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ONO-7746 Study in Healthy Adult Subjects

Phase 1
Completed
Conditions
Healthy Adult Subjects
Interventions
Drug: ONO-7746
Registration Number
NCT00956371
Lead Sponsor
Ono Pharmaceutical Co. Ltd
Brief Summary

The primary objective of this study is to evaluate the safety and tolerability of ONO-7746 in healthy adult subjects. The secondary objectives are to characterize the pharmacokinetic and pharmacodynamic profiles of ONO-7746.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
48
Inclusion Criteria
  • Healthy non-smoking male or female subjects (18-55 years inclusive)
  • Body mass index (BMI) of 19-35 kg/m² (inclusive)
  • For females: postmenopausal, non-lactating and non-pregnant
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Exclusion Criteria
  • History or presence of clinically significant disease
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PONO-7746-
EONO-7746-
Primary Outcome Measures
NameTimeMethod
Safety and tolerability of ONO-7746 across ascending single dosesstudy duration
Secondary Outcome Measures
NameTimeMethod
Characterization of PK and PD profiles of ONO-7746study duration

Trial Locations

Locations (1)

Austin

🇺🇸

Austin, Texas, United States

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