MedTrace Logo

First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PRS-080

NCT02340572 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2015-08-10

No results posted yet for this study

Summary

Anticalins® are engineered human proteins that are able to bind specific target molecules. The Anticalin PRS-080#022-DP to be investigated in this study is directed against hepcidin and is intended for treatment of anemia of chronic disease. This phase I First-in-Human study shall investigate safety and pharmacokinetics in healthy human volunteers.

Conditions

  • Healthy

Interventions

DRUG

PRS-080#022-DP

hepcidin antagonist

DRUG

PRS-080-Placebo#001

Placebo treatment

Sponsors & Collaborators

  • Nuvisan Pharma Services

    collaborator UNKNOWN

  • FGK Clinical Research GmbH

    collaborator INDUSTRY

  • EUROCALIN Consortium

    collaborator UNKNOWN

  • Pieris Pharmaceuticals GmbH

    lead INDUSTRY

Principal Investigators

  • Ulrich Moebius, PhD · Pieris Pharmaceuticals GmbH

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2015-07-31
Completion
2015-08-31

Countries

  • Germany

Study Locations

More Related Trials

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 NCT02340572 on ClinicalTrials.gov