A randomized, placebo-controlled, double-blind, single ascending dose study to evaluate the safety, tolerability and pharmacokinetics of NX210 in healthy volunteers.

Completed

Conditions: Neurological disorders
spinal cord injury
10041543

Registration Number: NL-OMON49076

Lead Sponsor: Axoltis Pharma

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

Subject is a male or is a female of non-childbearing potential, aged between 18
and 55 years (inclusive).
A body weight of >=50.0 kg and <=90.0 kg (85.0 kg for Cohort 5 at the highest
dose) and a body mass index (BMI) of >=18.0 kg/m2 and <=30.0 kg/m2 at Screening.
Healthy as determined by the Investigator, based upon a medical evaluation
including medical history, physical examination, neurological examination, lab
tests and ECG performed at screening.
Subjects understand the study, can give written informed consent at Screening,
and are willing to comply with the requirements and restrictions of the study.

Exclusion Criteria

Prior or ongoing medical condition, medical history, physical findings, ECG
findings, laboratory or vital signs abnormality that, in the Investigator's
opinion, could adversely affect the safety of the subject.
The subject has a current or recurrent disease (e.g., cardiovascular,renal,
liver, gastrointestinal, malignancy or other conditions) that could affect the
distribution, metabolism or excretion of the investigational product or could
affect clinical or laboratory assessments.
History of any clinically significant allergy, hypersensitivity or intolerance.
Subject with one or more of the following laboratory abnormalities at Screening
and between Screening and dosing: abnormal Alanine aminotransferase (AST),
abnormal aspartate aminotransferase (ALT) or abnormal alkaline phosphatase
levels (ALP) >=1.5 x upper limit of normal (ULN); total bilirubin >=1.5 x ULN; or
clinically significant laboratory abnormalities or abnormalities which are
deemed to interfere with the ability to interpret study data. A repeat is
allowed once to determine eligibility.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The following are defined as safety/tolerability parameters:<br /><br>Physical examination;<br /><br>(Serious) adverse events (SAEs and AEs);<br /><br>Clinical laboratory assessments including hematology, biochemistry and<br /><br>urinalysis;<br /><br>12-lead ECG;<br /><br>Telemetry;<br /><br>Vital signs;<br /><br>Local tolerability.<br /><br><br /><br>The following are defined as PK plasma parameters for NX210 via its metabolite<br /><br>NX210c (calculated using a non-compartmental model):<br /><br>Maximum concentration (Cmax);<br /><br>Time to Cmax (tmax);<br /><br>Terminal elimination rate constant (Kel);<br /><br>Terminal elimination half-life (t1/2);<br /><br>Area under the concentration-time curve (AUC) from time of dosing (zero) to<br /><br>time t of the last measured concentration above the limit of quantification<br /><br>(AUC0-t);<br /><br>AUC under the concentration-time curve from time zero to infinity (AUC0-inf);<br /><br>Total clearance (CL);<br /><br>Volume of distribution (Vz).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Nap</p><br>

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