Study of TRX-100 Evaluating the Safety, Pharmacokinetics, and Food Effect in Healthy Volunteers

Inclusion Criteria: 1. Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects. 2. Adult males and females, 18 to 65 years of age (inclusive) at screening. 3. Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2, with a body weight (to 1 decimal place) ≥ 50.0 kg at screening. 4. Medically healthy without clinically significant abnormalities (in the opinion of the Investigator) at the screening visit, including: 1. Physical examination without any clinically significant findings in the opinion of the investigator. 2. Systolic blood pressure in the range of 90 mm Hg to 149 mm Hg; diastolic blood pressure in the range of 50 mm Hg to 90 mm Hg after 5 minutes in a supine or semi-supine position. 3. Heart rate (HR) in the range of 40 to 100 bpm after 5 minutes in a supine position 4. Body temperature (tympanic or oral) in the range 35.5°C to 37.5°C (inclusive). 5. No clinically significant findings in serum chemistry, hematology, coagulation, and urinalysis tests as judged by the Investigator, including the following specific findings: i. Haemoglobin, platelet count, WBC count, lymphocyte count, and neutrophil count within normal ranges (as per local laboratory standard ranges) or out-of-range values deemed not clinically significant (NCS) by the Investigator. ii. AST, ALT and total bilirubin \< 1.5 x ULN (note: for participants with Gilbert's syndrome, ULN for total bilirubin is considered to be 2.9 mg/dL). iii. Triplicate 12-lead ECG (taken after the volunteer has been supine for at least 5 minutes) with a QTcF ≤ 450 msec for males and ≤ 470 msec for females and no clinically significant abnormalities. iv. Hemoglobin A1C (HbA1c) level within the local laboratory standard reference range 5. Be willing to refrain from smoking (including tobacco, nicotine replacement therapy, e-cigarettes) from 7 days prior to dose administration on Day 1 to Day 12 (inclusive). 6. Be willing to abstain from alcohol consumption at least 48 hours prior to dosing on Day -1 and throughout the study. 7. Female volunteers must: 1. Be of nonchildbearing potential, i.e., surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy) at least 6 weeks before screening or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause and a follicle-stimulating hormone (FSH) level \>40 IU/L at the screening visit), or 2. If of childbearing potential, must: i. Have a negative pregnancy test at the screening visit and on admission to the clinic on Day-1. ii. Agree not to attempt to become pregnant or donate ova from signing the consent form until at least 30 days after the last dose of the study drug. iii. Agree to use adequate contraception (defined as use of a condom by the male partner combined with use of a highly effective method of contraception) from one month prior to screening until at least 30 days after the last dose of study drug, if not exclusively in a same-sex relationship or abstinent as a committed lifestyle. 8. Male volunteers must: 1. Agree not to donate sperm from signing the consent form until at least 90 days after the last dose of study drug. 2. If engaging in sexual intercourse with a female partner who could become pregnant, agree to use adequate contraception (defined as use of a condom combined with use of a highly effective method of contraception) from signing the consent form until at least 30 days after the last dose of study drug. 9. Have suitable venous access for blood sampling. 10. Be willing and able to comply with all study assessments and adhere to the protocol. Exclusion Criteria: 1. History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or major surgery within the past 3 months determined by the PI to be clinically significant. 2. History of surgery or hospitalisation within 30 days prior to screening, or surgery planned during the study. 3. Acute infections within 4 weeks prior to screening or current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medications. 4. Presence or history of any abnormality or illness, including gastrointestinal surgery, liver, kidney, or other conditions, which in the opinion of the PI may affect absorption, distribution, metabolism or elimination of the study drug. 5. Any history of malignant disease in the last 5 years (excludes surgically resected skin squamous cell or basal cell carcinoma). 6. Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia. 7. Use of or plans to use systemic immunosuppressive (e.g., corticosteroids by any route, methotrexate, azathioprine, cyclosporine) or immunomodulating medications (e.g., interferon) during the study and within 5 half-lives of individual agent or within 28 days (whichever is longer) prior to dosing. 8. Use of or plans to use agents (e.g., grapefruit and grapefruit products) that have clinically significant interaction with CYP3A4 or the use of any medications that could have a significantly impact on organ function (e.g., barbiturates, omeprazole, cimetidine) during the study and within 5 half-lives of individual agent or within 7 days (whichever is longer) prior to dosing. 9. History of risk factors for torsade de pointes (including a family history of long QT syndrome or sudden cardiac death) or clinically significant arrythmia. 10. Positive test results for active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies at the screening visit. 11. Estimated creatinine clearance \< 6