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

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 - Safety, PK and PD study with ENX-201

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46131

Enrollment

Registered

2018-09-27

Start date

2018-10-17

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis (MS)

Interventions

ENX-201 and Solu-medrol.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Fitzpatrick skin type 1-4 (inclusive) General good health Subjects aged 18 to 60 years (inclusive)

Exclusion criteria

Exclusion criteria: - 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

Design outcomes

Primary

Measure	Time frame
MPhs and MP plasma concentrations, PK characteristics in comparison to active comparator (AUC0 *, Cmax as primary variables).	—

Secondary

Measure	Time frame
• Treatment-emergent adverse events (TEAEs), infusion reactions, safety laboratory, vital signs, ECG, body weight, concomitant medication, physical examination. • LSEQ scores in comparison to active comparator and placebo. • Changes in ACTH and cortisol in comparison to active comparator and placebo. • Changes in lymphocyte count + differentiation in comparison to active comparator and placebo. • Complement (AP50, C3d and MBL), and inflammation parameters (C-reactive protein [CRP], erythrocyte sedimentation rate [ESR]).	—

Measure

Time frame

• Treatment-emergent adverse events (TEAEs), infusion reactions, safety laboratory, vital signs, ECG, body weight, concomitant medication, physical examination. • LSEQ scores in comparison to active comparator and placebo. • Changes in ACTH and cortisol in comparison to active comparator and placebo. • Changes in lymphocyte count + differentiation in comparison to active comparator and placebo. • Complement (AP50, C3d and MBL), and inflammation parameters (C-reactive protein [CRP], erythrocyte sedimentation rate [ESR]).

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)