A Single Ascending Dose Study of PCO371 in Healthy Volunteers

Chugai Pharmaceutical

Status and phase: Terminated; Phase 1

Conditions: Healthy

Treatments: Drug: PCO371; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02475616

PCO001US

Details and patient eligibility

About

This is a single-center, placebo-controlled, randomized, double-blind, dose-escalation study to evaluate safety, tolerability, and PK of a single oral (PO) administration of PCO371 in healthy adult males.

Caucasian and Japanese subjects will be randomized to receive either PCO371 or placebo.

Enrollment: 64 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male volunteers aged 18 to 45 years.
• Caucasian(BMI 18-30 mg/kg2) or first generation japanese(BMI 18-25kg/m2)
• Able and willing to abide by the protocol

Exclusion criteria

• Evidence of any medical condition that could affect renal, hepatic, or cardiopulmonary functions.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 2 patient groups, including a placebo group

PCO371

Experimental group

Description:

Single oral dose of PCO371

Treatment:

Drug: PCO371

Placebo Comparator

Placebo Comparator group

Description:

Single oral dose of placebo

Treatment:

Drug: Placebo