 28, 2021
• Study Completion: October 29, 2021
• Last Updated: October 10, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)