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

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Acute Ischemic Stroke

In brief

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.

Key facts

Study ID

NCT05547438

Run by

NeuroTrauma Sciences, LLC

People needed

48

Starts

2023-05-01

Expected to finish

2026-01-08

Last updated by the study team

2026-07-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Participants who provide written informed consent to participate in the study.
• Healthy males and females between 18 and 65 years (inclusive) of age at the time of signing informed consent.
• Body mass index (BMI) of 18 to 32 kg/m2 (inclusive) and weighing at least 50 kg at screening.
• 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.
• 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.
• 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 - Acceptable methods of birth control in this study must start one complete menstrual cycle (and at least 30 days) prior to the first day of dosing and continue until 4 weeks after the final follow-up visit.
• Acceptable methods of birth control include abstinence, tubal ligation, bilateral tubal occlusion, progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable and implantable), combined hormonal contraception (i.e., estrogen- and progestogen-containing), IUS and IUD.
• Female participants of non-childbearing potential are defined as either postmenopausal (evidence of menopause based on a combination of amenorrhea for at least one year confirmed with pre-admission serum follicle-stimulating hormone level [>30 IU/L]), or surgical sterilization (evidence of hysterectomy and/or bilateral oophorectomy).
• Male participants with a partner who might become pregnant must use reliable forms of contraception during the trial and 4 weeks afterward. Surgical sterilization (vasectomy with documentation of azoospermia) and a barrier method (condom).
• The participant's female partner uses oral contraceptives (combined hormonal contraception), injectable progesterone or subdermal implants, and the male partner uses a barrier method (condom)

You may not qualify if…

• History of significant medical disorder that, in the opinion of the Investigator, contraindicates administration of the study medications.
• Any active or current comorbidity with the exception of topical or allergic conditions treated with topical comedication and/or non-drowsy anti-allergic medication or acetaminophen
• Any use of current comedication at admission or during the 30 days prior to enrollment with the exception of topical dermatological medication and/or non-drowsy anti-allergic medication or acetaminophen
• Any acute illness (e.g., acute infection) within 72 hours of study drug administration, if considered of significance by the Investigator.
• Any clinically significant abnormality in safety laboratory tests at screening or admission, in particular a screening TSH test
• Positive human immunodeficiency virus, hepatitis B, or hepatitis C serology at screening.
• Specifically, any history or current diagnosis of hepatic impairment at screening and Day - 1
• Specifically, any history or current diagnosis of renal impairment at screening
• Specifically, a history of type 1 diabetes mellitus or current type 2 diabetes.
• Any abnormality on the neurological examination, at screening or enrollment
• Positive Columbia-Suicide Severity Rating Scale (C-SSRS).
• Participation in another clinical trial with drugs received within 3 months prior to dosing (calculated from the previous study's last dosing date).
• Participant who is an 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.
• The use of ketogenic diets within 12 months prior to enrollment.
• Electrocardiogram (ECG) with clinically significant findings recorded at screening or admission.
• Positive coronavirus disease 2019 (COVID-19) test determined at screening and admission (nasal swab).
• Known history of alcohol or drug abuse in the past 5 years. 19. Positive urinary drug or cotinine screen determined at screening and admission.
• Positive serum alcohol screen determined during the screening period and on admission.
• Any other condition, which in the Investigator's opinion, would not make the participant a good candidate for the study.
• Blood donation of 500 mL (1 pint) or more: 56 days before the screening visit and until after the follow-up visit.
• Plasma donation: 7 days before the screening visit and until after the follow-up visit.
• Grapefruit, grapefruit juice, star fruit, pomegranate, and Seville oranges: 7 days before screening and until after the follow-up visit

Where it is running

• Parexel International EPCU Baltimore 7th floor — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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