SP16 SERPIN-like Peptide Administration in Healthy Individuals

Serpin Pharma, LLC24 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Healthy Participants

Interventions

SP16DRUG

subcutaneous injection of experimental anti-inflammatory drug

PlacebosDRUG

subcutaneous injection of sterile saline

Eligibility

Sex: ALLMin age: 18 YearsMax age: 59 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Virginia Commonwealth University

Richmond, Virginia, United States

Outcomes

Primary Outcomes

Preliminary Safety Assessment: Occurence of adverse events

Occurence of adverse events

Time frame: 7 days follow-up

Secondary Outcomes

Volume of distribution of SP16 in healthy subjects

Population estimate of volume of distribution will be calculated using non-compartmental analysis

Time frame: 7 days

Clearance of SP16 in healthy subjects

Population estimate of clearance will be calculated using non-compartmental analysis

Time frame: 7 days

Data from ClinicalTrials.gov

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