Overview

Safety and Tolerability of NTRX-07 in Healthy Volunteers

Status:
Active, not recruiting
Trial end date:
2020-06-30
Target enrollment:
0
Participant gender:
All
Summary
Randomized, placebo-controlled, modified parallel-design single ascending dose (SAD) in adult healthy volunteers (HVs).
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
NeuroTherapia, Inc.
Collaborators:
Integrium
Orange County Research Center
Criteria
Inclusion Criteria:

- • Written, informed consent.

- Adult healthy male or females, ages 18-60 years, inclusive, who are surgically
sterilized (including hysterectomy and/or bilateral oophorectomy but not tubal
ligation) or naturally postmenopausal (2 without menses and documented blood
follicle-stimulating hormone ≥40 MIU/mL).

years

- Good health as determined by medical history, physical examination, vital signs, ECG,
and clinical laboratory measurements.

- Clinical laboratories within normal limits at screening (including blood glucose).

- Body mass index (BMI) of 18-35 kg/m 2 inclusive with body weight

>50 kg.

• Able to comply with the study regimen.

Exclusion Criteria:

- Any acute or chronic illness.

- Pregnant or lactating females.

- Positive serology for human immunodeficiency virus (HIV), hepatitis B virus (HBV)
(if not vaccinated) or hepatitis C virus (HCV).

- Any known or suspected allergies to the study drug or its constituents.

- Inadequate venous access to allow collection of blood samples.

- History of drug or alcohol abuse, consumption of alcohol within 48 hours prior to
treatment assignment, or a positive test for alcohol or drugs with a high
potential for abuse prior to treatment assignment and readmission to the Clinical
Research Unit (CRU).

- Subjects with history of (within the previous 12 months) or current use of
marijuana or positive urine drug screen for cannabinoids at screening or prior to
the first dose.

- History of seizures or current existing seizure disorder. High risk for seizure
disorders due to underlying medical condition and/or head trauma.

- Is a smoker of more than 10 cigarettes or 3 cigars or 3 pipes per day, and is
unable to refrain from smoking while confined to the CRU.

- Calculated creatinine clearance (using Cockroft and Gault formula) <80 mL/min.

- Resting 12-lead ECG showing QTcB interval >450 msec or any other clinically
significant abnormality in the opinion of the investigator/ sponsor.

- Blood donation, participation in a multiple blood draws clinical study 30 days
prior (>120 mL)

- Major trauma or surgery with or without blood loss within 90 days prior to
treatment assignment.

- Use of any experimental or investigational drugs within 30 days prior to
treatment assignment.

- Use of any prescription or nonprescription drugs, vitamins, or dietary
supplements within 14 days prior to treatment assignment, or expected use during
trial enrollment.

- Any current condition, that in either the Investigator's or sponsor's opinion
would represent an unacceptable safety risk while participating in this study or
interfere with trial participation or evaluation of results.

- Severe mental incapacity, unwillingness, language barrier, serious behavioral
issues, evidence of substance abuse, or any other situation, which would preclude
an understanding of, and adherence to study procedures