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Safety and Pharmacokinetics of Multiple Doses of BI 655064 in Healthy Chinese Male Volunteers

NCT02331277 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-08-21

Study results available
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Summary

The primary objective of this trial is to investigate the safety and tolerability of multiple doses of BI 655064 following weekly subcutaneous injection for 4 weeks in healthy Chinese male volunteers.

The secondary objective is the exploratory evaluation of the pharmacokinetics and pharmacodynamics of multiple doses of BI 655064 following weekly subcutaneous injection for 4 weeks in healthy Chinese male volunteers.

Conditions

  • Healthy

Interventions

DRUG

BI 655064

subcutaneous injection

DRUG

Placebo

Placebo

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-01
Primary Completion
2016-05-25
Completion
2016-05-25

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02331277 on ClinicalTrials.gov