A phase 1, single center, randomized, double-blind, placebo-controlled, single (Part 1) and multiple (Part 2) ascending dose study to evaluate the safety,tolerability, pharmacokinetics and pharmacodynamics of M281 administered to healthy volunteers.

A phase 1, single center, randomized, double-blind, placebo-controlled, single (Part 1) and multiple (Part 2) ascending dose study to evaluate the safety,tolerability, pharmacokinetics and pharmacodynamics of M281 administered to healthy volunteers. - M281 SAD/MAD study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43123

Enrollment

Registered

2016-04-14

Start date

2016-05-09

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

auto-immuunziekten en ontstekingsziekten. autoimmune diseases and inflammatory diseases

Interventions

Part 1: Group 1: 1 x 0.3 mg per kg bodyweight M281 or placebo Group 2: 1 x 3 mg per kg bodyweight M281 or placebo Group 3: 1 x 10 mg per kg bodyweight M281 or placebo Group 4: 1 x 30 mg per kg bodywei

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male or female subjects 18 - 55 years of age, inclusive BMI 18 - 30 kilograms/meter2, inclusive weight 50 -110 kg, inclusive non smoking

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study

Design outcomes

Primary

Measure	Time frame
To establish the safety and tolerability of ascending single (Part 1) and multiple doses (Part 2) of M281 relative to placebo, administered intravenously (IV) to healthy male and female volunteers at dose intensities that lead to progressively higher levels, and longer periods, of receptor occupancy (RO).	—

Secondary

Measure	Time frame
To evaluate the pharmacokinetics (PK) of M281 following single dose and multiple dose administration. To evaluate target engagement by M281 following single and multiple dose administration, where target engagement is assessed as FcRn RO in circulating monocytes and granulocytes To evaluate the pharmacodynamic (PD) effects of M281 when administered as ascending single or multiple doses, where the primary PD effect is assessed as circulating IgG level. Other exploratory PD effects to be assessed include the level of antigen-specific IgG, and levels of total IgG1, IgG2, IgG3, IgG4, IgA, IgM, and IgE. To evaluate the duration of target engagement and PD effects of M281. To determine an optimal dose and dosing interval for further studies by examining receptor occupancy, PD, and tolerability data from the single and multiple ascending dose periods. Information from the single dose (Part 1) portion will be used to re-estimate the appropriate doses and dosing interval for the multiple dose (Part 2) portion.	—

Measure

Time frame

To evaluate the pharmacokinetics (PK) of M281 following single dose and multiple dose administration. To evaluate target engagement by M281 following single and multiple dose administration, where target engagement is assessed as FcRn RO in circulating monocytes and granulocytes To evaluate the pharmacodynamic (PD) effects of M281 when administered as ascending single or multiple doses, where the primary PD effect is assessed as circulating IgG level. Other exploratory PD effects to be assessed include the level of antigen-specific IgG, and levels of total IgG1, IgG2, IgG3, IgG4, IgA, IgM, and IgE. To evaluate the duration of target engagement and PD effects of M281. To determine an optimal dose and dosing interval for further studies by examining receptor occupancy, PD, and tolerability data from the single and multiple ascending dose periods. Information from the single dose (Part 1) portion will be used to re-estimate the appropriate doses and dosing interval for the multiple dose (Part 2) portion.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)