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

Completed

• Conditions: Asthma; COPD; 10027665

• Registration Number: NL-OMON35806
• Lead Sponsor: Orchid Research Laboratories Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 72

Inclusion Criteria

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pharmacokinetics :plasma and urine OCID 2987 concentrations, pharmacokinetic<br /><br>parameters<br /><br>Pharmacodynamics :TNF-alpha, IL-1 Beta, IL-6 and IL-8 in human plasma<br /><br>Safety : adverse events, vital signs, ECG-parameters,<br /><br>laboratory parameters, physical examination, telemetry</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>n.a.</p><br>