Healthy ParticipantsPhase 1NCT03651089

SP16 SERPIN-like Peptide Administration in Healthy Individuals

A Phase 1 study testing SP16 in people with Healthy Participants, run by Serpin Pharma, LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 18 to 59 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Participants
What is being tested?: SP16
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 1 siteUnited States
Study dates: 16 Jul 2018to 23 Jan 2019
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 59 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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;

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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 locations and contacts

1 site in 1 country.

United States1 site

Virginia Commonwealth University
Richmond, Virginia, 23298

Other trials in United States

About this study

Official title: 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

Read the 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.

Conditions: Healthy Participants
Being tested: SP16, Placebos
Keywords: acute myocardial infarction, inflammation
Medical subject headings: Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SP16Drug
subcutaneous injection of experimental anti-inflammatory drug
PlacebosDrug
subcutaneous injection of sterile saline

Study groups in NCT03651089
Study group	Role	What they receive
SP16 0.0125	Active comparator	0.0125 mg/kg of SP16 will be administered by subcutaneous injection once Receives: Drug: SP16
SP16 0.050	Active comparator	0.050 mg/kg of SP16 will be administered by subcutaneous injection once Receives: Drug: SP16
SP16 0.20	Active comparator	0.20 mg/kg of SP16 will be administered by subcutaneous injection once Receives: Drug: SP16
placebo	Placebo comparator	Placebo (sterile saline) will be administered by subcutaneous injection once Receives: Drug: Placebos

What is being measured

The primary outcome is the main question the study is designed to answer.

Preliminary Safety Assessment: Occurence of adverse events
Occurence of adverse events
Measured: 7 days follow-up

Secondary outcomes (2)

Volume of distribution of SP16 in healthy subjects
Population estimate of volume of distribution will be calculated using non-compartmental analysis
Measured: 7 days
Clearance of SP16 in healthy subjects
Population estimate of clearance will be calculated using non-compartmental analysis
Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Jul 201823 Jan 2019

First posted29 Aug 2018
Study start16 Jul 2018
Primary completion15 Jan 2019
Study completion23 Jan 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
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 blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03651089
Sponsor's protocol ID: 01-SP16
Status last verified: Jul 2021
First submitted: 27 Aug 2018
Last updated: 28 Jul 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: The investigators plan to present the data promptly upon analysis as an abstract to a national meeting and/or manuscript

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy Participants trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT03651089
Acronym / sponsor ID: 01-SP16
Conditions: Healthy Participants
Keywords: acute myocardial infarction, inflammation
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Serpin Pharma, LLCUniversity, hospital or other
Collaborators: George Mason University, Virginia Commonwealth University
Study start: 16 Jul 2018 (actual)
Primary completion: 15 Jan 2019 (actual)
Study completion: 23 Jan 2019 (actual)
First posted: 29 Aug 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4
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.

Arm	Type	Receives
SP16 0.0125	Active comparator	Drug: SP160.0125 mg/kg of SP16 will be administered by subcutaneous injection once
SP16 0.050	Active comparator	Drug: SP160.050 mg/kg of SP16 will be administered by subcutaneous injection once
SP16 0.20	Active comparator	Drug: SP160.20 mg/kg of SP16 will be administered by subcutaneous injection once
placebo	Placebo comparator	Drug: PlacebosPlacebo (sterile saline) will be administered by subcutaneous injection once

Who may qualify

Ages: 18 to 59 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (11 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SP16subcutaneous injection of experimental anti-inflammatory drug	Drug	SP16 0.0125, SP16 0.050, SP16 0.20
Placebossubcutaneous injection of sterile saline	Drug	placebo

Primary outcome

Preliminary Safety Assessment: Occurence of adverse events
Time frame: 7 days follow-up
Occurence of adverse events

2 secondary outcomes

Volume of distribution of SP16 in healthy subjects
Time frame: 7 days
Clearance of SP16 in healthy subjects
Time frame: 7 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
A phase 1 clinical trial of SP16, a first-in-class anti-inflammatory LRP1 agonist, in healthy volunteersLink provided by the sponsor.
Individual participant dataSharing planned: Yes. The investigators plan to present the data promptly upon analysis as an abstract to a national meeting and/or manuscript

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Antonio Abbate, MD, PhD principal investigator

Virginia Commonwealth University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SP16 in people with Healthy Participants, run by Serpin Pharma, LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Preliminary Safety Assessment: Occurence of adverse events (time frame: 7 days follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03651089.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.