PsoriasisPhase 1NCT02458677
Single Ascending Dose Study of PRX003 in Healthy Subjects
A Phase 1 study testing PRX003 in people with Psoriasis, run by Prothena Biosciences Limited at 1 site in United States.
Trial summary
This single ascending dose study is to determine safety, tolerability, pharmacokinetics and immunogenicity of PRX003 in approximately 40 healthy subjects. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- PRX003
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Feb 2016
- 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 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects
- Body mass index (BMI) between 18-32 kg/m2 with a minimum weight of 45 kg
- Female subjects must be surgically sterile or post-menopausal or if of child-bearing potential must use contraception
- Male subjects and their partners of childbearing potential must use contraception
Who cannot join
- Positive test for drug of abuse
- Past or current history of alcohol abuse
- Positive for TB, hepatitis B, hepatitis C or HIV infection
Trial locations and contacts
1 site in 1 country.
United States1 site
Worldwide Clinical Trials Early Phase Services
San Antonio, Texas
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of PRX003 Administered by Intravenous Infusion in Healthy Subjects
This single ascending dose study is to determine safety, tolerability, pharmacokinetics and immunogenicity of PRX003 in approximately 40 healthy subjects.
- Conditions
- Psoriasis
- Being tested
- PRX003, Placebo
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRX003Drug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| PRX003 | Experimental | Not described Receives: Drug: PRX003 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability as determined by number of subjects with adverse events
Measured: Up to 3 months
Determination of pharmacokinetics parameters-(Cmax)
maximum concentration (Cmax)
Measured: Up to 3 months
Determination of pharmacokinetics parameters-(AUClast)
area under the concentration-time curve from time zero to the last quantifiable concentration time-point (AUClast)
Measured: Up to 3 months
Determination of pharmacokinetics parameters-(AUCinf)
area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)
Measured: Up to 3 months
Determination of pharmacokinetics parameters-elimination rate constant
elimination rate constant
Measured: Up to 3 months
Determination of pharmacokinetics parameters-(t½)
terminal elimination half life (t½)
Measured: Up to 3 months
Determination of pharmacokinetics parameters-(CL)
clearance (CL)
Measured: Up to 3 months
Determination of pharmacokinetics parameters-(Vd)
apparent volume of distribution (Vd)
Measured: Up to 3 months
Secondary outcomes (1)
Immunogenicity as determined by measurement of anti-PRX003 antibodies
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prothena Biosciences Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02458677
- Sponsor's protocol ID
- PRX003-CL001
- Status last verified
- Mar 2016
- First submitted
- 28 May 2015
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of PRX003 Administered by Intravenous Infusion in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02458677
- Acronym / sponsor ID
- PRX003-CL001
- Conditions
- Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Prothena Biosciences LimitedIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 1 Jun 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.
This single ascending dose study is to determine safety, tolerability, pharmacokinetics and immunogenicity of PRX003 in approximately 40 healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRX003 | Experimental | Drug: PRX003 |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy subjects
- Body mass index (BMI) between 18-32 kg/m2 with a minimum weight of 45 kg
- Female subjects must be surgically sterile or post-menopausal or if of child-bearing potential must use contraception
- Male subjects and their partners of childbearing potential must use contraception
Key exclusion criteria (3 listed)
- Positive test for drug of abuse
- Past or current history of alcohol abuse
- Positive for TB, hepatitis B, hepatitis C or HIV infection
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 |
|---|---|---|
| PRX003 | Drug | PRX003 |
| Placebo | Other | Placebo |
Primary outcome
Safety and tolerability as determined by number of subjects with adverse events
Time frame: Up to 3 months
Determination of pharmacokinetics parameters-(Cmax)
Time frame: Up to 3 months
maximum concentration (Cmax)
Determination of pharmacokinetics parameters-(AUClast)
Time frame: Up to 3 months
area under the concentration-time curve from time zero to the last quantifiable concentration time-point (AUClast)
Determination of pharmacokinetics parameters-(AUCinf)
Time frame: Up to 3 months
area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)
Determination of pharmacokinetics parameters-elimination rate constant
Time frame: Up to 3 months
elimination rate constant
Determination of pharmacokinetics parameters-(t½)
Time frame: Up to 3 months
terminal elimination half life (t½)
Determination of pharmacokinetics parameters-(CL)
Time frame: Up to 3 months
clearance (CL)
Determination of pharmacokinetics parameters-(Vd)
Time frame: Up to 3 months
apparent volume of distribution (Vd)
1 secondary outcome
Immunogenicity as determined by measurement of anti-PRX003 antibodies
Time frame: Up to 3 months
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 16 Mar 2016.
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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 PRX003 in people with Psoriasis, run by Prothena Biosciences Limited at 1 site in United States.
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 3 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 16 Mar 2016. 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 United States. 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?
Safety and tolerability as determined by number of subjects with adverse events (time frame: Up to 3 months). The study lists 8 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 16 Mar 2016.