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drugset / Trial / NCT03571594

A Four-Part Study to Assess the Safety, Tolerability, PK and PD of ONO-5788 in Healthy Adult Volunteers

NCT03571594 ↗

Phase 1 Terminated 76 enrolled Ono Pharmaceutical Co., Ltd.
RandomizedSequentialQuadruple-blindTreatment

Summary

This is a first in human study to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of ONO-5788 in healthy adult volunteers. This study will be conducted in 4 parts: a single-ascending dose part, a multiple-ascending dose part, an elderly part and a proof of principle part.

Timeline

Start
2018-06-07
Primary completion
2019-05-16
Completion
2019-05-16

Drugs

EvaluationDrugModalityDoseRoute
Subject ONO-5788 Unknown — Oral
Comparator Octreotide Peptide — —

Indications

acromegaly