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

NCT05574166 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2022-10-10

No results posted yet for this study

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

Interventions

DRUG

SP-8356

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

DRUG

Placebo

Placebo for SP-8356 powder

Sponsors & Collaborators

  • Shin Poong Pharmaceutical Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Stuart Mair, MD, PhD · Quotient Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-03
Primary Completion
2021-10-28
Completion
2021-10-29

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05574166 on ClinicalTrials.gov