First-in-Human Trial in Healthy Adult Volunteers to Evaluate Safety, Tolerability and PK of LAPIX Study Drug; LPX-TI641

Inclusion Criteria: Healthy volunteers

1. Subject has signed an Informed Consent Form (ICF) prior to any study-specificprocedures being performed

2. Healthy volunteers (HV) with no known acute or chronic medical conditions (respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic,neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary,endocrine, etc.) at the time of enrollment.

3. Healthy volunteers (HV) with dermatological conditions are allowed if they are notreceiving systemic treatments for their dermatological condition.

4. All male and non-pregnant females aged 18-55 years old irrespective of their raceand ethnicity.

5. Body Mass Index (BMI) 18.0-30.0 kg/m2, inclusive at screening.

6. Clinical laboratory evaluations performed at screening, are within acceptable normalreference ranges (Grade 1 abnormalities may be acceptable if deemed necessary by theinvestigator. Grade 2 or higher would be exclusionary).

7. Subjects who are willing and able to adhere to study protocol requirements includingbut not limited to scheduled outpatient visits, inpatient hospital stay, laboratorytests, and 12-lead ECG.

8. Contraception - All subjects (male and female) must agree to use any two of thehighly effective contraception methods listed below. This criterion must be followedfrom the time of the first dose of study medication for 6 weeks after the last dosein females and for 90 days after the last dose for males. a. The following applies to all female volunteers with childbearing potential andfemale partners of male volunteers enrolled in the study. i. Implantable progestogen-only hormone contraception associated with inhibition ofovulation.

ii. Intrauterine device. iii. Intrauterine hormone-releasing system. iv. Bilateral tubal occlusion. v. Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation: 1) Oral 2) Intravaginal 3)Transdermal 4) Injectable vi. Progestogen-only hormone contraception (oral or injectable) is associated with inhibition of ovulation.

vii. Vasectomized partner viii. Sexual abstinence -this is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study intervention. The reliability of sexual abstinence needs to be evaluated about the duration of the study and the preferred and usual lifestyle of the participant.

b. The following applies to all male subjects in the study: i. Sexual abstinence- this is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study intervention. The reliability of sexual abstinence needs to be evaluated for the duration of the study and the preferred and usual lifestyle of the participant.

ii. A combination of male condoms with either cervical cap, diaphragm, or sponge with spermicide (double-barrier methods).

iii. Vasectomy

Exclusion Criteria: Healthy volunteers

1. Any known history of malignancy

2. Any known history of asthma

3. COVID-19: The subject has COVID-19 positive status (confirmed by clinical signs and symptomsand a positive SARS-CoV-2 NAAT result COVID test) at any time during the screeningperiod. OR has had recent COVID-19 vaccination including a booster dose in the past 30 days OR has received anti-viral therapy intended to prevent COVID-19 such asnelmetavir/ritonavir, remdesivir, molnupiravir, interferons, Anti-SARS-CoV-2monoclonal antibodies, IVIG SARS-CoV-2, COVID-19 Convalescent plasma, etc. withinthe past 30 days

4. Subject with positive results for HBsAg (hepatitis B surface antigens) and/or HBcAb (Hepatitis B core antibodies) and/or HCV Ab (hepatitis C antibodies), and/or HIV Ab (human immunodeficiency virus antibodies).

5. Blood loss of >250 mL or donated blood within 56 days or donated plasma within 7days of screening.

6. Recent vaccination with live attenuated vaccines such as influenza, MMR, Herpeszoster, varicella, yellow fever, Rotavirus vaccine, etc., or inactivated vaccinessuch as Hepatitis A, Rabies vaccine, etc. in the past 30 days.

7. Abnormal amylase levels (Grade 2 or greater)

8. Clinically significant ECG abnormalities (QTcF >450 ms for males and QTcF >470 msfor females).

9. History of or current compulsive abuse of alcohol or positive test for alcohol atscreening or Day 0 of Visit 1

10. History of or current use of or positive test at screening or Day 0 of Visit 1 fordrugs such as marijuana, cocaine, phencyclidine [PCP], crack, opioid derivativesincluding heroin, and amphetamine derivatives.

11. Consumption of any beverages or food containing alcohol or drugs such as marijuana,cocaine, phencyclidine [PCP], crack, opioid derivatives including heroin, andamphetamine derivatives from screening until donating the last sample of the study

12. Use of medications for the timeframes specified below, except for medicationsexempted by the Investigator on a case-by-case basis because they are judgedunlikely to affect the PK profile of the study drug or subject safety (e.g., topicaldrug products without significant systemic absorption):

• prescription medications within 14 days prior to dosing or 5 half-lives,whichever is longer;

• over-the-counter products and natural health products (including herbalremedies homeopathic and traditional medicines, probiotics, food supplementssuch as vitamins, minerals, amino acids, essential fatty acids, and proteinsupplements used in sports) within 14 days prior to dosing or 5 half-lives,whichever is longer, except for the occasional use of paracetamol (up to 2 gdaily);

• any prescription or over-the-counter medication or natural health products usedfor the treatment of irregular bowel transit (e.g,. diarrhea, constipation)within 4 weeks prior to dosing;

• depot injection or implant of any drug within 3 months prior to dosing;

• use of any drugs known to induce or inhibit hepatic metabolism (including St.John's Wort [hypericin]) within 14 days prior to dosing.

13. The subject has participated in another investigational study involving anyinvestigational product within 60 days, or 5 half-lives, whichever is longer, beforethe dose of the study drug.

14. Pregnant or lactating women or women currently undergoing infertility treatments orwomen who intend to become pregnant during the time of study enrollment.

15. Involvement in the planning and conduct of the study (applies to CRO staff or staffat the study site).