Randomized, double blind, placebo- and active comparator- controlled 3-way crossover study in healthy subjects to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ENX-201
- Conditions
- Multiple Sclerosis (MS)10012303
- Registration Number
- NL-OMON46131
- Lead Sponsor
- EnhanX Biopharm Inc.
- Brief Summary
Trial ended prematurely
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
Fitzpatrick skin type 1-4 (inclusive)
General good health
Subjects aged 18 to 60 years (inclusive)
- More than moderate smoker (>10 cigarettes or equivalent tobacco products/day).
- More than moderate alcohol consumption. Defined as an average weekly intake of more than 21 units or an average daily intake of more than 3 units (males), or defined as an average weekly intake of more than 14 units or an average daily intake of
more than 2 units (females).
- Use of any medications (prescription or over the counter) other than highly effective anti-conceptive medicines, vitamins, mineral, herbal and dietary supplements within 21 days of first dosing.
- Any history of drug hypersensitivity, asthma, urticaria, multiple or severe allergies or drug allergies as well as current hay fever. Note: nonactive hay fever is acceptable.
- Positive test for human immunodeficiency virus antibodies, hepatitis B-virus surface antigen, Anti-hepatitis C-virus antibodies.
- Positive test result for tuberculosis testing.
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>MPhs and MP plasma concentrations, PK characteristics in comparison to active<br /><br>comparator (AUC0 *, Cmax as primary variables).</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Treatment-emergent adverse events (TEAEs), infusion reactions, safety<br /><br>laboratory, vital signs, ECG, body weight, concomitant medication, physical<br /><br>examination.<br /><br>• LSEQ scores in comparison to active comparator and placebo.<br /><br>• Changes in ACTH and cortisol in comparison to active comparator and placebo.<br /><br>• Changes in lymphocyte count + differentiation in comparison to active<br /><br>comparator and placebo.<br /><br>• Complement (AP50, C3d and MBL), and inflammation parameters (C-reactive<br /><br>protein [CRP], erythrocyte sedimentation rate [ESR]).</p><br>