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First Human Dose Trial of NNC0215-0384 in Subjects With Rheumatoid Arthritis

NCT01611688 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2017-02-27

No results posted yet for this study

Summary

This trial is conducted in Europe. The aim of this trial is to describe the safety and tolerability of single intravenous (i.v.) and subcutaneous (s.c.) doses of NNC0215-0384 in subjects with active rheumatoid arthritis (RA) on background methotrexate (MTX) treatment.

Conditions

Interventions

DRUG

NNC0215-0384

I.v.(intravenous) dose-escalation. Highest dose planned for i.v. administration is 10 mg/kg

DRUG

placebo

Administered i.v.(intravenous) or s.c. (subcutaneous, under the skin).

DRUG

NNC0215-0384

The s.c. (subcutaneous, under the skin) part will not start until at least two i.v. dose levels have been evaluated for safety and pharmacokinetics. Highest dose planned for s.c. administration is 4 mg/kg

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR,1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-04
Primary Completion
2013-06-17
Completion
2013-06-17

Countries

  • Germany

Study Locations

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Entities

Drugs
Diseases
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 NCT01611688 on ClinicalTrials.gov