HealthyPhase 1NCT05354349
Bioavailability of SC Formulation and Japanese Ethnobridging Study for PRA023
A Phase 1 study testing PRA023 IV Low Dose, PRA023 SC and PRA023 IV High Dose 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 a randomized double-blind, placebo-controlled, single-dose study to evaluate the safety, tolerability, and pharmacokinetics of PRA023 in healthy Caucasian and Japanese adult 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 IV Low Dose, PRA023 SC and PRA023 IV High Dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2022to 31 Aug 2022
- 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
- Subjects are required to meet the following criteria in order to be included in the study:
- Japanese subjects must have both natural (not adopted) parents and four grandparents of Japanese origin.
- Caucasian subjects must be of European or Latin American descent (i.e., White).
- 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;
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- bilateral tubal ligation or bilateral salpingectomy;
- hysterectomy;
- bilateral oophorectomy, or;
- 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
- Subjects with the following characteristics will be excluded from the study:
- 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, 60-90mmHg 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 > 470msec 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.
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- 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.
United States1 site
Altasciences Clinical LA, Inc.
Cypress, California, 90630
About this study
Official title: A Phase 1, Double-Blind, Placebo-Controlled, Single-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PRA023 in Healthy Caucasian and Japanese Adult Volunteers
This is a randomized double-blind, placebo-controlled, single-dose study to evaluate the safety, tolerability, and pharmacokinetics of PRA023 in healthy Caucasian and Japanese adult volunteers
- Conditions
- Healthy
- Being tested
- PRA023 IV Low Dose, PRA023 SC, Placebo IV, Placebo SC, PRA023 IV High Dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRA023 IV Low DoseDrug
Drug
PRA023 SCDrug
Drug
Placebo IVDrug
Placebo
Placebo SCDrug
Placebo
PRA023 IV High DoseDrug
Drug
| Study group | Role | What they receive |
|---|---|---|
| PRA023 SC/Placebo IV | Experimental | Participants randomized to receive active subcutaneous injection/placebo intravenous infusion Receives: Drug: PRA023 SC; Drug: Placebo IV |
| Placebo SC/PRA023 IV Low Dose | Active comparator | Participants randomized to receive placebo subcutaneous injection/active intravenous infusion Receives: Drug: PRA023 IV Low Dose; Drug: Placebo SC |
| Placebo SC/Placebo IV | Placebo comparator | Participants randomized to receive placebo subcutaneous injection/placebo intravenous infusion Receives: Drug: Placebo IV; Drug: Placebo SC |
| Placebo SC/PRA023 IV High Dose | Experimental | Not described Receives: Drug: Placebo SC; Drug: PRA023 IV High Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, severity, causal relationship of treatment emergent adverse events
Measured: Up to 14 Weeks
F% in Caucasian subjects
Mean SC versus IV AUC(inf) values
Measured: Up to 10 Weeks
Cmax in Japanese subjects
Maximum concentration after single dose
Measured: Up to 14 Weeks
Tmax in Japanese subjects
Time to reach maximum concentration after single dose
Measured: Up to 14 Weeks
Secondary outcomes (4)
Cmax in Caucasian subjects
Maximum concentration after single dose
Measured: Up to 10 Weeks
Tmax in Caucasian subjects
Time to reach maximum concentration after single dose
Measured: Up to 10 Weeks
Immunogenicity rate
Measured: Up to 14 Weeks
Change in sTL1A levels
Measured: Up to 14 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start6 Apr 2022
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 49 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
- Altasciences Company Inc.
- Responsible party
- Sponsor
- Investigators
- Prometheus Biosciences, Study director, Clinicaltrials Call Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05354349
- Sponsor's protocol ID
- PR200-105
- Other IDs
- 7240-004
- Status last verified
- Jan 2024
- First submitted
- 1 Apr 2022
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-Blind, Placebo-Controlled, Single-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PRA023 in Healthy Caucasian and Japanese Adult Volunteers
- ClinicalTrials.gov ID
- NCT05354349
- Acronym / sponsor ID
- PR200-105
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
- Collaborators
- Altasciences Company Inc.
- Study start
- 6 Apr 2022 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 29 Apr 2022 (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 randomized double-blind, placebo-controlled, single-dose study to evaluate the safety, tolerability, and pharmacokinetics of PRA023 in healthy Caucasian and Japanese adult volunteers
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PRA023 SC/Placebo IV | Experimental | Drug: PRA023 SC, Drug: Placebo IVParticipants randomized to receive active subcutaneous injection/placebo intravenous infusion |
| Placebo SC/PRA023 IV Low Dose | Active comparator | Drug: PRA023 IV Low Dose, Drug: Placebo SCParticipants randomized to receive placebo subcutaneous injection/active intravenous infusion |
| Placebo SC/Placebo IV | Placebo comparator | Drug: Placebo IV, Drug: Placebo SCParticipants randomized to receive placebo subcutaneous injection/placebo intravenous infusion |
| Placebo SC/PRA023 IV High Dose | Experimental | Drug: Placebo SC, Drug: PRA023 IV High Dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Subjects are required to meet the following criteria in order to be included in the study:
Key exclusion criteria (9 listed)
- Subjects with the following characteristics will be excluded from 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 |
|---|---|---|
| PRA023 IV Low DoseDrug | Drug | Placebo SC/PRA023 IV Low Dose |
| PRA023 SCDrug | Drug | PRA023 SC/Placebo IV |
| Placebo IVPlacebo | Drug | PRA023 SC/Placebo IV, Placebo SC/Placebo IV |
| Placebo SCPlacebo | Drug | Placebo SC/PRA023 IV High Dose, Placebo SC/PRA023 IV Low Dose, Placebo SC/Placebo IV |
| PRA023 IV High DoseDrug | Drug | Placebo SC/PRA023 IV High Dose |
Primary outcome
Incidence, severity, causal relationship of treatment emergent adverse events
Time frame: Up to 14 Weeks
F% in Caucasian subjects
Time frame: Up to 10 Weeks
Mean SC versus IV AUC(inf) values
Cmax in Japanese subjects
Time frame: Up to 14 Weeks
Maximum concentration after single dose
Tmax in Japanese subjects
Time frame: Up to 14 Weeks
Time to reach maximum concentration after single dose
4 secondary outcomes
Cmax in Caucasian subjects
Time frame: Up to 10 Weeks
Tmax in Caucasian subjects
Time frame: Up to 10 Weeks
Immunogenicity rate
Time frame: Up to 14 Weeks
Change in sTL1A levels
Time frame: Up to 14 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 16 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.
Prometheus Biosciences study director
Clinicaltrials Call Center
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 IV Low Dose, PRA023 SC and PRA023 IV High Dose 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 12 inclusion and 9 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 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?
Incidence, severity, causal relationship of treatment emergent adverse events (time frame: Up to 14 Weeks). The study lists 4 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 Jan 2024.