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Single-Dose Pharmacokinetics (PK) Study of Novel Neurogenic Compound NSI-189 | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Single-Dose Pharmacokinetics (PK) Study of Novel Neurogenic Compound NSI-189

A Phase 1, Randomized, Subject Single Blinded, Placebo-Controlled, Single-Dose Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics (PK) of NSI-189 Phosphate in Healthy Subjects

NCT01310881•Neuralstem Inc.

View on ClinicalTrials.gov

Summary

This is a subject single blinded, randomized, placebo-controlled, single dose, first-time-in-human study with three or more ascending cohorts.

Detailed Description

Each subject will undergo Screening (Day -28 to Day -2). Subjects will return to the clinical site on Day -1, be admitted to the unit, and eligibility will be reconfirmed. Eligible subjects will receive a single dose of investigational medicinal product (IMP, NSI-189 Phosphate or Placebo) on Day 1 and will be followed for safety and PK until discharge on Day 3. Subjects who are experiencing any significant AEs that are considered possibly related to study drug will be kept at the unit for an additional day (or longer) until the event resolves or it is considered medically safe for the subject to be discharged. Subjects will have a telephone Follow-up on Day 4 and return to the unit on Day 7 (± 1) for End-of-study. Participation of an individual subject may last up to 36 days from the time of Screening until the End-of-study.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•A subject must meet all of the following criteria:
•1. Subject has the ability to understand the purpose and risks of the study and to provide signed and dated informed consent.
•2. Males and females between 18 to 55 years of age, inclusive, at the time of informed consent.
•3. The following applies to female subjects:
•• Non-childbearing potential (surgically sterile \[hysterectomy or bilateral tubal ligation\] or post-menopausal ≥ 1 year with follicle stimulating hormone \>40 U/L).
•4. The following applies to male subjects:
•• Male subjects with a female partner of childbearing potential will be required to use an effective method of birth control or practice abstinence during this study and for 3 months following discontinuation of IMP.
•5. Non-smokers (or other nicotine use) as determined by history (no nicotine use over the past year) and by negative urine cotinine test at screening and Day -1.
•6. BMI ≥ 19.5 and ≤30.0 kg/m2, at screening. Bodyweight must be \>50 kg.
•7. Healthy, determined by pre-study medical evaluation and investigator discretion (medical history, physical examination, vital signs, ECG, and clinical laboratory evaluations).

Exclusion Criteria

•1. Clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, dermatological or psychiatric disorder(s), or other major disease as determined by the Investigator or designee.
•2. History of seizures including febrile seizures, loss of consciousness, or any clinically significant finding on the neurologic examination.
•3. Clinically significant abnormal clinical chemistry values, as determined by the Investigator.
•4. Clinically significant (as determined by the Investigator) 12-lead ECG abnormalities, including corrected QT interval using Bazett's correction method of \>450 msec for males and \>470 msec for females.
•5. History of severe allergic or anaphylactic reactions.
•6. Subjects who have plans to undergo elective procedures/surgeries at any time during the study through the follow-up visits.
•7. A positive screening test for human immunodeficiency virus (HIV), hepatitis C virus antibody (HCVAb), hepatitis B core antibody (HBcAb), or hepatitis B surface antigen (HBsAg).
•8. Serious infection (e.g. pneumonia, septicemia) as determined by the Investigator within 3 months prior to Day -1.
•9. Fever or bacterial, or viral infection (including upper respiratory tract infection) within 2 weeks prior to Day -1.
•10. Treatment with any prescribed medication within 28 days prior to Day -1.
+14 more criteria

Locations (1)

California Clinical Trials

Glendale, California, United States

Key Dates

Start Date

February 1, 2011

Primary Completion Date

November 1, 2011

Completion Date

November 1, 2011

Last Updated

November 21, 2011

Enrollment

ACTUAL participants

Conditions

Depression

Interventions

NSI-189 Phosphate

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 21, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Single-Dose Pharmacokinetics (PK) Study of Novel Neurogenic Compound NSI-189

Inclusion Criteria

Exclusion Criteria

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