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

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ClinicalTrials.gov Identifier: NCT02340572
Recruitment Status : Completed
First Posted : January 16, 2015
Last Update Posted : August 10, 2015
Sponsor:
Collaborators:
Nuvisan Pharma Services
FGK Clinical Research GmbH
EUROCALIN Consortium
Information provided by (Responsible Party):
Pieris Pharmaceuticals GmbH

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: PRS-080#022-DP Drug: PRS-080-Placebo#001 Phase 1

Detailed Description:

First-in-Human (FIH), randomized, dose-escalation, double-blind, placebo-controlled single dose in healthy volunteers.

The single rising dose study will enroll 8 subjects per cohort (6 verum, 2 placebo), up to a maximum tolerated dose, defined by stopping rules. 6 dose levels are anticipated. Study drug will be administered as i.v. infusion on Day 1. The decision to escalate the dose by the dose escalation committee (DEC) will be based on an interim analysis of clinical safety and safety laboratory data.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: A First-in-Human, Randomized, Dose-Escalation, Double-Blind, Placebo-Controlled Single Ascending Dose Study to Establish Safety, Lack of Immunogenicity, Tolerability, Pharmacokinetic Parameters, Target Engagement and Pharmacodynamic Effects
Study Start Date : November 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : August 2015

Arm Intervention/treatment
Experimental: PRS-080#022-DP
hepcidin antagonist, single administration, ascending doses
Drug: PRS-080#022-DP
hepcidin antagonist
Other Name: PRS-080

Placebo Comparator: PRS-080-Placebo#001
Comparotor treatment, single administration
Drug: PRS-080-Placebo#001
Placebo treatment
Other Name: Placebo




Primary Outcome Measures :
  1. Number of subjects with adverse events [ Time Frame: up to 28 days ]
    Composite measure including signs and symptoms, local reactions, changes from baseline heart rate and blood pressure, ECG, body temperature, respiratory rate, clinical chemistry and hematology, coagulation and urinalysis over a 28 day period


Secondary Outcome Measures :
  1. Pharmacokinetics of PRS-080#22-DP following administration of single doses [ Time Frame: 14 time points up to 11 days ]
    Area under the plasma concentration versus time curve (AUC) of PRS-080#22-DP in blood

  2. Assessment of anti-drug antibodies in blood following single administration [ Time Frame: up to 28 days ]
    Analysis of antibodies against PRS-080#22-DP at day 28 compared to baseline

  3. Effect of PRS-080#22-DP on hepcidin concentrations in blood [ Time Frame: 15 time points up to 28 days ]
    Changes in hepcidin concentration compared to baseline

  4. Effect of PRS-080#22-DP on total iron [ Time Frame: up to 28 days ]
    Changes in total iron concentration in blood compared to baseline

  5. Effect of PRS-080#22-DP on transferrin saturation [ Time Frame: up to 28 days ]
    Changes in transferrin saturation in blood compared to baseline

  6. Effect of PRS-080#22-DP on ferritin [ Time Frame: up to 28 days ]
    Changes to ferritin concentration in blood compared to baseline



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy Caucasian males: based on a screening examination including medical history, physical examination, 12-lead ECG, vital signs and clinical laboratory profiles, age 18-50 years
  2. Subjects should have a body mass index of 18-30 kg/m2 and should weigh 60-90 kg
  3. Subjects must be using two acceptable methods for contraception (e.g. spermicide and condom) during the study and refrain from fathering a child in the 3 months following the last dosing.
  4. Willing to comply with the requirements of the study protocol and signing the informed consent sheet.

Exclusion Criteria:

  1. Any uncontrolled or active major systemic disease
  2. History or presence of malignancy
  3. Definite or suspected history of drug allergy
  4. Active acute or chronic infection, including, but not limited to: upper airway infection, urinary tract infection, and skin infection
  5. Use of any investigational drug within 30 days, or 5 half-lives, whichever is longer, prior to the planned first drug administration.
  6. Use of prescription medication within 14 days prior to the planned first drug administration and throughout the study (with the exception of medications given to treat an adverse event and use of non-prescription or over-the-counter medications within 7 days prior to the planned first drug administration and throughout the study (including vitamins, herbal supplements, or remedies
  7. Smoking greater than 20 cigarettes per week
  8. History of alcohol or substance abuse within the past 6 months prior to the planned first drug administration
  9. History of increased bleeding risk
  10. Clinically relevant abnormalities found in physical examination, vital signs measurements, laboratory safety tests or ECG
  11. Blood donation within the last 60 days prior to the planned first drug administration
  12. Positive results on hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV1/2) antibodies screening
  13. Iron overload or disturbance in utilization of iron (defined as ferritin > 300.0 ng/mL and < 10.0 ng/mL)
  14. i.v. iron treatment or blood transfusion within last 90 days prior to the planned first drug administration or during trial
  15. ESA (e.g. Erythropoietin) treatment within the last year
  16. Surgery or trauma with significant blood loss within 2 months before the planned first drug administration
  17. Not able to abstain from consumption of food or beverages known to influence dietary iron absorption

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02340572


Locations
Germany
Nuvisan GmbH
Neu-Ulm, Germany
Sponsors and Collaborators
Pieris Pharmaceuticals GmbH
Nuvisan Pharma Services
FGK Clinical Research GmbH
EUROCALIN Consortium
Investigators
Study Director: Ulrich Moebius, PhD Pieris Pharmaceuticals GmbH

Additional Information:
Responsible Party: Pieris Pharmaceuticals GmbH
ClinicalTrials.gov Identifier: NCT02340572     History of Changes
Other Study ID Numbers: PCS_01_12
First Posted: January 16, 2015    Key Record Dates
Last Update Posted: August 10, 2015
Last Verified: August 2015

Keywords provided by Pieris Pharmaceuticals GmbH:
Healthy Subjects