SP16 SERPIN-like Peptide Administration in Healthy Indivi... | NCT03651089

Studies
SP16 SERPIN-like Peptide Administration in Healthy Individuals

NCT03651089

Sponsor

Serpin Pharma, LLC

Status

Completed

Last Update Posted

Jul 28, 2021Actual

Enrollment

24Actual

Phase

Phase 1

Conditions

Healthy Participants

Interventions

SP16
Placebos

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 16, 2018Actual

Primary Completion Date

Jan 15, 2019Actual

Completion Date

Jan 23, 2019Actual

First Submitted Date

Aug 27, 2018

First Submission Date that Met QC Criteria

Aug 28, 2018

First Posted Date

Aug 29, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 26, 2021

Last Update Posted Date

Jul 28, 2021Actual

Name	Class
George Mason University	OTHER
Virginia Commonwealth University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SP16 0.0125	Active Comparator	0.0125 mg/kg of SP16 will be administered by subcutaneous injection once	Drug: SP16
SP16 0.050	Active Comparator	0.050 mg/kg of SP16 will be administered by subcutaneous injection once	Drug: SP16
SP16 0.20	Active Comparator	0.20 mg/kg of SP16 will be administered by subcutaneous injection once	Drug: SP16
placebo	Placebo Comparator	Placebo (sterile saline) will be administered by subcutaneous injection once	Drug: Placebos

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SP16	Drug	subcutaneous injection of experimental anti-inflammatory drug	SP16 0.0125 SP16 0.050 SP16 0.20

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

59 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Antonio Abbate, MD, PhD	Virginia Commonwealth University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Virginia Commonwealth University		Richmond	Virginia	23298	United States

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

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

The investigators plan to present the data promptly upon analysis as an abstract to a national meeting and/or manuscript

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D007249	Inflammation

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Intervention 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.