Ascending single dose study of the safety, tolerability, and pharmacokinetics of PRM-151 administered to healthy volunteers and patients with idiopathic pulmonary fibrosis (IPF)

Ascending single dose study of the safety, tolerability, and pharmacokinetics of PRM-151 administered to healthy volunteers and patients with idiopathic pulmonary fibrosis (IPF) - FIH of PRM-151

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON33156

Enrollment

Registered

2009-06-18

Start date

2009-07-22

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

anti-fibrose (meerdere indicaties) disturbed wound healing excessive scar formation

Interventions

Single doses of PRM-151 ranging from .1 to 20 mg/kg ( .1, .25, .5, 1, 2, 5, 10, and 20) will be evaluated in healthy subjects. Doses may be administered as an intravenous infusion over 30 minutes. E

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy subjects: healthy, age: 18-55 yrs; BMI:18-33 kg/m2; IPF Patients: IPF diagnosis, FVC>45% corrected for age, DLCO 40-80%, age: 18-72, BMI:18-33 kg/m2;

Exclusion criteria

Exclusion criteria: Healthy subjects: Active inflammation; acute or chronic disease; positive drug screen IPF Patients: amyloidosis, connective tissue disorder, COPD, tuberculosis, cystic fibrosis, acute disease state, positive drug screen

Design outcomes

Primary

Measure	Time frame
Safety and tolerability will be evaluated from reported adverse events, scheduled physical examinations, vital signs, 12-lead ECGs, and clinical laboratory test results.	—

Secondary

Measure	Time frame
Pharmacokinetics: Blood samples will be obtained to determine the PK of PRM-151. Blood samples (4 mL) will be obtained within 2 hours before test article administration and at different timepoints after test article administration. Pharmacodynamics: Blood samples will be collected for the purpose of analysis related to the effects, mechanism, dynamics and/or adverse events of PRM-151. MCP1, IP10 and MDC are examples of biomarkers that may be examined based on the information gained during the study and the biomarker strategy. Additional assays may be performed that contribute to the objectives of the trial. Pharmacodynamic samples will be collected on study day 1 before test article administration and at different timepoints after test article administration. Pharmacogenetics: An optional blood sample may be collected on day 1 before test article administration and stored for possible future genotyping of genes related to drug effects, mechanism, dynamics and adverse events.	—

Measure

Time frame

Pharmacokinetics: Blood samples will be obtained to determine the PK of PRM-151. Blood samples (4 mL) will be obtained within 2 hours before test article administration and at different timepoints after test article administration. Pharmacodynamics: Blood samples will be collected for the purpose of analysis related to the effects, mechanism, dynamics and/or adverse events of PRM-151. MCP1, IP10 and MDC are examples of biomarkers that may be examined based on the information gained during the study and the biomarker strategy. Additional assays may be performed that contribute to the objectives of the trial. Pharmacodynamic samples will be collected on study day 1 before test article administration and at different timepoints after test article administration. Pharmacogenetics: An optional blood sample may be collected on day 1 before test article administration and stored for possible future genotyping of genes related to drug effects, mechanism, dynamics and adverse events.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)