A single centre, prospective, randomised, double-blind, placebo controlled, sequential, dose-escalating phase I study to assess the safety and tolerability of intravenously infused single doses of OPN-305 in healthy subjects.

A single centre, prospective, randomised, double-blind, placebo controlled, sequential, dose-escalating phase I study to assess the safety and tolerability of intravenously infused single doses of OPN-305 in healthy subjects. - OPN-305 SAD study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38332

Enrollment

Registered

2011-04-11

Start date

2011-06-10

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

inflammatory reactions rejections

Interventions

Cohort 1: a single 2-hour iv infusion of 0.5 mg/kg OPN-305 or placebo in the fasted state Cohort 2: a single 2-hour iv infusion of 1.5 mg/kg OPN-305 or placebo in the fasted state Cohort 3: a single

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy male volunteers; 18 - 60 years; BMI 18.0 - 28.9 kg/m2; moderate or non-smoker.

Exclusion criteria

Exclusion criteria: Suffering from: hepatitis B, 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 90 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
Pharmacodynamics: antibodies concentrations, inflammatory cytokine levels, PD markers Pharmacokinetics: plasma OPN-305 concentrations, pharmacokinetic parameters Safety: adverse events, vital signs, ECG-parameters, laboratory parameters, physical examination	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)