SafetyPhase 1PREVAIL1NCT03955666
A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of PRV-3279 in Healthy Subjects
A Phase 1 study of Safety, run by Provention Bio, Inc. at 1 site in United States.
Trial summary
This Phase 1b study will evaluate the safety of PRV-3279 in healthy adult subjects Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2019to 11 Dec 2019
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.
- Body mass index (BMI) 18 to 32 kg/m2, inclusive.
- Male or female 18 to 50 years of age, inclusive.
- Nonpregnant women of childbearing potential (WOCBP) and sexually active men must agree to use effective birth control with male contraception during study participation through at least 3 months after the final dose. Women of non-childbearing potential may participate.
Who cannot join
- Women who are pregnant or breastfeeding.
- Evidence of active or chronic infections.
- Previous exposure to PRV-3279.
- Any reason that, in the opinion of the Investigator, would contraindicate the subject's participation in the study or confound the results of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PREVAIL 1: A Phase 1b, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of PRV-3279 in Healthy Subjects
This Phase 1b study will evaluate the safety of PRV-3279 in healthy adult subjects
Read the detailed description
PRV-3279-1b is a Phase 1b, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of PRV-3279 in Healthy Subjects.
Eligible subjects include healthy male or female adults, 18 to 50 years of age. Each subject will receive the assigned treatment over 29 days followed by a 56-day follow-up period.
- Conditions
- Safety
- Being tested
- PRV-3279 or placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRV-3279 or placeboBiological
bi-specific antibody-based molecule
| Study group | Role | What they receive |
|---|---|---|
| Cohort A (PRV-3279 or placebo) | Experimental | Sterile solution for intravenous administration, 3 doses, every 2 weeks Receives: Biological: PRV-3279 or placebo |
| Cohort B (PRV-3279 or placebo) | Experimental | Sterile solution for intravenous administration, 3 doses, every 2 weeks Receives: Biological: PRV-3279 or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment-emergent adverse events (TEAEs)
Assessment of safety and tolerability
Measured: 85 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start7 Aug 2019
- Primary completion11 Dec 2019
- Study completion11 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SafetyStudies 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
- Model description
- Double-blind, placebo-controlled, multiple ascending dose study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Provention Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, Study director, Provention Bio, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03955666
- Sponsor's protocol ID
- PRV-3279-1b
- Acronym
- PREVAIL1
- Status last verified
- Dec 2019
- First submitted
- 16 May 2019
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREVAIL 1: A Phase 1b, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of PRV-3279 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03955666
- Acronym / sponsor ID
- PREVAIL1 / PRV-3279-1b
- Conditions
- Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Provention Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Aug 2019 (actual)
- Primary completion
- 11 Dec 2019 (actual)
- Study completion
- 11 Dec 2019 (actual)
- First posted
- 20 May 2019 (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 Phase 1b study will evaluate the safety of PRV-3279 in healthy adult subjects
Detailed description
PRV-3279-1b is a Phase 1b, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of PRV-3279 in Healthy Subjects.
Eligible subjects include healthy male or female adults, 18 to 50 years of age. Each subject will receive the assigned treatment over 29 days followed by a 56-day follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, placebo-controlled, multiple ascending dose study
| Arm | Type | Receives |
|---|---|---|
| Cohort A (PRV-3279 or placebo) | Experimental | Biological: PRV-3279 or placeboSterile solution for intravenous administration, 3 doses, every 2 weeks |
| Cohort B (PRV-3279 or placebo) | Experimental | Biological: PRV-3279 or placeboSterile solution for intravenous administration, 3 doses, every 2 weeks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.
- Body mass index (BMI) 18 to 32 kg/m2, inclusive.
- Male or female 18 to 50 years of age, inclusive.
- Nonpregnant women of childbearing potential (WOCBP) and sexually active men must agree to use effective birth control with male contraception during study participation through at least 3 months after the final dose. Women of non-childbearing potential may participate.
Key exclusion criteria (4 listed)
- Women who are pregnant or breastfeeding.
- Evidence of active or chronic infections.
- Previous exposure to PRV-3279.
- Any reason that, in the opinion of the Investigator, would contraindicate the subject's participation in the study or confound the results of the study.
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 |
|---|---|---|
| PRV-3279 or placebobi-specific antibody-based molecule | Biological | Cohort A (PRV-3279 or placebo), Cohort B (PRV-3279 or placebo) |
Primary outcome
Incidence and severity of treatment-emergent adverse events (TEAEs)
Time frame: 85 days
Assessment of safety and tolerability
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 28 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Chief Medical Officer study director
Provention Bio, Inc.
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 of Safety, run by Provention Bio, Inc. 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 4 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 28 Aug 2023. 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?
Incidence and severity of treatment-emergent adverse events (TEAEs) (time frame: 85 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 28 Aug 2023.