Safety and pharmacokinetics in healthy volunteers Other
Conditions
Interventions
The study uses a dose escalation design and seven sequential dosing cohorts are included.
Participants will be randomized using a computer-generated schedule to receive either HI-6 Dimethanesulfonat
Sponsors
Department of National Defence
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 19/02/2026: 1. Healthy volunteers between 18 and 50 years inclusive, at the time of signing the informed consent. 2. Women of childbearing potential (WOCBP) and male participants with partners of childbearing potential must agree to use highly effective methods of contraception (described below) for at least 30 days (1 month) before trial intervention administration and for (1) month after completion of trial intervention administration. WOCBP are defined as females who have not been surgically sterilized or who are not postmenopausal. A woman is considered not of childbearing potential if she meets the following criteria: • Has been postmenopausal for at least 12 consecutive months prior to study drug administration • Has undergone surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy) at least 6 months prior to study drug administration, or • Has medically documented ovarian failure The following are adequate methods of contraception: • The consistent use of an approved hormonal contraception (birth control pill/patches, rings) • An intrauterine device (IUD) • Contraceptive injection (Depo-Provera) • Double barrier methods (Diaphragm with spermicidal gel or condoms with contraceptive foam) • Sexual abstinence (no sexual intercourse) or • Sterilization 3. Non-surgically sterile male participants or male participants with female partners of childbearing potential (including pregnant or breastfeeding) must use a highly effective method of contraception during the study and for one (1) month after completion of trial intervention administration, or ensure that their partner(s) will use a highly effective method of contraception for the same time duration. Male participants must use a condom and spermicide and the adequate methods of contraception for their female partners of childbearing potential are described above. 4. WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction for one (1) month after completion of trial intervention administration. 5. Male participants must be willing to refrain from sperm donation for one (1) month after completion of trial intervention administration. 6. BMI range of 18.0 - 30.0 kg/m2. 7. Findings within the range of clinical acceptability in medical history, physical examination, 12-lead ECG, vital signs, and laboratory results within the “normal ranges” for the relevant laboratory tests (unless the investigator considers the deviation to be irrelevant for the purpose of the study). 8. Non-smoking (i.e., having no history of tobacco, or other substance or no smoking for greater than or equal to 12 months and not having smoked within the past year by self-report). 9. Negative for hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus (HIV), and tuberculosis at screening. 10. Negative urine screen for drugs of abuse and negative urine cotinine test to confirm absence of recent tobacco use. 11. Breath alcohol concentration no greater than 0.0%. 12. Able to understand the requirements of the study and sign Informed Consent Form (ICF). Previous inclusion criteria: 1. Healthy volunteers between 18 and 50 years inclusive, at the time of signing the informed consent. 2. Women of childbearing potential (WOCBP) and male participants with partners of childbearing potential must agree to use highly effective methods of contraception (described below) for (1) month after completion o
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 19/02/2026: 1. Any condition or therapy that, in the opinion of the investigator, may be significantly worsened by the administration of HI-6 DMS or is likely to interfere with the successful collection of the measures required. 2. Clinically significant illnesses or surgery within 4 weeks prior to trial intervention administration. 3. Any clinically significant history or presence of clinically significant neurological, endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric, or metabolic disease or any medical history or condition associated with impaired cyanide detoxification or sulfurtransferase (rhodanese, thiosulfate sulfurtransferase) activity (e.g., history of hypersensitivity or adverse reaction to cyanide or cyanide-releasing compounds such as nitroprusside, Leber's Hereditary Optic Neuropathy), as determined by the investigator. 4. Any known impairment in renal drug clearance, including but not limited to reduced estimated glomerular filtration rate (eGFR) below 90 ml/min/1.73 m2 (National Kidney Foundation, 2022), tubular dysfunction, or genetic polymorphisms affecting renal transporters (e.g., MATE1, MATE2-K). 5. Currently taking medications known to significantly induce or inhibit renal drug elimination pathways, such as cimetidine. 6. Blood urea nitrogen (BUN) or serum creatinine (sCr) outside of normal range, or any other abnormal laboratory tests judged by the investigator to be clinically significant. 7. Positive testing for hepatitis B, hepatitis C, HIV, or tuberculosis at screening. 8. ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure that remains lower than 90 or over 140 mmHg, diastolic blood pressure that remains lower than 50 or over 90 mmHg, or heart rate that remains lower than 50 or over 100 bpm) at screening. 9. History of allergic reactions to heparin or other related drugs. 10. Cancer within the previous 5 years, other than squamous cell or basal cell carcinoma of the skin. 11. History of serious adverse reaction or hypersensitivity to any drug. 12. Known prolonged bleeding times resulting from disease or ongoing regimen use of anticoagulant medication (e.g., warfarin). If participants are on a drug or supplement that prolongs bleeding times (e.g., non-steroidal anti-inflammatory, anticoagulant, high dose vitamin E, fish oil, corticosteroids), they must discontinue use at least 7 days prior to trial intervention. Warfarin use is not permitted within this 14-day window before or after trial intervention administration. 13. Donation of plasma (500 ml) within 7 days prior to trial intervention administration. Donation or loss of whole blood (excluding the volume of blood that will be drawn during the screening procedures of this study) permitted prior to trial intervention administration as follows: 50 ml to 300 ml of whole blood within 30 days, 301 ml to 500 ml of whole blood within 45 days, or more than 500 ml of whole blood within 56 days prior to trial intervention administration. 14. Any known or suspected allergy to any constituent of HI-6 DMS. 15. Any food allergy, intolerance, restriction or special diet that, in the opinion of the investigator, could contraindicate the participant’s participation in this study. 16. A depot injection or an implant of any drug within 3 months prior to trial intervention administration (contraceptive injections/implants are exempted). 17. Use of any drugs known to induc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety is measured using the following assessments at specified timepoints between study entry (-10 hours, Evening Prior to Dosing) to 48 hours 15 minutes after the start of dosing: 1.Frequency, severity, and type of adverse events (including infusion site reactions and predefined dose-limiting toxicities) 2.Clinically significant changes in laboratory parameters (hematology, biochemistry, and urinalysis) 3.Vital signs (heart rate, blood pressure, venous oxygen saturation, body temperature, respiratory rate) 4.Electrocardiogram findings and physical examinations | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters are measured by analyzing HI-6 DMS in plasma and urine samples at specified timepoints between 1 hour before dosing to 48 hours 15 minutes after the start of dosing. | — |
Countries
Canada
Contacts
Public ContactMo Hashi
Outcome results
None listed