A randomised, double-blind, placebo-controlled, study to investigate the safety, tolerability and pharmacokinetics of single ascending doses of MT-2990 in healthy male subjects.

A randomised, double-blind, placebo-controlled, study to investigate the safety, tolerability and pharmacokinetics of single ascending doses of MT-2990 in healthy male subjects. - MT-2990 SAD study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45915

Enrollment

Registered

2017-05-08

Start date

2017-05-08

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

ontstekingsziektes. inflammation

Interventions

Group 1, Day 1, 0.1 mg/kg MT-2990 or placebo administered as a 1 hour single dose IV infusion Group 2, Day 1, 0.3 mg/kg MT-2990 or placebo administered as a 1 hour single dose IV infusion Group 3, D

inflamation

MT-2990

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: healthy male subjects 18 - 55 years of age, inclusive BMI 18 - 30 kilograms/meter2, inclusive weight 60 - 100 kilograms, inclusive

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
Primary assessments: Incidence, nature and severity of adverse events (AEs) Vital signs (blood pressure, pulse rate and tympanic body temperature) ECG parameters (including HR and cardiac intervals: PR, QRS, QT and corrected QT interval using Fridericia*s formula [QTcF]) Clinical laboratory assessments (haematology, biochemistry, coagulation and urinalysis) Physical examination.	—

Secondary

Measure	Time frame
Secondary assessments: PK assessments PK concentrations vs. time profile of MT-2990. The following PK parameters of MT 2990 will be calculated after single dosing: Cmax Time to Cmax (tmax) t* AUC0-last AUC0-* Terminal elimination rate constant (Kel) Apparent volume of distribution at steady state (Vss) Apparent volume of distribution during the terminal phase after IV administration (Vz) Mean residence time from time zero to infinity (MRT0-*) Apparent serum clearance (CL) Percentage of AUC obtained by extrapolation (%AUCex). Immunogenicity Proportion of subjects who develop antibodies against MT-2990 in serum.	—

Measure

Time frame

Secondary assessments: PK assessments PK concentrations vs. time profile of MT-2990. The following PK parameters of MT 2990 will be calculated after single dosing: Cmax Time to Cmax (tmax) t* AUC0-last AUC0-* Terminal elimination rate constant (Kel) Apparent volume of distribution at steady state (Vss) Apparent volume of distribution during the terminal phase after IV administration (Vz) Mean residence time from time zero to infinity (MRT0-*) Apparent serum clearance (CL) Percentage of AUC obtained by extrapolation (%AUCex). Immunogenicity Proportion of subjects who develop antibodies against MT-2990 in serum.

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Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)