SP16 SERPIN-like Peptide Administration in Healthy Individuals

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: SP16
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: This study is set up as 3 sequential parallel studies, each testing a different drug dosage against placebo. In each dosing cohort, three patients (2 active and 1 placebo) will be randomized to receive a single study drug infusion on separate days, at least 24 hours apart. The remaining subjects in each dosing cohort (1 placebo and 4 active) will receive study drug after at least 24 hours from the 3rd subject.
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute myocardial infarction, inflammation