A randomised, double-blind, placebo-controlled, ascending single and multiple dose first-in-human study to demonstrate the safety, tolerability and pharmacokinetics of ANXV administered as an intravenous infusion to healthy male subjects.

A randomised, double-blind, placebo-controlled, ascending single and multiple dose first-in-human study to demonstrate the safety, tolerability and pharmacokinetics of ANXV administered as an intravenous infusion to healthy male subjects. - CS0356-200226

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON51171

Enrollment

Registered

2020-10-09

Start date

2020-12-21

Completion date

Unknown

Last updated

2024-04-09

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

Conditions

Retinal vein occlusion

Interventions

intravenous doses of ANXV or placebo

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Willing and able to give written informed consent for participation in the study. Healthy male subject aged 18-60 years inclusive. Body Mass Index (BMI) >= 18.0 and

Exclusion criteria

Exclusion criteria: History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject*s ability to participate in the study. Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP. Malignancy within the past 5 years with the exception of in situ removal of basal cell carcinoma. Any planned major surgery within the duration of the study. Any positive result on screening for serum hepatitis B surface antigen (HbsAg), hepatitis C antibody and Human Immunodeficiency Virus (HIV).

Design outcomes

Primary

Measure	Time frame
Part I: Frequency, intensity and seriousness of adverse events (AEs) Clinically significant changes in: -ECG -Telemetric recordings -Vital signs (blood pressure, pulse, body temperature, respiratory rate, pulse oximetry) -Safety laboratory parameters -Physical examinations Incidence and titre of ADA to ANXV Part II: Frequency, intensity and seriousness of AEs Clinically significant changes in: -ECG -Telemetric recordings -Vital signs (blood pressure, pulse, body temperature, respiratory rate, pulse oximetry) -Safety laboratory parameters -Physical examinations Incidence and titre of ADA to ANXV	—

Measure

Time frame

Part I: Frequency, intensity and seriousness of adverse events (AEs) Clinically significant changes in: -ECG -Telemetric recordings -Vital signs (blood pressure, pulse, body temperature, respiratory rate, pulse oximetry) -Safety laboratory parameters -Physical examinations Incidence and titre of ADA to ANXV Part II: Frequency, intensity and seriousness of AEs Clinically significant changes in: -ECG -Telemetric recordings -Vital signs (blood pressure, pulse, body temperature, respiratory rate, pulse oximetry) -Safety laboratory parameters -Physical examinations Incidence and titre of ADA to ANXV

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Secondary

Measure	Time frame
Part I: PK parameters (will be calculated if sufficient data are available): -Area under the plasma concentration vs time curve from time zero extrapolated to infinity (AUCinf) -AUC from time zero to time of last quantifiable analyte concentration (AUClast) -Observed maximum concentration (Cmax) -Time to Cmax (Tmax) -Terminal slope of a semi-logarithmic concentration-time curve (z) -Terminal half life (T) -Clearance (CL) -Volume of distribution (Vz) -Dose proportionality after a single dose, based on AUC and Cmax -Fraction excreted in urine (fe) Part II: PK parameters after first dose (will be calculated if sufficient data are available): -AUClast -Cmax -Tmax -z -T -CL -Vz -Dose proportionality - Fraction excreted in urine (fe) (only cohort 3) PK parameters after last dose: -AUC during a dosage interval (tau) (AUCtau) -Cmax -Tmax -z -T -CL -Vz -Vss -Dose proportionality after multiple doses, based on AUC at steady state (AUCtau) and Cmax -Accumulation ratio -Minimum plasma concentrations of ANXV on Day 5 (Cmin) -Mean plasma concentrations of ANXV on Day 5 (Cmean)- Fraction excreted in urine (fe) (only cohort 3)	—

Measure

Time frame

Part I: PK parameters (will be calculated if sufficient data are available): -Area under the plasma concentration vs time curve from time zero extrapolated to infinity (AUCinf) -AUC from time zero to time of last quantifiable analyte concentration (AUClast) -Observed maximum concentration (Cmax) -Time to Cmax (Tmax) -Terminal slope of a semi-logarithmic concentration-time curve (*z) -Terminal half life (T*) -Clearance (CL) -Volume of distribution (Vz) -Dose proportionality after a single dose, based on AUC and Cmax -Fraction excreted in urine (fe) Part II: PK parameters after first dose (will be calculated if sufficient data are available): -AUClast -Cmax -Tmax -*z -T* -CL -Vz -Dose proportionality - Fraction excreted in urine (fe) (only cohort 3) PK parameters after last dose: -AUC during a dosage interval (tau) (AUCtau) -Cmax -Tmax -*z -T* -CL -Vz -Vss -Dose proportionality after multiple doses, based on AUC at steady state (AUCtau) and Cmax -Accumulation ratio -Minimum plasma concentrations of ANXV on Day 5 (Cmin) -Mean plasma concentrations of ANXV on Day 5 (Cmean)- Fraction excreted in urine (fe) (only cohort 3)

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)