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

Completed · Phase 1

Conditions studied: Depression

In brief

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

Key facts

Study ID

NCT01310881

Run by

Neuralstem Inc.

People needed

35

Starts

2011-02-01

Expected to finish

2011-11-01

Last updated by the study team

2011-11-21

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• A subject must meet all of the following criteria:
• Subject has the ability to understand the purpose and risks of the study and to provide signed and dated informed consent.
• Males and females between 18 to 55 years of age, inclusive, at the time of informed consent.
• 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).
• 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.
• 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.
• BMI ≥ 19.5 and ≤30.0 kg/m2, at screening. Bodyweight must be >50 kg.
• Healthy, determined by pre-study medical evaluation and investigator discretion (medical history, physical examination, vital signs, ECG, and clinical laboratory evaluations).

You may not qualify if…

• 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.
• History of seizures including febrile seizures, loss of consciousness, or any clinically significant finding on the neurologic examination.
• Clinically significant abnormal clinical chemistry values, as determined by the Investigator.
• 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.
• History of severe allergic or anaphylactic reactions.
• Subjects who have plans to undergo elective procedures/surgeries at any time during the study through the follow-up visits.
• 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).
• Serious infection (e.g. pneumonia, septicemia) as determined by the Investigator within 3 months prior to Day -1.
• Fever or bacterial, or viral infection (including upper respiratory tract infection) within 2 weeks prior to Day -1.
• Treatment with any prescribed medication within 28 days prior to Day -1.
• Treatment with any over-the-counter products (OTC), including herbal and/or alternative health preparations and procedures within the 14 days prior to Day -1. Note: Intermittent treatment with acetaminophen [≤1000 mg/day] and/or ibuprofen [≤400 mg/day] is permitted.
• Current enrollment in any other drug, biologic, device, or clinical study, or treatment with an investigational product or approved therapy for investigational use within 30 days (or 5 half-lives, whichever is longer) prior to Day -1.
• Any live or attenuated immunization/vaccination within 1 month prior to the study drug administration or planned to occur during the study period.
• Donation of blood (>500 mL) or blood products within 1 month prior to screening.
• History of alcohol or substance abuse (cocaine, amphetamines, barbiturates, opiates, benzodiazepines, cannabinoids, etc.) (as determined by the Investigator).
• Vigorous exercise (as determined by the Investigator) within 48 hours prior to the study drug administration.
• Inability to comply with study requirements.
• Any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs.
• Any concurrent disease or condition that, in the opinion of the Investigator, would make the subject unsuitable for participation in the clinical study.
• Subject unwilling to avoid consumption of coffee and caffeine containing beverages within 48 hours prior to Day -1 until discharge from the clinical site.
• Use of an investigational product within 30 days prior to Day -1.
• Subject is unable to understand the protocol requirements, instructions and study-related restrictions, the nature, scope and possible consequences of the clinical study.
• Subject is unlikely to comply with the protocol requirements, instructions and study-related restrictions.
• Subject has previously been enrolled in this clinical study.

Where it is running

• California Clinical Trials — Glendale, California, United States

Full record on ClinicalTrials.gov

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