Primary Biliary CholangitisPhase 1/2NCT05104853
Study to Evaluate the Safety, Tolerability, PDs, and Efficacy of CNP-104 in Subjects With Primary Biliary Cholangitis
A Phase 1/2 study testing CNP-104 in people with Primary Biliary Cholangitis, run by COUR Pharmaceutical Development Company, Inc. at 19 sites in United States.
Trial summary
This study is a Phase 2a First-in-Human (FIH) clinical trial to assess the safety, tolerability, pharmacodynamics (PD), and efficacy of multiple ascending doses of CNP-104. The study consists of a 120 day primary study followed by a 20 month long-term safety and durability of response follow-up period. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Biliary Cholangitis
- What is being tested?
- CNP-104
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 19 sitesUnited States
- Study dates
- 25 Jan 2022to 30 Jan 2026
- Phase
- Phase 1/2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who are willing and able to provide Institutional Review Board (IRB) approved written informed consent and privacy language as per national regulations.
- Men and non-pregnant women, ages 18-75 years inclusive.
- Subjects with a PBC diagnosis as demonstrated by the presence of 2 or more of the following 3 diagnostic factors:
- Alkaline phosphatase > 1.5× ULN for at least 6 months
- Positive AMA titer or, if AMA negative or in low titer (<1:40), positive PBC-specific antibodies (anti-GP210 and/or anti-SP100 and/or antibodies against the major M2 components [PDC-E2, 2-oxo-glutaric acid dehydrogenase complex])
- Liver biopsy findings consistent with PBC
Show all 15Show fewer
- Subjects who are unresponsive to UDCA and/or OCA after 6 months of treatment at a stable dose as measured by ALP > 1.5× ULN.
- For subjects on any medication used to treat the symptoms of PBC (ex. UDCA, OCA, seladelpar), subjects must be on a stable dose for a minimum of 3 months prior to enrollment and must agree not to change their dose through study Day 60 unless reviewed by the medical monitor and approved by the site investigator.
- Subjects with ALP > 1.5× ULN.
- Subjects with AST and ALT < 5× ULN.
- Subjects with hemoglobin ≥ 10 g/dL.
- Subjects with total bilirubin < 2× ULN.
- Men and women of child-bearing potential (WOCBP) must agree to practice a highly effective method of contraception that may include, but is not limited to, abstinence, sex only with persons of the same sex, monogamous relationship with vasectomized partner, vasectomy, hysterectomy, bilateral tubal ligation, licensed hormonal methods, intrauterine device (IUD) beginning at the time of screening through Day 90.
- Female subjects who agree not to donate ova starting at initial screening and through Day 90.
- Male subjects who agree to not donate sperm starting at screening and through Day 90.
Who cannot join
- Subjects with a Class B or Class C Child-Pugh score.
- Subjects with concomitant liver diseases including chronic viral hepatitis B or C, autoimmune hepatitis, PSC, alcoholic liver disease, Wilson's disease, hemochromatosis, or Gilbert's syndrome.
- Subjects who have previously undergone liver transplantation.
- Subjects with decompensated liver disease as defined by the presence or history of any of the following:
- MELD score > 15
- Hepatic encephalopathy
Show all 35Show fewer
- Ascites
- Hepatorenal syndrome or serum creatinine > 2 mg/dL
- Total Bilirubin > 3.0 mg/dL
- INR >1.8 unless on anticoagulation such as Coumadin
- History of variceal hemorrhage
- Subjects with a history of cerebrovascular accident in the past 12 months.
- Subjects with history of myocardial infarction, as defined by any of the following criteria:
- Development of pathological Q waves with or without symptoms
- Imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause
- Pathological findings of a healed or healing myocardial
- Subjects with chronic kidney disease, as defined by estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 for at least 3 months (per CKD EPI Equation - 2021).
- Subjects with uncontrolled diabetes, as defined by HbA1c > 7%.
- Subjects who have used the following medications:
- Methotrexate within 90 days of screening.
- Immunotherapy drugs unless approved by the medical monitor.
- Subjects with a history of tuberculosis or positive PPD skin test.
- Subjects who have received administration of any live vaccine (other than intranasal Influenza) within 28 days or subunit vaccine within 14 days prior to screening or are planning to receive any vaccination before Day 90.
- Subjects who have used systemic steroids within 3 months prior to screening.
- Subjects with laboratory test results at screening or prior to study dosing that are outside the normal limits and considered by the Investigator to be clinically significant.
- Note: This criterion does not apply to liver function tests. Additionally, clinically significant laboratory test results at screening that are related to the condition (PBC) are acceptable as long as all inclusion and no other exclusion criteria are met.
- Subjects with positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen/antibody as determined at screening.
- Subjects with a history of or currently active immune disorders other that PBC (including autoimmune disease) unless the condition, after discussion with the Medical Monitor, has been deemed to be acceptable for the subject's participation in this study.
- Subjects with a history of or current active diseases requiring immunosuppressive drugs (including azathioprine, prednisone, prednisolone, budesonide, cyclosporine, tacrolimus, methotrexate, or mycophenolate mofetil) unless the condition, after discussion with the Medical Monitor, has been deemed to be acceptable for the subject's participation in this study.
- Subjects with a clinical history of significant cardiovascular disease as determined by the Investigator.
- Subjects with a complication or medical history of malignancy within past 5 years which, in the Investigator's opinion, makes the subject unsuitable for study participation.
- Subjects who, in the Investigator's opinion, will be unable to adhere to study procedures.
- Subjects who have received an investigational therapy other than CNP-104 within 28 days or 5 half-lives, whichever is longer, prior to screening.
- Subjects with any condition which, in the Investigator's opinion, makes the subject unsuitable for study participation.
- Known sensitivity to any components of CNP-104.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Digestive Healthcare of Georgia
Atlanta, Georgia, 30309
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Virginia
Charlottesville, Virginia, 22903
University of Chicago Medical Center
Chicago, Illinois, 60637
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80907
Southern California Research Center
Coronado, California, 92118
Duke University Medical Center
Durham, North Carolina, 27710
University of Florida - Hepatology Research
Gainesville, Florida, 32610
Mayo Clinic Florida
Jacksonville, Florida, 32224
Florida Research Institute
Lakewood Rch, Florida, 34211-4930
OM Research
Lancaster, California, 93534
GI PROS Research
Naples, Florida, 34102
Yale School of Medicine
New Haven, Connecticut, 06520
Henry Ford Health System
Novi, Michigan, 48377
University of California Davis Health
Sacramento, California, 95817
Texas Liver Institute
San Antonio, Texas, 78215
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63110
Montefiore Medical Center
The Bronx, New York, 10467
Cleveland Clinic - Florida
Weston, Florida, 33331
About this study
Official title: A Phase 2a Double Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Efficacy of CNP-104 in Subjects Ages 18-75 With Primary Biliary Cholangitis Who Are Unresponsive to UDCA and/or OCA
This study is a Phase 2a First-in-Human (FIH) clinical trial to assess the safety, tolerability, pharmacodynamics (PD), and efficacy of multiple ascending doses of CNP-104. The study consists of a 120 day primary study followed by a 20 month long-term safety and durability of response follow-up period.
Read the detailed description
Subjects ages 18-75 with primary biliary cholangitis will be screened up to 14 days prior to enrollment into the study. Screening will be completed to assess eligibility, obtain vital signs, collect laboratory samples and PD measurements, and to receive a FibroScan for liver fibrosis. Subjects will additionally complete an initial PBC-40 assessment and begin an Itch Diary, a questionnaire and scoring system to be completed by the patient every morning and evening through Day 120 and then monthly through end of study.
Subjects who meet all inclusion and no exclusion criteria after completing the screening visit will be enrolled in the study. Subjects will be randomized on Day 1 in a 1:1 ratio to receive either CNP-104 or Placebo (0.9% Sodium Chloride USP) by intravenous (IV) infusion. Subjects will be administered CNP-104 or Placebo on Day 1 and on Day 8. This study was originally designed with 2 cohorts, Cohort 1 comprised of 6 subjects randomized 1:1 to placebo or 4 mg/kg, and Cohort 2 comprised of up to 34 subjects randomized 1:1 to placebo or 8 mg/kg. Under Protocol Amendment 6 (v7.0), the remaining subjects for Cohort 2 (approximately 16) will be randomized 1:3:1 to placebo, 4 mg/kg, and 8 mg/kg respectively.
Subjects will remain in the clinic on Day 1 and Day 8 from the time of admission (prior to administration of CNP-104 or Placebo) through the final procedure conducted 4 hours post-dose that same day unless an infusion reaction, or other adverse event, requires an extended duration of monitoring. Subjects will be discharged if safety parameters are acceptable to the investigator.
Seven days after the second administration of CNP-104 or Placebo, subjects must return to the clinic for collection of safety labs, PD measurements, and assessment of AEs and medication changes.
Subjects will continue to be followed for 2 years to assess safety, pharmacodynamics, and immunogenicity during the Post-Dosing period.
- Conditions
- Primary Biliary Cholangitis
- Being tested
- CNP-104, Placebo
- Medical subject headings
- Liver Cirrhosis, Biliary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CNP-104Drug
CNP-104 is comprised of PDC-E2 peptide dispersed within a negatively charged polymer matrix of poly (lactic-co-glycolic acid) (PLGA) particles at a target concentration of ~1 μg of PDC-E2 peptide per mg of PLGA particles.
PlaceboDrug
CNP-104 Placebo
| Study group | Role | What they receive |
|---|---|---|
| 4 mg/Kg CNP-104 | Experimental | 200 mL intravenous infusion on Day 1 and Day 8: 4 mg/Kg CNP-104 Receives: Drug: CNP-104 |
| 8 mg/Kg CNP-104 | Experimental | 200 mL intravenous infusion on Day 1 and Day 8: 8 mg/Kg CNP-104 Receives: Drug: CNP-104 |
| Placebo | Placebo comparator | 200 mL intravenous infusion on Day 1 and Day 8: Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Frequency tables will be presented by treatment group for all AEs and SAEs by System Organ Class (SOC) and Preferred Term (PT). Frequency tables will also be produced by treatment group for AEs leading to discontinuation from TP and study, by severity, and by causality. No formal statistical testing will be done
Measured: through Study Completion, an average of 720 Days
Laboratory safety assessments (hematology, serum chemistry, coagulation panel, urinalysis).
Frequency tables of each assessment abnormalities by grade and treatment will be presented. No formal statistical testing will be done.
Measured: through Study Completion, an average of 720 Days
Serum Cytokines (TNF-α, IL-4, IL-6, IL-10, IL-1β, MCP-1, MIP-1α, IFN-γ)
Frequency tables will be presented by treatment group. No formal statistical testing will be done
Measured: through CNP-Dosing Period, an average of 15 Days
Secondary outcomes (7)
To assess the change from baseline in Serum Alkaline Phosphatase (ALP) levels, for safety only
Change from baseline in ALP levels at Day 60 and Day 720
Measured: through Visit 6, an average of 60 Days and Visit 16, an average of 720 Days
To assess the change from baseline in AMA
Change from baseline in AMA between placebo and CNP-104 at Day 90 and Day 720
Measured: through Visit 7, an average of 90 Days and Visit 16, an average of 720 Days
To assess the change from baseline in liver fibrosis by FibroScan
Change from baseline in liver fibrosis by FibroScan between placebo and CNP-104 at Day 90 and Day 720
Measured: through Visit 7, an average of 90 Days and Visit 16, an average of 720 Days
To assess the change from baseline in modified PBC-40 score
Change from baseline in modified PBC-40 score between placebo and CNP-104 at Day 60 and Day 720
Measured: through Visit 6, an average of 60 Days and Visit 16, an average of 720 Days
To assess the change from baseline in Weekly Mean Itch Score
Change from baseline in Weekly Mean Itch Score between placebo and CNP-104 at Day 60 and Day 720
Measured: through Visit 6, an average of 60 Days and Visit 16, an average of 720 D
To assess the change from baseline in liver enzymes (Albumin, Bilirubin (total and direct), ALT, AST, GGT)
Change from baseline in liver enzymes at Days 60 and 720
Measured: through Visit 6, an average of 60 Days and Visit 16, an average of 720 Days
To assess the change in antigen specific CD4+ and CD8+ T cells
Change from baseline in antigen specific CD4+ and CD8+ T at Days 60 and 720
Measured: through Visit 6, an average of 60 Days and Visit 16, an average of 720 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start25 Jan 2022
- Primary completion30 Jan 2026
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Biliary CholangitisStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- COUR Pharmaceutical Development Company, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Bowlus, MD, Principal investigator, UC Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05104853
- Sponsor's protocol ID
- CNP-104-5.001
- Status last verified
- Mar 2026
- First submitted
- 22 Oct 2021
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Klatzkow H, Bhavsar-Burke I, Pearson M, Wentworth BJ. Primary Biliary Cholangitis in 2025: A New Frontier. Am J Gastroenterol. 2025 Dec 1;120(12):2746-2749. doi: 10.14309/ajg.0000000000003559. Epub 2025 May 29. No abstract available.
PubMed 40439725
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Double Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Efficacy of CNP-104 in Subjects Ages 18-75 With Primary Biliary Cholangitis Who Are Unresponsive to UDCA and/or OCA
- ClinicalTrials.gov ID
- NCT05104853
- Acronym / sponsor ID
- CNP-104-5.001
- Conditions
- Primary Biliary Cholangitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- COUR Pharmaceutical Development Company, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 3 Nov 2021 (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 study is a Phase 2a First-in-Human (FIH) clinical trial to assess the safety, tolerability, pharmacodynamics (PD), and efficacy of multiple ascending doses of CNP-104. The study consists of a 120 day primary study followed by a 20 month long-term safety and durability of response follow-up period.
Detailed description
Subjects ages 18-75 with primary biliary cholangitis will be screened up to 14 days prior to enrollment into the study. Screening will be completed to assess eligibility, obtain vital signs, collect laboratory samples and PD measurements, and to receive a FibroScan for liver fibrosis. Subjects will additionally complete an initial PBC-40 assessment and begin an Itch Diary, a questionnaire and scoring system to be completed by the patient every morning and evening through Day 120 and then monthly through end of study.
Subjects who meet all inclusion and no exclusion criteria after completing the screening visit will be enrolled in the study. Subjects will be randomized on Day 1 in a 1:1 ratio to receive either CNP-104 or Placebo (0.9% Sodium Chloride USP) by intravenous (IV) infusion. Subjects will be administered CNP-104 or Placebo on Day 1 and on Day 8. This study was originally designed with 2 cohorts, Cohort 1 comprised of 6 subjects randomized 1:1 to placebo or 4 mg/kg, and Cohort 2 comprised of up to 34 subjects randomized 1:1 to placebo or 8 mg/kg. Under Protocol Amendment 6 (v7.0), the remaining subjects for Cohort 2 (approximately 16) will be randomized 1:3:1 to placebo, 4 mg/kg, and 8 mg/kg respectively.
Subjects will remain in the clinic on Day 1 and Day 8 from the time of admission (prior to administration of CNP-104 or Placebo) through the final procedure conducted 4 hours post-dose that same day unless an infusion reaction, or other adverse event, requires an extended duration of monitoring. Subjects will be discharged if safety parameters are acceptable to the investigator.
Seven days after the second administration of CNP-104 or Placebo, subjects must return to the clinic for collection of safety labs, PD measurements, and assessment of AEs and medication changes.
Subjects will continue to be followed for 2 years to assess safety, pharmacodynamics, and immunogenicity during the Post-Dosing period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 4 mg/Kg CNP-104 | Experimental | Drug: CNP-104200 mL intravenous infusion on Day 1 and Day 8: 4 mg/Kg CNP-104 |
| 8 mg/Kg CNP-104 | Experimental | Drug: CNP-104200 mL intravenous infusion on Day 1 and Day 8: 8 mg/Kg CNP-104 |
| Placebo | Placebo comparator | Drug: Placebo200 mL intravenous infusion on Day 1 and Day 8: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Subjects who are willing and able to provide Institutional Review Board (IRB) approved written informed consent and privacy language as per national regulations.
- Men and non-pregnant women, ages 18-75 years inclusive.
- Subjects with a PBC diagnosis as demonstrated by the presence of 2 or more of the following 3 diagnostic factors:
- Subjects who are unresponsive to UDCA and/or OCA after 6 months of treatment at a stable dose as measured by ALP > 1.5× ULN.
- For subjects on any medication used to treat the symptoms of PBC (ex. UDCA, OCA, seladelpar), subjects must be on a stable dose for a minimum of 3 months prior to enrollment and must agree not to change their dose through study Day 60 unless reviewed by the medical monitor and approved by the site investigator.
Key exclusion criteria (35 listed)
- Subjects with a Class B or Class C Child-Pugh score.
- Subjects with concomitant liver diseases including chronic viral hepatitis B or C, autoimmune hepatitis, PSC, alcoholic liver disease, Wilson's disease, hemochromatosis, or Gilbert's syndrome.
- Subjects who have previously undergone liver transplantation.
- Subjects with decompensated liver disease as defined by the presence or history of any of the following:
- Subjects with a history of cerebrovascular accident in the past 12 months.
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 |
|---|---|---|
| CNP-104CNP-104 is comprised of PDC-E2 peptide dispersed within a negatively charged polymer matrix of poly (lactic-co-glycolic acid) (PLGA) particles at a target concentration of ~1 μg of PDC-E2 peptide per mg of PLGA particles. | Drug | 4 mg/Kg CNP-104, 8 mg/Kg CNP-104 |
| PlaceboCNP-104 Placebo | Drug | Placebo |
Primary outcome
Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: through Study Completion, an average of 720 Days
Frequency tables will be presented by treatment group for all AEs and SAEs by System Organ Class (SOC) and Preferred Term (PT). Frequency tables will also be produced by treatment group for AEs leading to discontinuation from TP and study, by severity, and by causality. No formal statistical testing will be done
Laboratory safety assessments (hematology, serum chemistry, coagulation panel, urinalysis).
Time frame: through Study Completion, an average of 720 Days
Frequency tables of each assessment abnormalities by grade and treatment will be presented. No formal statistical testing will be done.
Serum Cytokines (TNF-α, IL-4, IL-6, IL-10, IL-1β, MCP-1, MIP-1α, IFN-γ)
Time frame: through CNP-Dosing Period, an average of 15 Days
Frequency tables will be presented by treatment group. No formal statistical testing will be done
7 secondary outcomes
To assess the change from baseline in Serum Alkaline Phosphatase (ALP) levels, for safety only
Time frame: through Visit 6, an average of 60 Days and Visit 16, an average of 720 Days
To assess the change from baseline in AMA
Time frame: through Visit 7, an average of 90 Days and Visit 16, an average of 720 Days
To assess the change from baseline in liver fibrosis by FibroScan
Time frame: through Visit 7, an average of 90 Days and Visit 16, an average of 720 Days
To assess the change from baseline in modified PBC-40 score
Time frame: through Visit 6, an average of 60 Days and Visit 16, an average of 720 Days
To assess the change from baseline in Weekly Mean Itch Score
Time frame: through Visit 6, an average of 60 Days and Visit 16, an average of 720 D
To assess the change from baseline in liver enzymes (Albumin, Bilirubin (total and direct), ALT, AST, GGT)
Time frame: through Visit 6, an average of 60 Days and Visit 16, an average of 720 Days
To assess the change in antigen specific CD4+ and CD8+ T cells
Time frame: through Visit 6, an average of 60 Days and Visit 16, an average of 720 Days
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 10 Mar 2026.
- Derived from this study: PubMed 40439725Klatzkow H, Bhavsar-Burke I, Pearson M, Wentworth BJ. Primary Biliary Cholangitis in 2025: A New Frontier. Am J Gastroenterol. 2025 Dec 1;120(12):2746-2749. doi: 10.14309/ajg.0000000000003559. Epub 2025 May 29. No abstract available.
- 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.
Christopher Bowlus, MD principal investigator
UC Davis
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CNP-104 in people with Primary Biliary Cholangitis, run by COUR Pharmaceutical Development Company, Inc. at 19 sites 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 15 inclusion and 35 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 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: through Study Completion, an average of 720 Days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05104853, which also lists 1 linked publication.
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 10 Mar 2026.