Trial | NCT03651089  Report issue

Title

SP16 SERPIN-like Peptide Administration in Healthy Individuals
Safety, Tolerability and Pharmacokinetics of a Single Subcutaneous Administration of SP16-a SERPIN-like, Small Peptide Agonist of the Low Density Lipoprotein-like Receptor 1-in Healthy Individuals

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    SP16 ...

  • Study Participants

    24
This study is a randomized, double-blind, placebo-controlled Phase 1 Clinical Trial of 24 healthy individuals to test the safety, tolerability and pharmacokinetics of a single subcutaneous administration of Serpin Peptide 16 (SP16), a Serine Protease Inhibitor (Serpin)-like, small peptide agonist of the Low Density Lipoprotein Receptor-like Protein 1 (LRPP1) hypothesized to have anti-inflammatory activity.
One of the major determinants for outcome in patients with acute myocardial infarction (AMI) is the degree of inflammatory response. SP16 is a synthetic anti-inflammatory peptide developed to reproduce the anti-inflammatory activities of naturally occurring Serpins and has been tested as a treatment for AMI in mice. This Phase I trial will be the first to test the hypothesis that a single subcutaneous administration of SP16 is safe and well tolerated in healthy individuals, while also assessing the pharmacokinetic parameters of three different dosages. Participants will undergo direct clinical monitoring for up to 12 hours after drug administration. Additionally, participants will follow up with the same assessments at 24 hours, 48-72 hours and 7 days post drug administration.
Study Started
Jul 16
2018
Primary Completion
Jan 15
2019
Study Completion
Jan 23
2019
Last Update
Jul 28
2021

Drug SP16

subcutaneous injection of experimental anti-inflammatory drug

Drug Placebos

subcutaneous injection of sterile saline

SP16 0.0125 Active Comparator

0.0125 mg/kg of SP16 will be administered by subcutaneous injection once

SP16 0.050 Active Comparator

0.050 mg/kg of SP16 will be administered by subcutaneous injection once

SP16 0.20 Active Comparator

0.20 mg/kg of SP16 will be administered by subcutaneous injection once

placebo Placebo Comparator

Placebo (sterile saline) will be administered by subcutaneous injection once

Criteria 

Inclusion Criteria:

Written informed consent
Age 18 to 59 years
Stated willingness to comply with all study procedures and availability for the duration of the study
Ability to take oral medication and be willing to adhere to the medication regimen
For females of reproductive potential: Use of highly effective contraception
For males of reproductive potential: Use of condoms

Exclusion Criteria:

Acute or chronic illness affecting organ function or requiring medications (including, but not limited to, cardiovascular, hepatic, renal hematologic, neurologic, dermatologic, psychiatric, or rheumatologic disease);
Febrile illness within the previous 14 days;
Known allergic reactions to components of the study agent;
Treatment with another investigational drug or other intervention within 30 days;
Current tobacco use or tobacco use within 60 days;
Household contacts who are immunocompromised;
Chronic infection(s) (of any kind);
Malignancy (of any kind);
Substance abuse disorder(s);
Pregnancy or breastfeeding;
Any other conditions that would place the subject at increased risk of adverse events or interfere with the conduct or interpretation of the study, in the opinion of the investigators.
No Results Posted