No registrations found.
ID
Source
Brief title
Health condition
Multiple Sclerosis (relapses)
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
In this human volunteers study, the aim is to assess the safety, pharmacokinetics and pharmacodynamics of ENX-201 in a randomized, double-blind, placebo- and active comparator- controlled 3-way crossover study in 12 healthy subjects.
Study objective
A relationship exists between a pharmacologic effect of ENX-201 and the plasma concentration
Study design
-2h, -15m, 0, 15m, 30m, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 30h, 48h, 72h
Intervention
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
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
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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL7595 |
Other | METC : METC NL67468.056.18 |