A Single-Center, Randomized, Observer-Blinded, Placebo-Controlled, Single-Ascending-Dose (SAD) Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO5469754, a Humanized Monoclonal Antibody, Following Intravenous or Subcutaneous Administration in Healthy Adults

A Single-Center, Randomized, Observer-Blinded, Placebo-Controlled, Single-Ascending-Dose (SAD) Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO5469754, a Humanized Monoclonal Antibody, Following Intravenous or Subcutaneous Administration in Healthy Adults - RO5469754 monoclonal antibody study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37629

Enrollment

Registered

2011-10-18

Start date

2011-11-01

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

Asthma breathing difficulties

Interventions

Active substance RO5469754

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy male or female age: 18-64 yrs, inclusive BMI: 18-32 kg/m2, inclusive

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 blood in the 10 months preceding the start of the study (male)/ more than 1.0 liters of blood in the 10 months preceding the start of the study (female).

Design outcomes

Primary

Measure	Time frame
Safety Pharmacokinetics Pharmacodynamics	—

Secondary

Measure	Time frame
n.a.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)