MedTrace Logo

Pharmacokinetics and Safety Study of BI 695501 in Healthy Subjects

NCT01505491 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 193

Last updated 2019-02-20

Study results available
· View outcomes & findings →

Summary

This trial will investigate the pharmacokinetics, safety and tolerability of BI 695501 and to establish pharmacokinetic equivalence of BI 695501 to adalimumab.

Conditions

  • Healthy

Interventions

DRUG

adalimumab

40mg adalimumab single s.c. injection

DRUG

BI695501

BI 695501 single s.c injection

DRUG

adalimumab

40mg adalimumab single s.c. injection

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-12-01
Primary Completion
2012-07-01
Completion
2012-07-01

Countries

  • New Zealand

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 NCT01505491 on ClinicalTrials.gov