A First-in-Human Phase 1 Study of Plasmalogen Precursor PPI-1011 in Healthy Adult Volunteers to Assess Safety, Tolerability, and Pharmacokinetics

Inclusion Criteria:

1. Healthy, non-smoking (for at least 6 months prior to first study drug administration)male, and non-pregnant and non-lactating female (including post-menopausal andsurgically sterile female) volunteers, 18-65 years of age, inclusive at the time ofinformed consent.

• Post-menopausal for at least 1 year [confirmed by FSH (16-157 IU/L) and 17β-estradiol (<202 pmol/L) levels]
• Surgically sterile (Partial or total hysterectomy, bilateral oophorectomy,bilateral salpingo-oophorectomy) for at least 6 months [confirmed bymedical/operative report or if medical/operative report is not available byFSH and 17β-estradiol tests, if applicable].

2. Body mass index (BMI) that is within 18.5 - 30.0 kg/m2, inclusive, and subject weighsno more than 91.0 kg.
3. Healthy, according to the medical history, ECG, vital signs, laboratory results andphysical examination as determined by the PI/Sub-Investigator.
4. Systolic blood pressure between 95-140 mmHg, inclusive, and diastolic blood pressurebetween 55-90 mmHg, inclusive, oxygen saturation level between 95% and 100%,inclusive, and heart rate between 55-100 bpm, inclusive, unless deemed otherwise bythe PI/Sub-Investigator.
5. Clinical laboratory values within BPSI's most recent acceptable laboratory test range,and/or values are deemed by the PI/Sub-Investigator as "Not Clinically Significant".
6. Ability to comprehend and be informed of the nature of the study, as assessed by BPSIstaff. Capable of giving written informed consent prior to any study relatedprocedure. Must be able to communicate effectively with clinic staff.
7. Ability to fast for at least 10 hours and consume standard meals.
8. Availability to volunteer for the entire study duration and willing to adhere to allprotocol requirements.
9. Agree not to have a tattoo or body piercing until the end of the study.
10. Agree not to receive COVD-19 vaccination from 7 days prior to first study drugadministration until 7 days after the last study drug administration or the lastprocedure in the study, whichever is later.
11. Agree not to receive a vaccination (live attenuated vaccine) during the study anduntil 60 days after the study has ended (last study procedure)
12. Female subjects must be non-pregnant and non-lactating and fulfil at least one of thefollowing:

• Be surgically sterile for a minimum of 6 months (achieved through partial ortotal hysterectomy, bilateral oophorectomy, or bilateral salpingectomy; note thattubal ligation is not considered a method of permanent sterilization).
• Post-menopausal for a minimum of 1 year [confirmed by FSH (16-157 IU/L) and 17β-estradiol (<202 pmol/L) levels]) (post-menopausal is defined as 12consecutive months with no menses without an alternative medical cause).
• Agree to avoid pregnancy and use an acceptable highly effective method ofcontraception with male sexual partners from at least 30 days prior to the studyuntil at least 30 days after the study has ended (last study procedure). Medically acceptable methods of contraception include oral contraceptives, hormonalpatch, implant or injection, hormonal or non-hormonal intrauterine device (IUD)combined with a barrier method (male or female condom, diaphragm with spermicide, orcervical cap with spermicide) or double barrier methods (male condom in conjunctionwith diaphragm and spermicide, male condom in conjunction with cervical cap andspermicide). Complete abstinence as a method of contraception is acceptable if it isin line with the preferred and usual lifestyle of the subject. If a subject becomes pregnant during her participation in the study and for 30 daysafter she has completed her last study study procedure, she must inform BPSI staffimmediately.

13. Males who are not vasectomized for at least 6 months prior to dosing and are able tofather children must agree to use an acceptable highly effective method ofcontraception with female sexual partners of childbearing potential and not donatesperm during the study and for at least 30 days after the last study drugadministration. Medically acceptable methods of contraception include using a condom with a female sexualpartner of childbearing potential who is using oral contraceptives, hormonal patch, implantor injection, IUD or system, or diaphragm with spermicide. Complete abstinence as a methodof contraception is acceptable if it is in line with the preferred and usual lifestyle ofthe subject. If a subject's partner becomes pregnant during his participation in the study and for 30days after he has completed his last study drug administration, he must inform BPSI staffimmediately.

Exclusion Criteria:

1. Known history or presence of any clinically significant hepatic, renal/genitourinary,gastrointestinal, cardiovascular, cerebrovascular, pulmonary, endocrine,immunological, musculoskeletal, neurological, psychiatric, dermatological orhematological disease or condition unless determined as not clinically significant bythe PI/Sub-Investigator.
2. Clinically significant history or presence of any clinically significantgastrointestinal pathology (e.g., chronic diarrhea, inflammatory bowel disease),unresolved gastrointestinal symptoms (e.g., diarrhea, vomiting), or other conditionsknown to interfere with the absorption, distribution, metabolism or excretion of thedrug experienced within 7 days prior to first study drug administration, as determinedby the PI/Sub-Investigator.
3. Presence of any clinically significant illness within 30 days prior to first dosing,as determined by the PI/Sub-Investigator.
4. Presence of any significant physical or organ abnormality as determined by thePI/Sub-Investigator.
5. A known history or positive test result for human immunodeficiency virus (HIV),chronic Hepatitis B surface antigen, or Hepatitis C.
6. A positive test result for drugs of abuse/recreational drugs (marijuana, amphetamines,barbiturates, cocaine, opiates, phencyclidine and benzodiazepines), alcohol test andcotinine. Positive pregnancy test for female subjects of childbearing potential.
7. Known history or presence of:

• Alcohol abuse or dependence within one year prior to first study drugadministration;
• Drug abuse or dependence;
• Known hypersensitivity or idiosyncratic reaction to PPI-1011, its excipients (e.g., liquid coconut oil, 1-thioglycerol etc), and/or related substances;
• Food allergies;
• Presence of any dietary restrictions unless deemed by the PI/Sub-Investigator as "Not Clinically Significant";
• Severe allergic reactions (e.g. anaphylactic reactions, angioedema).
• Intolerance to and/or difficulty with blood sampling through venipuncture.
• Abnormal diet patterns (for any reason) during the four weeks preceding thestudy, including fasting, high protein diets etc.

10. Individuals who have donated, in the days prior to first study drug administration:

• 50-499 mL of blood in the previous 30 days;
• 500 mL or more in the previous 56 days. 11. Donation of plasma by plasmapheresiswithin 7 days prior to first study drug administration.

12. Individuals who have participated in another clinical trial or who received aninvestigational drug within 30 days prior to first study drug administration.
13. Use of any lipid lowering drug/agent including hydroxymethylglutaryl (HMG) CoAreductase inhibitors (Statins), cholesterol absorbing inhibitors (Ezetimibe), fibricacid derivatives (Fibrates), bile acid sequestrants, PCSK9 inhibitors, and nicotinicacid within 30 days prior to first study drug administration and for the duration ofthe study.
14. Use of of any supplements containing DHA, fish oil, krill oil, plasmalogen extractor scallop extracts within 30 days prior to first study drug administration and forthe duration of the study.
15. Use of any supplements containing lipoic acid within 30 days prior to first studydrug administration and for the duration of the study.
16. Use of any prescription medication within 14 days prior to first study drugadministration (except for accepted methods of contraception).
17. Use of any over-the-counter medications (including oral multivitamins, herbaland/or dietary supplements) within 14 days prior to first study drug administration (except for accepted methods of contraception).
18. Consumption of food or beverages containing grapefruit and/or pomelo within 10days prior to first study drug administration.
19. Consumption of food or beverages containing caffeine/methylxanthines, poppy seedsand/or alcohol within 48 hours before dosing.
20. Individuals having undergone any major surgery within 6 months prior to the startof the study, unless deemed otherwise by PI/Sub-Investigator.
21. Have any other conditions that, in the opinion of the Investigator or Sponsor,would make the subject unsuitable for inclusion, or could interfere with the subjectparticipating in or completing the study.
22. Difficulty with swallowing the study drug (oral solution). 23. Have tonguepiercings and/or mouth jewelry. 24. Women who are pregnant or lactating. 25. Unable orunwilling to provide informed consent 26. Have had a tattoo or body piercing within 30days prior to first study drug administration.