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SP16 SERPIN-like Peptide Administration in Healthy Individuals

NCT03651089 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-07-28

No results posted yet for this study

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.

Conditions

  • Healthy Participants

Interventions

DRUG

SP16

subcutaneous injection of experimental anti-inflammatory drug

DRUG

Placebos

subcutaneous injection of sterile saline

Sponsors & Collaborators

  • George Mason University

    collaborator OTHER

  • Virginia Commonwealth University

    collaborator OTHER

  • Serpin Pharma, LLC

    lead OTHER

Principal Investigators

  • Antonio Abbate, MD, PhD · Virginia Commonwealth University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-16
Primary Completion
2019-01-15
Completion
2019-01-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03651089 on ClinicalTrials.gov