Healthy Participants StudyPhase 1NCT06699680
Phase 1 Study of PRX019 in Healthy Adult Volunteers
A Phase 1 study testing PRX019 in people with Healthy Participants Study, run by Prothena Biosciences Ltd. at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety and tolerability of PRX019 in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants Study
- What is being tested?
- PRX019
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2024to 16 Jan 2026
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female participants who are healthy as determined by the investigator based on review of medical history, physical examination, and clinical laboratory tests obtained during the screening period
- Participant is willing and able to adhere to the study visit schedule and other protocol requirements
Who cannot join
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, or clinical laboratory tests beyond what is consistent with a healthy population in the region in which the study is conducted
- Participant was exposed to an investigational drug (new chemical entity) within 90 days preceding the first dose administration, or within 7 times the elimination half-life, if known (whichever is longer)
- NOTE: Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Sponsor-Open, Placebo Controlled, First In Human Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of Single Ascending and Multiple Doses of PRX019 in Healthy Adults
The purpose of this study is to assess the safety and tolerability of PRX019 in healthy adult participants.
- Conditions
- Healthy Participants Study
- Being tested
- PRX019, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRX019Drug
Specified dose on specified days
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| PRX019, single dose | Experimental | Specified dose on specified days Receives: Drug: PRX019; Drug: Placebo |
| PRX019, multiple dose | Experimental | Specified dose on specified days Receives: Drug: PRX019; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Measured: Up to 6 months
Number of participants with clinical laboratory assessment abnormalities
Measured: Up to 6 months
Secondary outcomes (6)
Maximum observed plasma concentration (Cmax)
Measured: Up to 6 months
Time to the maximum measured plasma concentration (Tmax)
Measured: Up to 6 months
Area under the concentration-time curve from time 0 through the intended dosing interval (AUCͳ)
Measured: Up to 6 months
Terminal elimination half-life in plasma (t1/2)
Measured: Up to 6 months
Maximum observed plasma concentration at steady state (Cmax,ss)
Measured: Up to 6 months
Area under the concentration-time curve from time 0 through the intended dosing interval at steady state (AUCͳ,ss)
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start8 Nov 2024
- Primary completion16 Jan 2026
- Study completion16 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Participants StudyStudies 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prothena Biosciences Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chad Swanson, Study director, Prothena Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699680
- Sponsor's protocol ID
- PRX019-101
- Status last verified
- May 2026
- First submitted
- 28 Oct 2024
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Sponsor-Open, Placebo Controlled, First In Human Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of Single Ascending and Multiple Doses of PRX019 in Healthy Adults
- ClinicalTrials.gov ID
- NCT06699680
- Acronym / sponsor ID
- PRX019-101
- Conditions
- Healthy Participants Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Prothena Biosciences Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Nov 2024 (actual)
- Primary completion
- 16 Jan 2026 (actual)
- Study completion
- 16 Jan 2026 (actual)
- First posted
- 21 Nov 2024 (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.
The purpose of this study is to assess the safety and tolerability of PRX019 in healthy adult participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRX019, single dose | Experimental | Drug: PRX019, Drug: PlaceboSpecified dose on specified days |
| PRX019, multiple dose | Experimental | Drug: PRX019, Drug: PlaceboSpecified dose on specified days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male and female participants who are healthy as determined by the investigator based on review of medical history, physical examination, and clinical laboratory tests obtained during the screening period
- Participant is willing and able to adhere to the study visit schedule and other protocol requirements
Key exclusion criteria (3 listed)
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, or clinical laboratory tests beyond what is consistent with a healthy population in the region in which the study is conducted
- Participant was exposed to an investigational drug (new chemical entity) within 90 days preceding the first dose administration, or within 7 times the elimination half-life, if known (whichever is longer)
- NOTE: Other protocol-defined inclusion/exclusion criteria apply
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 |
|---|---|---|
| PRX019Specified dose on specified days | Drug | PRX019, multiple dose, PRX019, single dose |
| PlaceboPlacebo | Drug | PRX019, multiple dose, PRX019, single dose |
Primary outcome
Number of participants with adverse events
Time frame: Up to 6 months
Number of participants with clinical laboratory assessment abnormalities
Time frame: Up to 6 months
6 secondary outcomes
Maximum observed plasma concentration (Cmax)
Time frame: Up to 6 months
Time to the maximum measured plasma concentration (Tmax)
Time frame: Up to 6 months
Area under the concentration-time curve from time 0 through the intended dosing interval (AUCͳ)
Time frame: Up to 6 months
Terminal elimination half-life in plasma (t1/2)
Time frame: Up to 6 months
Maximum observed plasma concentration at steady state (Cmax,ss)
Time frame: Up to 6 months
Area under the concentration-time curve from time 0 through the intended dosing interval at steady state (AUCͳ,ss)
Time frame: Up to 6 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 14 May 2026.
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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.
Chad Swanson study director
Prothena Biosciences
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 PRX019 in people with Healthy Participants Study, run by Prothena Biosciences Ltd. 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 2 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 14 May 2026. 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. 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 participants with adverse events (time frame: Up to 6 months). 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 14 May 2026.