HealthyPhase 1NCT02340572
First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PRS-080
A Phase 1 study testing PRS-080#022-DP in people with Healthy, run by Pieris Pharmaceuticals GmbH at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PRS-080#022-DP
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2014to Aug 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
- Surgery or trauma with significant blood loss within 2 months before the planned first drug administration
- Not able to abstain from consumption of food or beverages known to influence dietary iron absorption
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- PRS-080#022-DP, PRS-080-Placebo#001
- Keywords
- Healthy Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRS-080#022-DPDrug
Also called PRS-080
hepcidin antagonist
PRS-080-Placebo#001Drug
Also called Placebo
Placebo treatment
| Study group | Role | What they receive |
|---|---|---|
| PRS-080#022-DP | Experimental | hepcidin antagonist, single administration, ascending doses Receives: Drug: PRS-080#022-DP |
| PRS-080-Placebo#001 | Placebo comparator | Comparotor treatment, single administration Receives: Drug: PRS-080-Placebo#001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 28 days
Secondary outcomes (6)
Pharmacokinetics of PRS-080#22-DP following administration of single doses
Area under the plasma concentration versus time curve (AUC) of PRS-080#22-DP in blood
Measured: 14 time points up to 11 days
Assessment of anti-drug antibodies in blood following single administration
Analysis of antibodies against PRS-080#22-DP at day 28 compared to baseline
Measured: up to 28 days
Effect of PRS-080#22-DP on hepcidin concentrations in blood
Changes in hepcidin concentration compared to baseline
Measured: 15 time points up to 28 days
Effect of PRS-080#22-DP on total iron
Changes in total iron concentration in blood compared to baseline
Measured: up to 28 days
Effect of PRS-080#22-DP on transferrin saturation
Changes in transferrin saturation in blood compared to baseline
Measured: up to 28 days
Effect of PRS-080#22-DP on ferritin
Changes to ferritin concentration in blood compared to baseline
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2015 (estimated)
- Study startNov 2014
- Primary completionJul 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pieris Pharmaceuticals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nuvisan Pharma Services, FGK Clinical Research GmbH, EUROCALIN Consortium
- Responsible party
- Sponsor
- Investigators
- Ulrich Moebius, PhD, Study director, Pieris Pharmaceuticals GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02340572
- Sponsor's protocol ID
- PCS_01_12
- Status last verified
- Aug 2015
- First submitted
- 18 Dec 2014
- Last updated
- 10 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02340572
- Acronym / sponsor ID
- PCS_01_12
- Conditions
- Healthy
- Keywords
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Pieris Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Nuvisan Pharma Services, FGK Clinical Research GmbH, EUROCALIN Consortium
- Study start
- Nov 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 16 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRS-080#022-DP | Experimental | Drug: PRS-080#022-DPhepcidin antagonist, single administration, ascending doses |
| PRS-080-Placebo#001 | Placebo comparator | Drug: PRS-080-Placebo#001Comparotor treatment, single administration |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRS-080#022-DPAlso: PRS-080hepcidin antagonist | Drug | PRS-080#022-DP |
| PRS-080-Placebo#001Also: PlaceboPlacebo treatment | Drug | PRS-080-Placebo#001 |
Primary outcome
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
6 secondary outcomes
Pharmacokinetics of PRS-080#22-DP following administration of single doses
Time frame: 14 time points up to 11 days
Assessment of anti-drug antibodies in blood following single administration
Time frame: up to 28 days
Effect of PRS-080#22-DP on hepcidin concentrations in blood
Time frame: 15 time points up to 28 days
Effect of PRS-080#22-DP on total iron
Time frame: up to 28 days
Effect of PRS-080#22-DP on transferrin saturation
Time frame: up to 28 days
Effect of PRS-080#22-DP on ferritin
Time frame: up to 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrich Moebius, PhD study director
Pieris Pharmaceuticals GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PRS-080#022-DP in people with Healthy, run by Pieris Pharmaceuticals GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with adverse events (time frame: up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2015.