Multiple Sclerosis (relapses)
Conditions
Interventions
ENX-201 300mg, once, IV infusion in 5% dextrose/ Methylprednisolone hemisuccinate 300mg, once, IV infusion in 5% dextrose/ Placebo, once, IV infusion of 5% dextrose
Sponsors
EnhanX Biopharm Inc.
Eligibility
Inclusion criteria
Inclusion criteria: Healthy male and female volunteers, who are able to understand and follow study instructions, age between 18 and 60 years (inclusive), and weight within normal range (body mass index within 18 to 29.9 kg/m2) and at least 50 kg.
Exclusion criteria
Exclusion criteria: Demonstrating excess in xanthine consumption (more than 5 cups of coffee or equivalent per day); More than moderate alcohol consumption or a history of alcohol abuse; drug abuse; consumption of furanocoumarin containing citrus fruits within 7 days of first dosing; Consumption of quinine-containing drinks within 7 days of first dosing; Use of any medications other than highly effective anti-conceptive medicines, vitamins, mineral, herbal and dietary supplements within 21 days of first dosing.; Vaccinations within 3 months prior to screening; Demonstrating any active physical or psychiatric disease, acute or chronic; Any suicidal actuations (Columbia suicide severity rating-scale, CSSR-S); Any history of drug hypersensitivity, asthma, urticaria, multiple or severe allergies or drug allergies as well as current hay fever; Any history of hypersensitivity to the IMPs or components thereof; Any history of chronic or recurrent metabolic, renal, hepatic, pulmonary, gastrointestinal, neurological (esp. history of epileptic seizures), endocrinological, immunological, psychiatric or cardiovascular disease, myopathies, and bleeding tendency; Infection or inflammation within 1 month prior to first dosing; Clinically significant laboratory values outside the reference range; Clinically significant increased value of glycosylated hemoglobin; Positive test for HIV antibodies or Hepatitis B-virus or Hepatitis C-virus; Positive Mendel–Mantoux test; Blood donation of 500 mL or more within 3 months prior to screening; Having received any blood transfusions or blood components within 2 months prior to screening; Participation in the treatment phase of a clinical trial within 3 months prior to screening or blocked by the follow-up period of a previous clinical trial before signing informed consent to this trial; Women of childbearing potential not using a highly effective method of birth control; Women who are pregnant or breast-feeding; Male subjects who are not surgically sterile have to use contraception during sexual intercourse with women of childbearing potential; Subject is in custody; Criteria which in the opinion of the investigator preclude participation; Previous assignment to treatment (e.g. randomization) during this study; Close affiliation with the investigator; Unable/unwilling to comply with study restrictions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics in plasma of intravenously administered ENX-201 in terms of Cmax, Volume of distribution, half-life (T1/2), area under the plasma concentration-time curve (AUC), Clearance (CL) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Leeds Sleep Evaluation Questionnaire (LSEQ) scores in comparison to active comparator and placebo 2. Changes in adrenocorticotropic hormone (ACTH) in comparison to active comparator and placebo 3. Changes in lymphocyte count and lymphocyte differentiation 4. Complement (AP50, C3d, MBL), and inflammation parameters (C-reactive protein [CRP]) 5. Treatment-emergent adverse events (TEAEs), infusion reactions, safety laboratory, vital signs, electrocardiogram (ECG), body weight, concomitant medication, physical examination | — |
Contacts
Public ContactErik Doevendans
EnhanX Biopharm Inc.
Outcome results
None listed