HealthyPhase 1NCT04676178
A Study of PRA023 in Healthy Volunteers
A Phase 1 study testing PRA023 in people with Healthy, run by Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 1 site in United States.
Trial summary
This is randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PRA023 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PRA023
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2020to 23 Sep 2021
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female (of non-childbearing potential only) between minimum adult legal age (according to local laws for signing the informed consent document) and 55 years of age.
- Females must be of non-childbearing potential and must have undergone one of the following sterilization procedures, and have official documentation, at least 6 months prior to the first dose:
- hysteroscopic sterilization;
- bilateral tubal ligation or bilateral salpingectomy;
- hysterectomy;
- bilateral oophorectomy, or;
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- be postmenopausal with amenorrhea for at least 1 year prior to the first dose and have FSH serum levels consistent with postmenopausal status as per investigator judgment.
- Male subjects must use reliable forms of contraception during sexual intercourse with female partners from screening to 30 days after the end of dosing.
- Good general health as determined by medical history, and by results of physical examination, chest x-ray, vital signs, ECG, and clinical laboratory tests obtained within 28 days (4 weeks) prior to study drug administration.
Who cannot join
- History or presence of any clinically significant organ system disease that could interfere with the objectives of the study or the safety of the subjects.
- Blood pressure and heart rate are outside the ranges 90-140 mmHg systolic, 60-90 mmHg diastolic, heart rate 60-100 beats/min.
- 12-lead ECG with any abnormality judged by the Investigator to be clinically significant, QRS >= 120 milliseconds (msec), or QTcF interval of > 450 msec for men or >470 msec for women.
- Presence or history of any abnormality or illness, which in the opinion of the Investigator may affect absorption, distribution, metabolism or elimination of the study drug.
- Any screening laboratory evaluation outside the laboratory reference range that is judged by the Investigator to be clinically significant.
- History of or current active tuberculosis (TB) infection; history of latent TB that has not been fully treated or current latent TB infection as indicated by a positive QuantiFERON-TB test.
- History of significant allergy to any medication as judged by the Investigator.
- History of alcohol or drug abuse within the past 24 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetics Study of PRA023 in Healthy Volunteers
This is randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PRA023 in healthy volunteers.
- Conditions
- Healthy
- Being tested
- PRA023, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRA023Drug
PRA023
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| SAD Cohorts 1-6 Experimental Arm | Experimental | Subjects will receive single intravenous doses of PRA023 in a dose escalation format Receives: Drug: PRA023 |
| SAD Cohorts 1-6 Placebo Arm | Placebo comparator | Subjects will receive intravenous doses of placebo Receives: Other: Placebo |
| MAD Cohorts 1-5 Experimental Arm | Experimental | Subjects will receive three intravenous doses of PRA023, one dose every 2 weeks, in a dose escalation format Receives: Drug: PRA023 |
| MAD Cohorts 1-5 Placebo Arm | Placebo comparator | Subjects will receive three intravenous doses of placebo, one dose every 2 weeks, Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment emergent adverse events
Incidence, severity, and causal relationship of TEAEs
Measured: Up to 22 weeks
Secondary outcomes (5)
Cmax
Maximum concentration after single and multiple ascending doses
Measured: Up to 22 weeks
Tmax
Time to reach maximum concentration after single and multiple ascending doses
Measured: Up to 22 weeks
t1/2
Half life after single and multiple ascending doses
Measured: Up to 22 weeks
AUC
Area under the curve after single and multiple ascending doses
Measured: Up to 22 weeks
ADA
Incidence of anti-drug antibody after single and multiple ascending doses
Measured: Up to 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start15 Dec 2020
- Primary completion23 Sep 2021
- Study completion23 Sep 2021
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Responsible party
- Sponsor
- Investigators
- Allison Luo, MD, Study chair, Prometheus Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04676178
- Sponsor's protocol ID
- PR200-101
- Other IDs
- 7240-003
- Status last verified
- Jan 2024
- First submitted
- 9 Dec 2020
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetics Study of PRA023 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04676178
- Acronym / sponsor ID
- PR200-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 23 Sep 2021 (actual)
- Study completion
- 23 Sep 2021 (actual)
- First posted
- 19 Dec 2020 (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 randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PRA023 in healthy volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SAD Cohorts 1-6 Experimental Arm | Experimental | Drug: PRA023Subjects will receive single intravenous doses of PRA023 in a dose escalation format |
| SAD Cohorts 1-6 Placebo Arm | Placebo comparator | Other: PlaceboSubjects will receive intravenous doses of placebo |
| MAD Cohorts 1-5 Experimental Arm | Experimental | Drug: PRA023Subjects will receive three intravenous doses of PRA023, one dose every 2 weeks, in a dose escalation format |
| MAD Cohorts 1-5 Placebo Arm | Placebo comparator | Other: PlaceboSubjects will receive three intravenous doses of placebo, one dose every 2 weeks, |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male or female (of non-childbearing potential only) between minimum adult legal age (according to local laws for signing the informed consent document) and 55 years of age.
- Females must be of non-childbearing potential and must have undergone one of the following sterilization procedures, and have official documentation, at least 6 months prior to the first dose:
- Male subjects must use reliable forms of contraception during sexual intercourse with female partners from screening to 30 days after the end of dosing.
- Good general health as determined by medical history, and by results of physical examination, chest x-ray, vital signs, ECG, and clinical laboratory tests obtained within 28 days (4 weeks) prior to study drug administration.
Key exclusion criteria (8 listed)
- History or presence of any clinically significant organ system disease that could interfere with the objectives of the study or the safety of the subjects.
- Blood pressure and heart rate are outside the ranges 90-140 mmHg systolic, 60-90 mmHg diastolic, heart rate 60-100 beats/min.
- 12-lead ECG with any abnormality judged by the Investigator to be clinically significant, QRS >= 120 milliseconds (msec), or QTcF interval of > 450 msec for men or >470 msec for women.
- Presence or history of any abnormality or illness, which in the opinion of the Investigator may affect absorption, distribution, metabolism or elimination of the study drug.
- Any screening laboratory evaluation outside the laboratory reference range that is judged by the Investigator to be clinically significant.
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 |
|---|---|---|
| PRA023PRA023 | Drug | MAD Cohorts 1-5 Experimental Arm, SAD Cohorts 1-6 Experimental Arm |
| PlaceboPlacebo | Other | MAD Cohorts 1-5 Placebo Arm, SAD Cohorts 1-6 Placebo Arm |
Primary outcome
Treatment emergent adverse events
Time frame: Up to 22 weeks
Incidence, severity, and causal relationship of TEAEs
5 secondary outcomes
Cmax
Time frame: Up to 22 weeks
Tmax
Time frame: Up to 22 weeks
t1/2
Time frame: Up to 22 weeks
AUC
Time frame: Up to 22 weeks
ADA
Time frame: Up to 22 weeks
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 17 Jan 2024.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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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.
Allison Luo, MD study chair
Prometheus 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 PRA023 in people with Healthy, run by Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) 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 9 inclusion and 8 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 17 Jan 2024. 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?
Treatment emergent adverse events (time frame: Up to 22 weeks). 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 17 Jan 2024.