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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: SP16; Drug: Placebos

Detailed Description

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SP16 0.0125; 0.0125 mg/kg of SP16 will be administered by subcutaneous injection once	Drug: SP16; subcutaneous injection of experimental anti-inflammatory drug
Active Comparator: SP16 0.050; 0.050 mg/kg of SP16 will be administered by subcutaneous injection once	Drug: SP16; subcutaneous injection of experimental anti-inflammatory drug
Active Comparator: SP16 0.20; 0.20 mg/kg of SP16 will be administered by subcutaneous injection once	Drug: SP16; subcutaneous injection of experimental anti-inflammatory drug
Placebo Comparator: placebo; Placebo (sterile saline) will be administered by subcutaneous injection once	Drug: Placebos; subcutaneous injection of sterile saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preliminary Safety Assessment: Occurence of adverse events	Occurence of adverse events	7 days follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume of distribution of SP16 in healthy subjects	Population estimate of volume of distribution will be calculated using non-compartmental analysis	7 days
Clearance of SP16 in healthy subjects	Population estimate of clearance will be calculated using non-compartmental analysis	7 days

Collaborators and Investigators

• Sponsor: Serpin Pharma, LLC
• Collaborators: Virginia Commonwealth University; George Mason University

Publications and helpful links

Helpful Links

• A phase 1 clinical trial of SP16, a first-in-class anti-inflammatory LRP1 agonist, in healthy volunteers

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2018
• Primary Completion (Actual): January 15, 2019
• Study Completion (Actual): January 23, 2019

Study Registration Dates

• First Submitted: August 27, 2018
• First Submitted That Met QC Criteria: August 28, 2018
• First Posted (Actual): August 29, 2018

Study Record Updates

• Last Update Posted (Actual): July 28, 2021
• Last Update Submitted That Met QC Criteria: July 26, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: inflammation; acute myocardial infarction
• Other Study ID Numbers: 01-SP16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The investigators plan to present the data promptly upon analysis as an abstract to a national meeting and/or manuscript

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No