A PHASE I, RANDOMIZED, DOUBLE BLIND PLACEBO * CONTROLLED, SINGLE AND MULTIPLE DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF OCID 2987 IN HEALTHY MALE SUBJECTS

A PHASE I, RANDOMIZED, DOUBLE BLIND PLACEBO * CONTROLLED, SINGLE AND MULTIPLE DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF OCID 2987 IN HEALTHY MALE SUBJECTS - OCID 2987 SAD/MAD study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35806

Enrollment

Registered

2011-02-23

Start date

2011-03-29

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

Asthma COPD

Interventions

Active substance: OCID 2987

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Healthy men - 18-55 years of age, inclusive - BMI 18.0-29.0 kg/m2, inclusive - Non-smoking

Exclusion criteria

Exclusion criteria: Suffering from: hepatitis B, hepatitis C 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 60 days from the start of the study. In case of donating more than 1.5 liters of blood (for men) or more than 1.0 liters of blood (for woman) in the 10 months prior the start of this study.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics :plasma and urine OCID 2987 concentrations, pharmacokinetic parameters Pharmacodynamics :TNF-alpha, IL-1 Beta, IL-6 and IL-8 in human plasma Safety : adverse events, vital signs, ECG-parameters, laboratory parameters, physical examination, telemetry	—

Secondary

Measure	Time frame
n.a.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)