Prostatic NeoplasmsPhase 1NCT04839120
PK, PD, Tolerability and Safety of MDPK67b in Healthy Volunteers
A Phase 1 study testing MDPK67b in people with Prostatic Neoplasms, run by Med Discovery SA at 1 site in Switzerland.
Trial summary
This is a Phase I, single centre, prospective, randomized, alternating panels, ascending doses with interspersed placebo, double-blind, crossover trial. The trial will include 8 volunteers divided into 2 panels (A and B) investigated in alternance, each submitted to 4 investigation periods following a crossover design… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- MDPK67b
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteSwitzerland
- Study dates
- 21 Feb 2017to 7 Jun 2017
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects aged between 18 and 45 years
- Body weight (BW) ranging between 55 and 95 kg, providing body mass index (BMI) is between 18 and 29 kg/m2
- Absence of significant findings in the medical history and physical examination as judged by the investigator, especially for cardiovascular, pulmonary, haematological and nervous systems
- Absence of significant laboratory abnormalities as judged by the investigator. Gilbert's syndrome (increased total and unconjugated bilirubin when fasting) will be accepted if mild
- 12-lead ECG without significant abnormalities
- Negative urine drug screen (amphetamines, benzodiazepines, cannabis, cocaine, opiates)
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- Negative alcohol breath test
- Ability to understand the procedures, agreement to participate and willingness to give written informed consent
- Co-operative attitude and availability for scheduled visits over the entire study period.
- The subjects will have to refrain from travels outside Europe over the whole study duration.
Who cannot join
- History of major cardiovascular, pulmonary, hepatic, immunological, renal, haematological, gastrointestinal, genitourinary, neurological, or rheumatologic disorders
- Active diseases of any type, including inflammatory disorders and infections. Mild acne is permissible providing no systemic or local treatment is provided or planned (except for cleaning lotions)
- History of significant allergy or asthma. Allergic rhinitis or conjunctivitis is acceptable if non symptomatic when starting the study and if symptoms are not anticipated to occur during the study to a point that would require corticosteroid therapy (e.g. in case of annual use)
- History of cardiovascular dysfunction if considered as clinically relevant (conduction abnormality, arrhythmia, bradycardia, angina pectoris, cardiac hypertrophy unless elicited by training, pulmonary embolism)
- Hypertension defined as supine blood pressure >150/90 mmHg or recurrent hypotensive events considered as clinically relevant or documented orthostatic hypotension
- Any clinically significant coagulation disorder, based on either clinical manifestations (abnormal bleeding etc.) or abnormal laboratory values (platelet count, TP, aPTT, Thrombin time and fibrinogen).
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- Sick sinus syndrome, known long QT syndrome, reproducible observation of QTc >440 ms or of pronounced sinus bradycardia (<40 bpm)
- Intense sport activities. Moderate sport is acceptable and activities should remain fairly constant throughout the study
- Any clinically significant laboratory value on screening that are not within normal range on single repeat (Gilbert's syndrome acceptable if mild)
- Positive hepatitis B or C antigen screen
- Positive HIV antibody screen or screen not performed
- Any recent acute illness or sequelae thereof which could expose the subject to a higher risk or might confound the results of the study
- Treatment in the previous three months with any drug known to have well-defined potential for toxicity to a major organ
- History of hypersensitivity to any drug if considered as serious
- Use of any medication the week prior to study or as based on 5 serum half-life rule and throughout study, including aspirin or other over-the-counter (OTC) preparation. Paracetamol is permissible before and during study as a rescue medication but only with investigator's permission.
- Participation in a clinical investigation or blood donation of 500 ml within the past 3 months
- History of relevant alcohol or drug abuse
- Smoking. Consumption of ≤5 cigarettes/day or equivalent is acceptable providing the subject can refrain from smoking from one week before and during the whole study duration
- Consumption of a large quantity of coffee, tea, chocolate (more than 4 cups/day) or equivalent (Cola drinks)
- Present consumption of a large quantity of alcohol or wine (>0.5 L wine/day) or equivalent, (equivalent to more than 35 g ethanol per day).
- Psychological status which could impact on subject's ability to give informed consent
- Any feature of subject's medical history or present condition which, in the investigator's opinion, could confound the results of the study, complicate its interpretation, or represent a potential risk for the subject.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois (CHUV) - Division of Clinical Pharmacology
Lausanne
About this study
Official title: Phase I Clinical Trial of the KLK Inhibitor MDPK67b to Assess Its Pharmacokinetic, Pharmacodynamic, Tolerability and Safety Profile in Healthy Male Volunteers
This is a Phase I, single centre, prospective, randomized, alternating panels, ascending doses with interspersed placebo, double-blind, crossover trial.
The trial will include 8 volunteers divided into 2 panels (A and B) investigated in alternance, each submitted to 4 investigation periods following a crossover design in double blind, with ascending intravenous doses of MDPK67b and an interspersed placebo.
The ascending dose sequence ranges from 2 to 48 mg, with 2-fold increase steps (3 to 4- fold increase steps in each individual volunteer). Three single doses will be administered at a minimum of 2 weeks intervals during the first 3 periods, and finally during the last period 4 repeated doses will be administered at a three days intervals, using either the highest dose of the ascending sequence (i.e. 24 or 48 mg) or the maximal tolerated dose (if it has been exceeded in the ascending sequence of single doses).
- Conditions
- Prostatic Neoplasms
- Being tested
- MDPK67b, Placebo
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDPK67bDrug
Two subgroups (Panels A and Panel B) of four subjects were to be randomly allocated either to placebo or to three increasing doses of MDPK67b, administered as single infusion at intervals of at least two weeks during the first three periods with the last period involving four repeated doses administered at three-day intervals.
PlaceboDrug
Two subgroups (Panel A and Panel B) of four subjects were to be randomly allocated either to placebo or to three increasing doses of MDPK67b, administered as single infusion at intervals of at least two weeks during the first three periods with the last period involving four repeated doses administered at three-day intervals.
| Study group | Role | What they receive |
|---|---|---|
| MDPK67b | Active comparator | Not described Receives: Drug: MDPK67b |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs)
Subjects were assessed for AEs at each visit.
Measured: Week 8
MDPK67b serum level
Serum concentrations of MDPK67b were measured using an ELISA method.
Measured: Up to 144 hours after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start21 Feb 2017
- Primary completion7 Jun 2017
- Study completion7 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Med Discovery SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04839120
- Sponsor's protocol ID
- MDPK67b-1001
- Status last verified
- Apr 2021
- First submitted
- 29 Mar 2021
- Last updated
- 9 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial of the KLK Inhibitor MDPK67b to Assess Its Pharmacokinetic, Pharmacodynamic, Tolerability and Safety Profile in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT04839120
- Acronym / sponsor ID
- MDPK67b-1001
- Conditions
- Prostatic Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Med Discovery SAIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2017 (actual)
- Primary completion
- 7 Jun 2017 (actual)
- Study completion
- 7 Jun 2017 (actual)
- First posted
- 9 Apr 2021 (actual)
- 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.
This is a Phase I, single centre, prospective, randomized, alternating panels, ascending doses with interspersed placebo, double-blind, crossover trial.
The trial will include 8 volunteers divided into 2 panels (A and B) investigated in alternance, each submitted to 4 investigation periods following a crossover design in double blind, with ascending intravenous doses of MDPK67b and an interspersed placebo.
The ascending dose sequence ranges from 2 to 48 mg, with 2-fold increase steps (3 to 4- fold increase steps in each individual volunteer). Three single doses will be administered at a minimum of 2 weeks intervals during the first 3 periods, and finally during the last period 4 repeated doses will be administered at a three days intervals, using either the highest dose of the ascending sequence (i.e. 24 or 48 mg) or the maximal tolerated dose (if it has been exceeded in the ascending sequence of single doses).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MDPK67b | Active comparator | Drug: MDPK67b |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy male subjects aged between 18 and 45 years
- Body weight (BW) ranging between 55 and 95 kg, providing body mass index (BMI) is between 18 and 29 kg/m2
- Absence of significant findings in the medical history and physical examination as judged by the investigator, especially for cardiovascular, pulmonary, haematological and nervous systems
- Absence of significant laboratory abnormalities as judged by the investigator. Gilbert's syndrome (increased total and unconjugated bilirubin when fasting) will be accepted if mild
- 12-lead ECG without significant abnormalities
Key exclusion criteria (22 listed)
- History of major cardiovascular, pulmonary, hepatic, immunological, renal, haematological, gastrointestinal, genitourinary, neurological, or rheumatologic disorders
- Active diseases of any type, including inflammatory disorders and infections. Mild acne is permissible providing no systemic or local treatment is provided or planned (except for cleaning lotions)
- History of significant allergy or asthma. Allergic rhinitis or conjunctivitis is acceptable if non symptomatic when starting the study and if symptoms are not anticipated to occur during the study to a point that would require corticosteroid therapy (e.g. in case of annual use)
- History of cardiovascular dysfunction if considered as clinically relevant (conduction abnormality, arrhythmia, bradycardia, angina pectoris, cardiac hypertrophy unless elicited by training, pulmonary embolism)
- Hypertension defined as supine blood pressure >150/90 mmHg or recurrent hypotensive events considered as clinically relevant or documented orthostatic hypotension
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 |
|---|---|---|
| MDPK67bTwo subgroups (Panels A and Panel B) of four subjects were to be randomly allocated either to placebo or to three increasing doses of MDPK67b, administered as single infusion at intervals of at least two weeks during the first three periods with the last period involving four repeated doses administered at three-day intervals. | Drug | MDPK67b |
| PlaceboTwo subgroups (Panel A and Panel B) of four subjects were to be randomly allocated either to placebo or to three increasing doses of MDPK67b, administered as single infusion at intervals of at least two weeks during the first three periods with the last period involving four repeated doses administered at three-day intervals. | Drug | Placebo |
Primary outcome
Incidence of Adverse Events (AEs)
Time frame: Week 8
Subjects were assessed for AEs at each visit.
MDPK67b serum level
Time frame: Up to 144 hours after drug administration
Serum concentrations of MDPK67b were measured using an ELISA method.
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 9 Apr 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 MDPK67b in people with Prostatic Neoplasms, run by Med Discovery SA at 1 site in Switzerland.
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 10 inclusion and 22 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 9 Apr 2021. 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 Switzerland. 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?
Incidence of Adverse Events (AEs) (time frame: Week 8). The study lists 2 primary outcomes in all. 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 9 Apr 2021.