A phase I study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple-dose subcutaneous and intravenous administration of OMS721 in healthy subjects

A phase I study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple-dose subcutaneous and intravenous administration of OMS721 in healthy subjects - OMS721 MD SC and IV dose in HV

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42466

Enrollment

Registered

2015-05-06

Start date

2015-06-09

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

autoimmune diseases

Interventions

Group 1 and 2: During the study, the volunteer will stay in the clinical research center in Zuidlaren twice for a period of 5 days (4 nights) (from Day -1 to Day 4 and from Day 35 to Day 39

Day 1 is the first day of administration of study compound). On Days -1 and 35, you are expected to arrive at the clinical research center at 14:00 h in the afternoon. Group Days Treatment How oft

Day 1 is the day of administration of study compound). On Day 1, you are expected to arrive at the clinical research center at 14:00 h in the afternoon. The OMS721 dose level that the volunteer wi

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy volunteers 18-54 years, inclusive BMI: 19.0-32.0 kg/m2, inclusive

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 60 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 0.5 liters of blood in the 60 days prior the start of this study.

Design outcomes

Primary

Measure	Time frame
* Evaluate the safety and tolerability of multiple-dose subcutaneous (SC) and intravenous (IV) administration of OMS721 in healthy subjects * Evaluate the pharmacokinetics (PK) of multiple-dose SC and IV administration of OMS721 in healthy subjects * Evaluate the PK of an IV loading dose followed by SC administration of OMS721 in healthy subjects	—

Secondary

Measure	Time frame
* Evaluate the pharmacodynamics (PD) of multiple-dose SC and IV administration of OMS721 in healthy subjects * Evaluate the PD of an IV loading dose followed by SC administration of OMS721 in healthy subjects * Evaluate the anti-drug antibody (ADA) response following multiple-dose SC and IV administration of OMS721 in healthy subjects * Explore the effect of baseline mannan-binding lectin (MBL) and mannan-binding lectinassociated serine protease-2 (MASP-2) plasma concentrations on OMS721 pharmacodynamics * Explore the effect of OMS721 on MASP-2 and MBL plasma concentrations * Explore the effect of OMS721 on the classical and alternative complement pathways * Explore the size and duration of the effect of posture on total IgG plasma concentration	—

Measure

Time frame

* Evaluate the pharmacodynamics (PD) of multiple-dose SC and IV administration of OMS721 in healthy subjects * Evaluate the PD of an IV loading dose followed by SC administration of OMS721 in healthy subjects * Evaluate the anti-drug antibody (ADA) response following multiple-dose SC and IV administration of OMS721 in healthy subjects * Explore the effect of baseline mannan-binding lectin (MBL) and mannan-binding lectinassociated serine protease-2 (MASP-2) plasma concentrations on OMS721 pharmacodynamics * Explore the effect of OMS721 on MASP-2 and MBL plasma concentrations * Explore the effect of OMS721 on the classical and alternative complement pathways * Explore the size and duration of the effect of posture on total IgG plasma concentration

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)