nerve disease Neuromyelitis optica
Conditions
Interventions
None listed
Sponsors
Clene Nanomedicine
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities. 2. Is between the ages of 18 and 45 years, inclusive. 3. Females will be non-pregnant, non-lactating, and either post-menopausal for at least 1 year, surgically sterile (e.g., tubal ligation, hysterectomy) for at least 90 days, or agree, from the time of signing the informed consent or 14 days prior to check-in until 30 90 days after Study Completion/Discharge, to use two forms of contraception. 4. Has a body mass index (BMI) between 18 and 34 kg/m2. 5. All laboratory values at screening fall within normal range or are evaluated as not clinically significant (NCS) by the Investigator if outside normal range. 6. Has no clinically significant abnormal findings during pre-dose physical examination or Screening and Baseline vital signs or ECG. 7. Has not consumed and agrees to abstain from taking any dietary supplements or non- prescription drugs (except as authorized by the Investigator AND Medical Monitor) for 3 days prior to CRU admission through Follow-Up. 8. Has not consumed and agrees to abstain from taking any prescription drugs (except as authorized by the Investigator AND Medical Monitor) during the 14 days prior to CRU admission through Follow-Up. 9. Has not consumed alcohol-containing beverages for starting 3 days prior to CRU admission and agrees not to consume alcohol through Follow-Up. 10. Has not consumed grapefruit or grapefruit juice within the 14 days prior to CRU admission and agrees not to consume grapefruit or grapefruit juice through Follow-Up. 11. Has not used tobacco- and nicotine-containing products within 60 days prior to the CRU admission and agrees to abstain from using tobacco- and nicotine-containing products through Follow-Up. 12. Has the ability to understand the requirements of the study and is willing to comply with all study procedures.
Exclusion criteria
Exclusion criteria: 1. Has a history of illicit drug abuse in the past year or current evidence of such abuse in the opinion of the Investigator. 2. Has positive findings on urine drug screen. 3. Is positive for human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C on screening assessments. 4. Is pregnant or lactating. 5. Has clinically significant medical or psychiatric history that, in the Investigator*s judgment, would compromise the subject*s safety or the collection of data. 6. Has donated plasma within 7 days of CRU admission. 7. Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening. 8. Participation in a clinical trial within 90 days of screening or more than 4 times in the previous year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic endpoints: SAD Phase: maximum observed plasma concentration (Cmax), time to Cmax (Tmax), the area under the plasma concentration versus time curve from time 0 (predose) to time infinity (AUCinf), AUC from time 0 to time of last measurable plasma concentration (AUClast), the percentage of the AUC that is extrapolated beyond the last measurable concentration (AUCext), the elimination rate constant (*z), the apparent systemic clearance (CL/F), mean residence time (MRT), apparent volume of distribution, terminal phase (Vz/F), and terminal-phase half-life (t*) will be calculated using non-compartmental analyses and PK modeling. MAD Phase: pharmacokinetic parameters such as the maximum observed plasma concentration (Cmax), time to Cmax (Tmax), Cmin, and the area under the plasma concentration versus time curve from time 0 (predose) to the end of the 24-hour dosing interval (AUC*) will be calculated on Days 1, 7, 14 and 21. The apparent systemic clearance (CL/F) will be calculated from the steady-state concentration-time profile. Other parameters such as the accumulation ratio (RAcc) elimination rate constant (*z), mean residence time (MRT), apparent volume of distribution, terminal phase (Vz/F), and terminal-phase half-life (t*) will be calculated when appropriate using non-compartmental analyses and PK modeling. Safety endpoints are as follows: • Incidence of treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) grouped by body system • Changes from Baseline in clinical laboratory, urinalysis, vital signs, and ECG parameters to discharge and Follow-Up • Changes from pre-dose physical exam findings to Follow-Up | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacodynamic endpointss • TLR9-induced cytokines • Other related cytokines | — |
Countries
Netherlands
Outcome results
None listed