SP16 SERPIN-like Peptide Administration in Healthy Individuals
Completed · Phase 1 · Has a placebo group
Conditions studied: Healthy Participants
In brief
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.
Key facts
- Study ID
- NCT03651089
- Run by
- Serpin Pharma, LLC
- People needed
- 24
- Starts
- 2018-07-16
- Expected to finish
- 2019-01-23
- Last updated by the study team
- 2021-07-28
Who can join
Age: 18 and older, up to 59. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Virginia Commonwealth University — Richmond, Virginia, United States
Full record on ClinicalTrials.gov
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