Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-6950 in Healthy Adult Subjects

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Adult Subjects

In brief

The primary objective of this study is to evaluate the safety and tolerability of ONO-6950 across ascending multiple doses in healthy adult male and female subjects. The secondary objectives are to characterize the PK and pharmacodynamic (PD) profiles of ONO-6950 by measuring plasma concentrations of ONO-6950 and pulmonary function.

Key facts

Study ID

NCT01405651

Run by

Ono Pharma USA Inc

People needed

24

Starts

2011-07-01

Last updated by the study team

2012-06-14

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy non-smoking male or female subjects (18-55 inclusive)
• Body mass index (BMI)of 10-35 kg/m2 (inclusive)
• For females; postmenopausal, non-lactating, and non-pregnant

You may not qualify if…

• History or presence of clinical significant disease

Where it is running

• Miramar Clinical Site — Miramar, Florida, United States

Full record on ClinicalTrials.gov

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