A randomized double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety and pharmacokinetics of OCR 002 in healthy volunteers.

A randomized double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety and pharmacokinetics of OCR 002 in healthy volunteers. - OCR-002 SAD+MAD study in HV

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34455

Enrollment

Registered

2010-05-18

Start date

2010-05-26

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Liver failure

Interventions

Active substance OCR-0002 or placebo

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy male and female subjects 18 - 55 years of age

Exclusion criteria

Exclusion criteria: Suffering from: hepatitis B, cancer or HIV/AIDS/ In case of participation in another drug study withing 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 to the start of this study.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics: plasma OCR-002 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)