Acute Ischemic StrokePhase 1NCT05547438

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

A Phase 1 study testing NTS-104 TRIS in people with Acute Ischemic Stroke, run by NeuroTrauma Sciences, LLC at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Acute Ischemic Stroke
What is being tested?: NTS-104 TRIS
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 48 participants
Where: 1 siteUnited States
Study dates: 1 May 2023to 8 Jan 2026
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

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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)

Who cannot join

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.

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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.
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

Trial locations and contacts

1 site in 1 country.

United States1 site

Parexel International EPCU Baltimore 7th floor
Baltimore, Maryland, 21225

Other trials in United States

About this study

Official title: A Single-Center, Randomized, Placebo-Controlled, Single Ascending Dose Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenous Nts-104 Tris in Healthy Adults

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.

Read the detailed description

This is a randomized, , placebo-controlled, Phase 1, single-dose, dose-escalation study to assess the safety, tolerability, and PK of IV NTS-104 in healthy participants. The study is composed of a screening period, a treatment day, and a follow-up period. The study will enroll 4 cohorts with 8 participants in each cohort. Participants in each cohort will be randomized 3:1 to receive either a single IV administration of NTS-104 or placebo. Cohort 1 will be administered 0.8 mg/kg (Cohort 1) with proposed subsequent doses of 4 mg/kg (Cohort 2), 8 mg/kg (Cohort 3), and 16 mg/kg (Cohort 4). Two additional cohorts of 8 participants each, Cohorts 5 and 6, may be enrolled if the human equivalent dose to the no-observed-adverse-effect level (NOAEL) dose in rats is not reached or if exposure limits are not exceeded in the first 4 cohorts. Each cohort will start with a sentinel pair of participants, with 1 participant assigned to NTS-104 Tris (Arm 1) and 1 participant randomized to placebo (Arm 2). If there are no safety concerns identified at 48 hours, the remainder of the cohort will be dosed, with 5 participants randomized to NTS-104 Tris (Arm 1) and 1 participant assigned to placebo (Arm 2).

Conditions: Acute Ischemic Stroke
Being tested: NTS-104 TRIS, Placebo
Medical subject headings: Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NTS-104 TRISDrug
Also called IP
Subjects will receive a single IV infusion of either 0.8, 4, 8, or 16 mg/mL NTS-104 depending on the Cohort number
PlaceboDrug
Also called Buffer
Subjects will be administered an IV infusion of placebo and the same duration and volume as the subjects administered NTS-104 TRIS in the cohort

Study groups in NCT05547438
Study group	Role	What they receive
Treatment Arm 1	Experimental	0.8, 4, 8, or 16 mg/mL NTS-104 solution for IV infusion Receives: Drug: NTS-104 TRIS
Treatment Arm 2	Placebo comparator	Single administration of placebo at the same volume and duration Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Adverse Events and Serious Adverse Events
Treatment emergent adverse events reported by the participant or observed by the Investigator
Measured: Day -28 to Day 8
Change from Baseline in Physical Examination
Any change in appearance, eyes, ears, nose, head, throat, neck, chest, lungs, heart, abdomen, extremities, skin, and neurologic examination including mental status from the screening physical to the physical on Day 8
Measured: Day -28 to Day 8
Change in Baseline Vital Signs
Any change in vital signs will include blood pressure and heart rate at supine position after the participant has sat quietly for at least 5 minutes, from screening to Day 8.
Measured: Day -28 to Day 8
Concomitant Medication Use
Change in use of concomitant medication taken from screening to after the IP administration
Measured: Day -1 to Day 8
Change in QTcF Determined by Electrocardiogram
Any change in the QTcF from screening determined significant by the Investigator.
Measured: Day -28 to Day 8

Secondary outcomes (8)

Cmax
Maximum plasma concentration calculated using non-compartmental analysis
Measured: Blood will be drawn from each patient prior to the start of the infusion, at 30, 60, 75, 90, 105, 120, 150, and 180 minutes after the infusion as well as at 4, 6, 8, 12, 24, 36, and 48 hours after the infusion.
Tmax
Time to reach maximum plasma concentration using non-compartmental analysis
Measured: Blood will be drawn from each patient prior to the start of the infusion, at 30, 60, 75, 90, 105, 120, 150, and 180 minutes after the infusion as well as at 4, 6, 8, 12, 24, 36, and 48 hours after the infusion.
AUC(0-t)
area under the curve to the last time with a concentration ≥ the lower limit of quantification of the bioanalytical method using non-compartmental analysis
Measured: Blood will be drawn from each patient prior to the start of the infusion, at 30, 60, 75, 90, 105, 120, 150, and 180 minutes after the infusion as well as at 4, 6, 8, 12, 24, 36, and 48 hours after the infusion.
AUC(inf)
Area under the curve to infinity using non-compartmental analysis
Measured: Blood will be drawn from each patient prior to the start of the infusion, at 30, 60, 75, 90, 105, 120, 150, and 180 minutes after the infusion as well as at 4, 6, 8, 12, 24, 36, and 48 hours after the infusion.
Elimination rate constant (λz)
Rate of elimination of IP using non-compartmental analysis based concentrations in plasma
Measured: Blood will be drawn from each patient prior to the start of the infusion, at 30, 60, 75, 90, 105, 120, 150, and 180 minutes after the infusion as well as at 4, 6, 8, 12, 24, 36, and 48 hours after the infusion.
Elimination half-life (t½)
The time it takes for the elimination processes to reduce the plasma concentration or the amount of drug in the body by 50 percent. Will be calculated using non-compartmental analysis based on the plasma concentrations
Measured: Blood will be drawn from each patient prior to the start of the infusion, at 30, 60, 75, 90, 105, 120, 150, and 180 minutes after the infusion as well as at 4, 6, 8, 12, 24, 36, and 48 hours after the infusion.
Total Plasma Clearance (CL)
Elimination of drug over time as determined by non-compartmental analysis of plasma concentrations
Measured: Blood will be drawn from each patient prior to the start of the infusion, at 30, 60, 75, 90, 105, 120, 150, and 180 minutes after the infusion as well as at 4, 6, 8, 12, 24, 36, and 48 hours after the infusion.
Volume of Distribution (Vz)
Proportionality constant that relates the total amount of drug in the body to the plasma concentration of the drug at a given time as determined by non-compartmental analysis of the plasma concentrations
Measured: Blood will be drawn from each patient prior to the start of the infusion, at 30, 60, 75, 90, 105, 120, 150, and 180 minutes after the infusion as well as at 4, 6, 8, 12, 24, 36, and 48 hours after the infusion.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 20238 Jan 2026

First posted21 Sep 2022
Study start1 May 2023
Primary completion18 Dec 2023
Study completion8 Jan 2026

Why it stopped: a second generation product was found to be more relevant for development

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Model description: Single ascending doses and Multiple ascending doses with review of safety, tolerability and pk prior to next dose level
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05547438
Sponsor's protocol ID: CLN-22-411
Status last verified: Jul 2026
First submitted: 12 Sep 2022
Last updated: 24 Jul 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Center, Randomized, Placebo-Controlled, Single Ascending Dose Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenous Nts-104 Tris in Healthy Adults
ClinicalTrials.gov ID: NCT05547438
Acronym / sponsor ID: CLN-22-411
Conditions: Acute Ischemic Stroke
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: a second generation product was found to be more relevant for development
Enrolment: 48 participants (actual)
Lead sponsor: NeuroTrauma Sciences, LLCIndustry (pharma, biotech, devices)
Collaborators: Parexel
Study start: 1 May 2023 (actual)
Primary completion: 18 Dec 2023 (actual)
Study completion: 8 Jan 2026 (actual)
First posted: 21 Sep 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Single ascending doses and Multiple ascending doses with review of safety, tolerability and pk prior to next dose level

Arm	Type	Receives
Treatment Arm 1	Experimental	Drug: NTS-104 TRIS0.8, 4, 8, or 16 mg/mL NTS-104 solution for IV infusion
Treatment Arm 2	Placebo comparator	Drug: PlaceboSingle administration of placebo at the same volume and duration

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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.

Key exclusion criteria (22 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NTS-104 TRISAlso: IPSubjects will receive a single IV infusion of either 0.8, 4, 8, or 16 mg/mL NTS-104 depending on the Cohort number	Drug	Treatment Arm 1
PlaceboAlso: BufferSubjects will be administered an IV infusion of placebo and the same duration and volume as the subjects administered NTS-104 TRIS in the cohort	Drug	Treatment Arm 2

Primary outcome

Adverse Events and Serious Adverse Events
Time frame: Day -28 to Day 8
Treatment emergent adverse events reported by the participant or observed by the Investigator
Change from Baseline in Physical Examination
Time frame: Day -28 to Day 8
Any change in appearance, eyes, ears, nose, head, throat, neck, chest, lungs, heart, abdomen, extremities, skin, and neurologic examination including mental status from the screening physical to the physical on Day 8
Change in Baseline Vital Signs
Time frame: Day -28 to Day 8
Any change in vital signs will include blood pressure and heart rate at supine position after the participant has sat quietly for at least 5 minutes, from screening to Day 8.
Concomitant Medication Use
Time frame: Day -1 to Day 8
Change in use of concomitant medication taken from screening to after the IP administration
Change in QTcF Determined by Electrocardiogram
Time frame: Day -28 to Day 8
Any change in the QTcF from screening determined significant by the Investigator.

8 secondary outcomes

Cmax
Time frame: Blood will be drawn from each patient prior to the start of the infusion, at 30, 60, 75, 90, 105, 120, 150, and 180 minutes after the infusion as well as at 4, 6, 8, 12, 24, 36, and 48 hours after the infusion.
Tmax
Time frame: Blood will be drawn from each patient prior to the start of the infusion, at 30, 60, 75, 90, 105, 120, 150, and 180 minutes after the infusion as well as at 4, 6, 8, 12, 24, 36, and 48 hours after the infusion.
AUC(0-t)
Time frame: Blood will be drawn from each patient prior to the start of the infusion, at 30, 60, 75, 90, 105, 120, 150, and 180 minutes after the infusion as well as at 4, 6, 8, 12, 24, 36, and 48 hours after the infusion.
AUC(inf)
Time frame: Blood will be drawn from each patient prior to the start of the infusion, at 30, 60, 75, 90, 105, 120, 150, and 180 minutes after the infusion as well as at 4, 6, 8, 12, 24, 36, and 48 hours after the infusion.
Elimination rate constant (λz)
Time frame: Blood will be drawn from each patient prior to the start of the infusion, at 30, 60, 75, 90, 105, 120, 150, and 180 minutes after the infusion as well as at 4, 6, 8, 12, 24, 36, and 48 hours after the infusion.
Elimination half-life (t½)
Time frame: Blood will be drawn from each patient prior to the start of the infusion, at 30, 60, 75, 90, 105, 120, 150, and 180 minutes after the infusion as well as at 4, 6, 8, 12, 24, 36, and 48 hours after the infusion.
Total Plasma Clearance (CL)
Time frame: Blood will be drawn from each patient prior to the start of the infusion, at 30, 60, 75, 90, 105, 120, 150, and 180 minutes after the infusion as well as at 4, 6, 8, 12, 24, 36, and 48 hours after the infusion.
Volume of Distribution (Vz)
Time frame: Blood will be drawn from each patient prior to the start of the infusion, at 30, 60, 75, 90, 105, 120, 150, and 180 minutes after the infusion as well as at 4, 6, 8, 12, 24, 36, and 48 hours after the infusion.

Results and safety

The study was stopped early (reason given: a second generation product was found to be more relevant for development). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marc de Somer, MD study director

NeuroTrauma Sciences, LLC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NTS-104 TRIS in people with Acute Ischemic Stroke, run by NeuroTrauma Sciences, LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: a second generation product was found to be more relevant for development). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events and Serious Adverse Events (time frame: Day -28 to Day 8). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05547438.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.