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'A phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single-dose intravenous and subcutaneous administration and multiple-dose subcutaneous administration of OMS906 in healthy subjects'

'A phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single-dose intravenous and subcutaneous administration and multiple-dose subcutaneous administration of OMS906 in healthy subjects' - Safety and PK of OMS906 in healthy volunteers.

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON49225
Enrollment
80
Registered
2020-07-01
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

blood disease that causes red blood cells to break apart

Interventions

Part A: 1 OMS906 or placebo 0.1 mg / kg ** IV infusion 2 OMS906 or placebo 0.3 mg / kg ** IV infusion 3 OMS906 or placebo 1.0 mg / kg ** IV infusion 4 OMS906 or placebo 3.0 mg / kg ** IV infusion 5 OM

Sponsors

Omeros Corporation
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Sex : male or female. 2. Age : 18 to 54 years, inclusive, at Screening. 3. Body mass index : 22.0 kg/m2 to 30.0 kg/m2 inclusive. 4. Status : healthy subjects.

Exclusion criteria

Exclusion criteria: 1. Previous participation in the current study. 2. Employee of PRA or the Sponsor, or their immediate family member. Immediate family is defined as current spouse, parent, natural or legally adopted child (including a stepchild living in the household), grandparent, or grandchild of Omeros or PRA employee. 3. History of relevant drug and/or food allergies (this includes known allergies for antimeningococcal antibiotic treatment 19). 4. Using tobacco products within 30 days prior to the Screening. 5. History of alcohol abuse or drug addiction (including soft drugs like cannabis products) within 3 years of Screening.

Design outcomes

Primary

MeasureTime frame
Part A: Single Ascending Dose (SAD) • To assess the safety and tolerability of OMS906, when administered as single ascending IV and SC doses in healthy subjects. Part B: Multiple Ascending Dose (MAD) • To assess the safety and tolerability of OMS906, when administered as multiple ascending SC doses in healthy subjects.—

Secondary

MeasureTime frame
Part A: SAD • To characterize the PK of OMS906, when administered as single ascending IV and SC doses in healthy subjects. • To characterize the PD of OMS906, when administered as single ascending IV and SC doses in healthy subjects. • To assess the presence of anti-drug antibodies (ADA) against OMS906 after single ascending IV and SC doses in healthy subjects. Part B: MAD • To characterize the PK of OMS906, when administered as multiple ascending SC doses in healthy subjects. • To characterize the PD of OMS906, when administered as multiple ascending SC doses in healthy subjects. • To assess the presence of ADAs against OMS906 after multiple ascending SC doses in healthy subjects.—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)