Single Ascending Dose Safety and Tolerability of NTS-104 Healthy Adults

• Status: Not yet recruiting
• Trial end date: 2023-05-21
• Target enrollment: 0
• Participant gender: All

Summary

NTS-104 TRIS will be administered as a single intravenous dose to healthy subjects at doses of 0.8, 4, 8 and 16 mg/kg in 4 Cohorts. Each cohort of 8 subjects will begin with dosing 2 sentinel subjects with one being given the investigational product and one the placebo. If no safety issues arise, dosing the remaining subjects in the cohort will begin. A Safety Review Committee will review the safety and pharmacokinetic data before approving escalation to the next dose level.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: NeuroTrauma Sciences, LLC
• Collaborator: Parexel

Criteria

Inclusion Criteria:

1. Participants who provide written informed consent to participate in the study.

2. Healthy males and females between 18 and 65 years (inclusive) of age at the time of signing informed consent.

3. Body mass index (BMI) of 18 to 32 kg/m2 (inclusive) and weighing at least 50 kg at screening.

4. Participants in general good health in the opinion of the Investigator as determined by medical history; vital signs; and physical, neurological, and suicidal ideation examinations.

5. Blood pressure and heart rate within normal limits (blood pressure: systolic 90 to 140 mmHg and diastolic 50 to 90 mmHg; heart rate: 45 to 100 beats per minute) at screening and at admission on Day -1.

6. Female participants must have a negative serum pregnancy test at screening and at admission and be willing and able to use a medically acceptable method of birth control during the trial and 4 weeks afterward or be postmenopausal.

Acceptable methods of birth control in this study include abstinence, tubal ligation, tubal occlusion, consistent use of an approved oral contraceptive (birth control pill or "the pill"), intrauterine device (IUD), hormonal implants, contraceptive injection, or a double barrier method (diaphragm with spermicidal gel or condom with contraceptive foam). Postmenopausal women are defined as females with menstruation cessation for 12 consecutive months prior to signing of the ICF.

7. Male participants with a partner who might become pregnant must use reliable forms of contraception during the trial and 4 weeks afterward, i.e., vasectomy or by the partner oral contraceptive (birth control pill or "the pill"), IUD, hormonal implants, contraceptive injection, or a double barrier method.-

Exclusion Criteria:

History of significant medical disorder that, in the opinion of the Investigator, contraindicates administration of the study medications.

2. History or current diagnosis of hepatic impairment. 3. History or current diagnosis of renal impairment. Protocol CLN-22-4111 28 4. Positive neurological examination. 5. Positive C-SSRS. 6. Diabetes mellitus type 1 or history of diabetes mellitus type 2. 7. Any clinically significant abnormality in safety laboratory tests at screening or admission.

8. Any acute illness (e.g., acute infection) within 72 hours of study drug administration, which is considered of significance by the Investigator.

9. Any history of seizures or epilepsy. 10. Participation in another clinical trial with drugs received within 30 days or 5 half-lives (whichever is longer) prior to dosing (calculated from the previous study's last dosing date).

11. Participants should not have taken medications for at least 30 days prior to enrollment.

12. Active smoker and/or has smoked or used nicotine or nicotine-containing products (e.g., nicotine patch, gum, e-cigarettes) within the past 6 months before enrollment.

13. The use of ketogenic diets within 12 months prior to enrollment. 14. Positive serum pregnancy test determined during screening and/or admission or currently lactating women.

15. ECG with clinically significant finding recorded at screening or admission. 16. Positive human immunodeficiency virus (HIV), hepatitis B, or hepatitis C serology at screening.

17. Positive coronavirus disease 2019 (COVID-19) test determined at screening and admission (nasal swab).

18. Known history of alcohol or drug abuse in the past 5 years. 19. Positive urinary drug or cotinine screen determined at screening and admission.

20. Positive serum alcohol screen determined during the screening period and on admission.

21. Any other condition, which in the Investigator's opinion, would not make the participant a good candidate for the study.

22. Blood donation of 500 mL (1 pint) or more: 56 days before the screening visit and until after the follow-up visit.

23. Plasma donation: 7 days before the screening visit and until after the follow-up visit.

24. Grapefruit, grapefruit juice, star fruit, pomegranate, and Seville oranges: 7 days before screening and until after the follow-up visit