Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ONO-2952 in Healthy Adult Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: ONO-2952 Matching Placebo; Drug: ONO-2952

• Registration Number: NCT01489345
• Lead Sponsor: Ono Pharma USA Inc

Brief Summary

The primary objective of this study is to evaluate the safety and tolerability of ONO-2952 across ascending multiple doses in healthy adult male and female subjects. The secondary objective is to characterize the pharmacokinetic (PK) profile of ONO-2952.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-07
• Study First Submitted QC: 2011-12-08
• Study First Posted: 2011-12-09
• Primary Completion: 2012-04
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-31
• Last Update Posted: 2012-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Healthy non-smoking male or female subjects (18-55 inclusive)
• Body mass index (BMI) of 19-35 kg/m2 (inclusive)
• For females, surgically sterilized, postmenopausal, or who are non- lactating and agree to use a double barrier method of contraception

Exclusion Criteria

• History or presence of clinically significant disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2: Placebo Comparator	ONO-2952 Matching Placebo	-
Arm 1: Experimental	ONO-2952	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of ONO-2952 using vital signs, ECGs, laboratory tests, physical examinations, and incidence/severity of adverse events	36 days

Secondary Outcome Measures

Name	Time	Method
Characterization of PK of ONO-2952 in plasma samples	36 days

Trial Locations

Locations (1)

Austin Clinical Site; 🇺🇸 Austin, Texas, United States