Healthy
Conditions
Keywords
Healthy Subjects
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.
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.
Interventions
DRUGPRS-080#022-DP
hepcidin antagonist
Placebo treatment
Sponsors
Nuvisan Pharma Services
FGK Clinical Research GmbH
EUROCALIN Consortium
Pieris Pharmaceuticals GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with adverse events | 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
| Measure | Time frame | Description |
|---|---|---|
| Assessment of anti-drug antibodies in blood following single administration | up to 28 days | Analysis of antibodies against PRS-080#22-DP at day 28 compared to baseline |
| Effect of PRS-080#22-DP on hepcidin concentrations in blood | 15 time points up to 28 days | Changes in hepcidin concentration compared to baseline |
| Pharmacokinetics of PRS-080#22-DP following administration of single doses | 14 time points up to 11 days | Area under the plasma concentration versus time curve (AUC) of PRS-080#22-DP in blood |
| Effect of PRS-080#22-DP on transferrin saturation | up to 28 days | Changes in transferrin saturation in blood compared to baseline |
| Effect of PRS-080#22-DP on ferritin | up to 28 days | Changes to ferritin concentration in blood compared to baseline |
| Effect of PRS-080#22-DP on total iron | up to 28 days | Changes in total iron concentration in blood compared to baseline |
Countries
Germany
Outcome results
None listed