SP16 SERPIN-like Peptide Administration in Healthy Individuals

NCT ID: NCT03651089

Last Updated: 2021-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-16
• Study Completion Date: 2019-01-23

Brief Summary

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.

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.

Conditions

Healthy Participants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

SP16 0.0125

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

Group Type: ACTIVE_COMPARATOR

SP16

Intervention Type: DRUG

subcutaneous injection of experimental anti-inflammatory drug

SP16 0.050

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

Group Type: ACTIVE_COMPARATOR

SP16

Intervention Type: DRUG

subcutaneous injection of experimental anti-inflammatory drug

SP16 0.20

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

Group Type: ACTIVE_COMPARATOR

SP16

Intervention Type: DRUG

subcutaneous injection of experimental anti-inflammatory drug

placebo

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

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

subcutaneous injection of sterile saline

Interventions

SP16

subcutaneous injection of experimental anti-inflammatory drug

Intervention Type: DRUG

Placebos

subcutaneous injection of sterile saline

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

George Mason University

OTHER

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: collaborator

Serpin Pharma, LLC

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonio Abbate, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Related Links

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0247357

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

Other Identifiers

01-SP16

Identifier Type: -

Identifier Source: org_study_id