Healthy Adult Subjects Clinical Trial
Official title:
A Phase 1, Single Centre, Three-part, Randomised, Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of Single and Multiple Ascending Doses of Oral ONO-4053 and the Effects of Food in Healthy Males and Females
The primary objective of this study is to evaluate the safety and tolerability of ONO-4053
across ascending single and multiple doses in healthy adult male and female subjects.
The secondary objective of the study is to characterize the pharmacokinetic profile of
ONO-4053 in healthy adult male and female subjects.
Ono Pharma UK Ltd is the European subsidiary of Ono Pharmaceutical Co. Ltd. As the European
Legal Representative of Ono Pharmaceutical Co. Ltd, Ono Pharma UK Ltd is carrying out this
study.
This is a clinical study of ONO-4053 in healthy volunteers. This study consists of three
parts. Part A will investigate the safety, tolerability and pharmacokinetics when single
ascending doses of ONO-4053 are administered in a double-blind manner. Part B will
investigate the pharmacokinetics of ONO-4053 in the fed and fasted state in an open-label
manner. Part C will investigate the safety, tolerability and pharmacokinetics when multiple
ascending doses of ONO-4053 are administered in a double-blind manner. Doses for Part B and
C will be determined after data from Part A are available.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03267732 -
A Study to Evaluate the Pharmacokinetics in Participants After Dosing With Pegilodecakin (LY3500518)
|
Phase 1 | |
| Completed |
NCT05040113 -
A Study On Human Mass Balance And Biotransformation
|
Phase 1 | |
| Completed |
NCT01433835 -
Safety and Pharmacokinetics of Single Oral Doses of MBX-400 in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT04029090 -
A Study to Evaluate the Effect of MCI-186 at Therapeutic and Supra-Therapeutic Doses on the QT Interval(QT)/Corrected QT Interval(QTc) Interval in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT04586985 -
Safety, Tolerability and Pharmacokinetics of FTX-6058
|
Phase 1 | |
| Completed |
NCT04481789 -
Clinical Pharmacology Study of Oral Edaravone in Healthy Adult Males (Drug Interaction Study and Preliminary Regimen-Finding Study)
|
Phase 1 | |
| Completed |
NCT06107205 -
Bioequivalence of TTYP01 Tablets in Healthy Adult Subjects
|
Phase 1 | |
| Completed |
NCT04629131 -
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TNM002 in Healthy Adults
|
Phase 1 | |
| Recruiting |
NCT06063291 -
Single Ascending Oral Dose Phase 1 Study of ID110521156 in Healthy Adult Subjects
|
Phase 1 | |
| Completed |
NCT04203862 -
A Study of NPC-22 in Healthy Adult Males
|
Phase 1 | |
| Recruiting |
NCT05641181 -
A Trial of CRB4101 in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT04521192 -
Bioequivalence of Fluzoparib(SHR3162) Study on Healthy Chinese Adult Subjects
|
Phase 1 | |
| Completed |
NCT04400123 -
A Bioequivalence Study of Famitinib Malate on Healthy Chinese Volunteers
|
Phase 1 | |
| Completed |
NCT04811469 -
Safety, Tolerability and Pharmacokinetics of CBP-174 in Healthy Adults
|
Phase 1 | |
| Completed |
NCT04291846 -
A Food Effect Study of SHR1459 on Healthy Chinese Adult Subjects
|
Phase 1 | |
| Completed |
NCT01364441 -
Single-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ONO-2952 in Healthy Adult Subjects
|
Phase 1 | |
| Completed |
NCT02691702 -
Multiple Dose Study Of BIIB118 (PF-05251749) In Healthy Volunteers
|
Phase 1 | |
| Recruiting |
NCT05334043 -
Pharmacokinetics and Bioavailability of Curcumin UP 30 Capsules in Healthy Adult Subjects
|
Phase 1 | |
| Completed |
NCT04493281 -
Bioequivalence Study of Oral Suspension and Intravenous Formulation of Edaravone in Healthy Adult Subjects
|
Phase 1 | |
| Completed |
NCT01376063 -
Study to Investigate the Interaction Between FG-4592 and Rosiglitazone in Healthy Adult Subjects
|
Phase 1 |