SP16 SERPIN-like Peptide Administration in Healthy Individuals

Serpin Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: SP16; Drug: Placebos

Study type: Interventional

Funder types: Other

Identifiers

NCT03651089

01-SP16

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 59 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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24 participants in 4 patient groups, including a placebo group

SP16 0.0125

Active Comparator group

Description:

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

Treatment:

Drug: SP16

SP16 0.050

Active Comparator group

Description:

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

Treatment:

Drug: SP16

SP16 0.20

Active Comparator group

Description:

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

Treatment:

Drug: SP16

placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebos