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Pharmacokinetics and Safety in Healthy Volunteers

NCT02045979 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 327

Last updated 2018-06-20

Study results available
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Summary

Investigate the pharmacokinetics, safety and tolerability of BI695501 and to establish pharmacokinetic similarity of BI 695501 to adalimumab.

Conditions

  • Healthy

Interventions

DRUG

BI 695501

BI 695501 single s.c. injection

DRUG

adalimumab-EU source

adalimumab-EU source single s.c. injection

DRUG

adalimumab-US source

adalimumab-US source single s.c. injection.

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-06-20
Completion
2014-06-20

Countries

  • Belgium
  • New Zealand

Study Locations

More Related Trials

Entities

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 NCT02045979 on ClinicalTrials.gov