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

NCT02340572 | Completed Phase 1 DMC

• 1 other identifier: PCS_01_12
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• Number of subjects with adverse events

  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

  up to 28 days

Secondary Outcomes (6)

• Pharmacokinetics of PRS-080#22-DP following administration of single doses

  14 time points up to 11 days

• Assessment of anti-drug antibodies in blood following single administration

  up to 28 days

• Effect of PRS-080#22-DP on hepcidin concentrations in blood

  15 time points up to 28 days

• Effect of PRS-080#22-DP on total iron

  up to 28 days

• Effect of PRS-080#22-DP on transferrin saturation

  up to 28 days

Study Arms (2)

PRS-080#022-DP

EXPERIMENTAL

hepcidin antagonist, single administration, ascending doses

Drug: PRS-080#022-DP

PRS-080-Placebo#001

PLACEBO COMPARATOR

Comparotor treatment, single administration

Drug: PRS-080-Placebo#001

Interventions

PRS-080#022-DP DRUG

hepcidin antagonist

Also known as: PRS-080

PRS-080#022-DP

PRS-080-Placebo#001 DRUG

Placebo treatment

Also known as: Placebo

PRS-080-Placebo#001

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Subjects should have a body mass index of 18-30 kg/m2 and should weigh 60-90 kg
• 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.
• Willing to comply with the requirements of the study protocol and signing the informed consent sheet.

You may not qualify if:

• Any uncontrolled or active major systemic disease
• History or presence of malignancy
• Definite or suspected history of drug allergy
• Active acute or chronic infection, including, but not limited to: upper airway infection, urinary tract infection, and skin infection
• Use of any investigational drug within 30 days, or 5 half-lives, whichever is longer, prior to the planned first drug administration.
• 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
• Smoking greater than 20 cigarettes per week
• History of alcohol or substance abuse within the past 6 months prior to the planned first drug administration
• History of increased bleeding risk
• Clinically relevant abnormalities found in physical examination, vital signs measurements, laboratory safety tests or ECG
• Blood donation within the last 60 days prior to the planned first drug administration
• Positive results on hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV1/2) antibodies screening
• Iron overload or disturbance in utilization of iron (defined as ferritin \> 300.0 ng/mL and \< 10.0 ng/mL)
• i.v. iron treatment or blood transfusion within last 90 days prior to the planned first drug administration or during trial
• ESA (e.g. Erythropoietin) treatment within the last year

Sponsors & Collaborators

• Pieris Pharmaceuticals GmbH: lead
• Nuvisan Pharma Services: collaborator
• FGK Clinical Research GmbH: collaborator
• EUROCALIN Consortium: collaborator

Study Sites (1)

Nuvisan GmbH

Neu-Ulm, Germany

Location

Study Officials

• Ulrich Moebius, PhD

  Pieris Pharmaceuticals GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2014
• First Posted: January 16, 2015
• Study Start: November 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 10, 2015

Record last verified: 2015-08

Locations

DE (1)