AzTrials
AzTrials

Chronic Hepatitis B Virus InfectionPhase 1NCT07389044

A Study on IB-001 Dose Response and Tolerability in Healthy Adults and Those With Chronic Hepatitis B

A Phase 1 study testing IB-001 and Peginterferon Alfa-2A in people with Chronic Hepatitis B Virus Infection, run by IntegerBio at 5 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study will examine the safety and tolerability of single and multiple doses of IB-001 in two parts: Part A: SAD study in approximately 50 Healthy Volunteers (HV). Part B: MAD study in approximately 30 adult participants living with Chronic Hepatitis B (CHB). Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Chronic Hepatitis B Virus Infection
What is being tested?
IB-001 and Peginterferon Alfa-2A
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
88 participants
Where
5 sitesin 4 countries
Study dates
20 Feb 2026to 1 Jul 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

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 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Able and willing to provide written informed consent.
  • Male or female aged 18 to 70 years.
  • Females must not be of childbearing potential OR those who are of childbearing potential must be non-pregnant and non-lactating and willing to use a highly effective method of contraception. Males whose partners are of childbearing potential must either be surgically sterile or willing to use a highly effective acceptable method of contraception.
  • Non-tattooed, clear injection site suitable for SC injection and monitoring in the opinion of the Investigator.
  • Able and willing to provide written informed consent.
  • Male or female aged 18 to 70 years,
Show all 11Show fewer
  • BMI between 18 and 35 kg/m2.
  • Females must not be of childbearing potential OR those who are of childbearing potential must be non-pregnant and non-lactating and willing to use a highly effective method of contraception. Males whose partners are of childbearing potential must either be surgically sterile or willing to use a highly effective acceptable method of contraception.
  • Diagnosed with CHB and are HBeAg-negative (on 2 occasions at least 6 months apart) and have HBsAg titers of ≥ 100 IU/mL at Screening.
  • Participants must be treatment naive (i.e., have never received treatment with HBV antiviral medicines [NUCs, IFN] or an investigational anti-HBV agent) or currently not treated (i.e., not been on treatment with approved [NUCs, IFN] or investigational anti-HBV medicines within 12 months prior to randomization).
  • Vital signs and physical examination are normal, or abnormal values are not clinically significant in the opinion of the Investigator.

Who cannot join

  • Healthy Volunteer participants must not meet any of the following criteria at Screening or upon admission to the site (on Day -1).
  • Major surgery requiring general anesthesia within 12 weeks prior to Screening or is expected to have surgery requiring general anesthesia during the course of the study.
  • History of severe allergic or anaphylactic reactions, or sensitivity to the IP or its constituents.
  • Blood donation or blood loss of ≥ 1 unit (450 mL) of whole blood within 4 weeks before Screening or plasma donations within 7 days prior to dosing of investigational product (IP).
  • Any underlying medical condition (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrinological, tumor, pulmonary, immune, mental, or cardiovascular and cerebrovascular diseases).
  • History of malignancy, except for non-melanoma skin cancer, excised more than 1 year prior to Screening or cervical intraepithelial neoplasia that has been successfully cured more than 5 years prior to Screening.
Show all 54Show fewer
  • Current hepatitis A virus (HAV) infection, hepatitis B virus (HBV) infection, hepatitis C virus (HCV) infection.
  • Positive test for HIV-1 or HIV-2 antibodies.
  • Any other active infection requiring systemic antiviral or antimicrobial therapy that will not be completed within 2 weeks of first dosing.
  • Clinically significant abnormalities on Screening ECG or history of cardiac arrhythmias, risk factors for Torsade de Pointes (hypokalemia, hypomagnesemia, decompensated heart failure and acute myocardial infarction), and a QTcF > 450 ms (males) or QTcF > 470 ms (females) at Screening.
  • Physical examination findings at Screening that are considered clinically significant by the Investigator and likely to adversely impact study conduct and/or interpretation.
  • Clinically significant abnormal vital signs
  • Laboratory abnormalities considered clinically significant by the Investigator at Screening. From Cohort A3 onwards, participants with blood platelet counts < 150 × 109/L or absolute neutrophil counts < 1.5 × 109/L will be excluded.
  • Receipt of any investigational drug or product within 90 days of Study Day 1 or within 5 times the elimination half-life of the medication prior to first dosing with the IP, whichever is earlier. Receipt of an invasive medical device within 90 days before first dosing with the IP that in the opinion of the PI or designee may impact the ability of the participant to complete all protocol-required procedures. Participants must not have participated in interventional clinical studies more than 4 times per year.
  • Use of any prescribed or over-the-counter medications (including vitamins or herbal remedies) within 2 weeks of first dosing or within 5 times the elimination half-life of the medication prior to first dosing.
  • Has received live vaccine(s) within 28 days of Screening or plans to receive live vaccines within 28 days of dosing with the IP on Study Day 1. Note: COVID-19 vaccines are not considered live vaccines.
  • Any suspicion or history of drug and/or alcohol abuse within the last year.
  • Positive toxicology Screening panel (urine test including qualitative identification of tetrahydrocannabinol, cocaine, amphetamines, benzodiazepines, opiates, methadone, methamphetamines, ecstasy, and phencyclidine).
  • Positive alcohol breath test at Screening and/or on Study Day -1.
  • History (within 90 days of Screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams of alcohol). Alcohol consumption will be prohibited at least 48 hours before dosing with the IP on Study Day 1, and during the in-house stay at the clinical research unit.
  • Uses more than 5 cigarettes, or equivalent, per day in the 3 months prior to Screening, and/or is unwilling to abstain from nicotine-containing products for 48 hours prior to admission to the site and during the in-house stay at the clinical research unit.
  • Pregnant or planning to become pregnant during the course of the study, or currently breastfeeding.
  • Any other factor that makes it inappropriate for study participation per the Investigator's judgment.
  • For Part C Only:
  • Clinically significant retinal disease; severe, uncontrolled, or unstable psychiatric illness, including major depression; uncontrolled thyroid disease or clinically significant abnormalities in thyroid stimulating hormone (TSH) or free T4, per Investigator's judgment.
  • Known hypersensitivity to peginterferon alfa-2a, interferons, PEG, or any component of the IP formulation.
  • Any other contraindications listed in the peginterferon alfa-2a product Data Sheet per Investigator's judgment
  • PART B: Participants with Chronic Hepatitis B (CHB)
  • Evidence or history of liver disease of non-HBV etiology, including but not limited to HAV, HCV, HDV, or HEV (endemic regions only) infections; drug- or alcohol-related liver disease; autoimmune hepatitis; hemochromatosis; Wilson's disease; α-1 antitrypsin deficiency; primary biliary cirrhosis; primary sclerosing cholangitis; non-alcoholic steatohepatitis; or any other non-HBV liver disease considered clinically significant by the Investigator. Participants with metabolic dysfunction-associated steatotic liver disease without any signs of steatohepatitis or those with documented Gilbert's Syndrome, are eligible.
  • Diagnosed or suspected hepatocellular carcinoma (HCC).
  • Significant liver fibrosis or cirrhosis (FibroScan result > 8.5 kPa within 12 months of Screening; Prior liver biopsy with Metavir F3 fibrosis or F4 cirrhosis within 2 years of Screening; AST-to-Platelet Index (APRI) > 1 and FibroTest result > 0.5 within 12 months of Screening).
  • Positive for HIV-1 or HIV-2 at Screening.
  • Active infection requiring systemic antiviral or antimicrobial therapy that will not be completed within 2 weeks of first dosing of investigational product (IP).
  • Any of the following clinical laboratory values at Screening: ALT or AST ≥ 3 × ULN; blood platelet counts < 120 × 109/L; absolute neutrophil count < 1.3 × 109/L; hemoglobin < 10.0 g/dL; serum total bilirubin ≥ 1 × ULN (Note: for participants with documented Gilbert's Syndrome, total bilirubin ≥ 2 × ULN is acceptable); serum albumin < 35 g/L; eGFR of < 60 mL/min/1.73 m2; INR > 1.2 × ULN.
  • History of severe allergic or anaphylactic reactions, or sensitivity to the IP or constituents.
  • Blood donation or blood loss of ≥ 1 unit (450 mL) of whole blood within 4 weeks before Screening or plasma donations within 7 days prior to first dosing with the IP.
  • History or presence of immune-mediated disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune hepatitis, sarcoidosis, psoriasis of greater than mild severity, autoimmune uveitis), or cerebrovascular, chronic pulmonary or cardiac disease associated with functional limitation, retinopathy, uncontrolled thyroid disease (thyroid stimulating hormone [TSH] > 10 or < 0.4 mU/L), or uncontrolled seizure disorder, as determined by the Investigator. Participants who are positive for anti-thyroglobulin antibodies or anti-thyroid peroxidase antibodies will be excluded.
  • History or presence of significant (as judged by the Investigator) cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological disorders, or diagnosed central or peripheral neurological disease, capable of significantly altering the absorption, metabolism, or elimination of drugs, of constituting a safety-related risk when taking the study treatment, requiring premedication, or of interfering with the interpretation of the data.
  • Clinically significant 12-lead ECG abnormalities on Screening ECG or history of cardiac arrhythmias, risk factors for Torsade de Pointes (hypokalemia, hypomagnesemia, decompensated heart failure and acute myocardial infarction), and cardiac arrhythmias, risk factors for Torsade de Pointes (hypokalemia, hypomagnesemia, decompensated heart failure and acute myocardial infarction), and QTcF > 450 ms for males or QTcF > 470 ms for females at Screening.
  • Physical examination findings that are considered clinically significant by the Investigator and likely to adversely impact study conduct and/or interpretation.
  • Clinically significant abnormal vital signs, confirmed with retesting after at least 5 minutes of additional rest.
  • History (within 90 days of Screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams of alcohol).
  • Positive alcohol breath test at Screening and/or on Study Day 1. Alcohol consumption will be prohibited at least 48 hours before each dose with the IP, and during any in-house stays in the clinical research unit or investigational site (if applicable).
  • Use of more than 5 cigarettes per day or equivalent (e.g., cigarettes, vapes, nicotine patches, cigars, chewing tobacco) in the 3 months prior to Screening. Nicotine-containing products (eg, cigars, cigarettes, vapes) will be prohibited at least 48 hours before each dose with the IP, and during any in-house stays in the clinical research unit or investigational site (if applicable).
  • Participants must not have participated in interventional clinical studies more than 4 times per year. Receipt of any investigational drug or product within 90-days of Study Day 1 or within 5 times the elimination half-life of the medication prior to first dosing with the IP, whichever is earlier. Receipt of a device within 90 days before first dosing with the IP that in the opinion of the Investigator may impact the ability of the participant to complete all protocol-required procedures or testing.
  • Received solid organ or bone marrow transplant.
  • Any immunosuppressing, immunomodulator (e.g., thymosin) or cytotoxic drug administrations within 6 months before first dosing with the IP (Day 1).
  • Received any antiplatelet (e.g., aspirin, clopidogrel) or antithrombotic therapy (e.g., warfarin, dabigatran, apixaban) within 14 days prior to first dosing with the IP and throughout the study.
  • Has received live vaccine(s) within 28 days of Screening or plans to receive live vaccines within 28 days of dosing with the IP. Note: COVID-19 vaccines are not considered live vaccines.
  • Use of corticosteroids above 5 mg/day of prednisone (or equivalent) or other immunosuppressive medications within 4 weeks prior to Screening. Note: topical, intra-articular and inhaled steroids allowed.
  • Use of any herbal medicines or supplements within 3 months prior to Screening visit that are known to be hepatotoxic based on Investigator's opinion or who have initiated any new herbal medicine or supplement within 30 days prior to Study Day 1. Eligibility to participate should be discussed with the Sponsor's medical representative.
  • Pregnant (positive serum pregnancy test at Screening or a positive urine pregnancy test predose on Study Day 1), planning to become pregnant during the course of the study, or currently breastfeeding.
  • Any other factor that makes it inappropriate for study participation per the Investigator's judgment.
  • Other prohibited medications during the study: Treatments that may increase ALT or AST (eg, augmentin, > 2 g paracetamol/day, initiating treatment with an HMG-CoA [3-hydroxy-3-methylglutaryl coenzyme A] reductase inhibitor [statins]) should be avoided. The use of these drugs, if necessary, should be discussed with the PI or Sponsor's medical representative or designee, preferably before initiation of their administration. Simple analgesia (paracetamol < 2 g/day, NSAID at therapeutic doses) may be prescribed as premedication prior to dosing of IP, if recommended by the SRC.

Trial locations and contacts

5 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Carey Hwang, MD, PhD contact

+1 615 491 2553

ClinOps@integer.bio

Nick Hourguettes contact

+1 240 656 2820

ClinOps@integer.bio

5 sites in 4 countries

Hong Kong2 sites, 2 recruiting

  • Prince of Wales Hospital

    Hong Kong, 999077

    Grace Lai-hung Wong

    Recruiting

  • Queen Mary Hospital

    Hong Kong, 999077

    Man-Fung Yuen

    Recruiting

Other trials in Hong Kong

Moldova1 site, 1 recruiting

  • Arensia Exploratory Medicine Chisinau

    Chisinau, 2025

    Alina Juvoc

    Recruiting

Other trials in Moldova

New Zealand1 site, 1 recruiting

  • New Zealand Clinical Research

    Auckland, Auckland, 1010

    Edward Gane, MBChB, MD, +64 021548371 ext. 22922, EdGane@adhb.govt.nz

    Edward Gane, MBChB, MD

    Recruiting

Other trials in New Zealand

Ukraine1 site, 1 recruiting

  • Arensia Exploratory Medicine

    Kyiv, 2000

    Marta Dobryanska

    Recruiting

Other trials in Ukraine

About this study

Official title: A Phase 1, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics, And Preliminary Efficacy of Single and Multiple Ascending Doses of IB-001 in Healthy Participants and Participants With Chronic Hepatitis B

This study will examine the safety and tolerability of single and multiple doses of IB-001 in two parts:

Part A: SAD study in approximately 50 Healthy Volunteers (HV). Part B: MAD study in approximately 30 adult participants living with Chronic Hepatitis B (CHB).

A separate exploratory, open-label, single-dose cohort (Part C) will evaluate pegylated interferon alfa-2a in HVs for translational benchmarking against IB-001.

Read the detailed description

This is a first-in-human, double-blind, randomized, placebo-controlled Phase 1 study of IB-001 administered subcutaneously to evaluate safety, tolerability, PK/PD, and preliminary antiviral activity.

The study is comprised of three parts:

Part A: Single-dose, multicohort, dose-finding study in approximately 50 adult Healthy Volunteers (HV) in up to five cohorts (n=10 per cohort; 8 active:2 placebo). Participants will receive a single sub-cutaneous dose of investigational product followed by a 28-day post treatment follow-up.

Part B: Multidose, multicohort study in Treatment-Naïve or Currently-Not-Treated Adults with Chronic Hepatitis B (CHB).

Approximately 30 adult participants (up to 3 cohorts; n=10 per cohort; 8 active:2 placebo). Once-weekly sub-cutaneous dosing over 4 weeks with 6-week post-treatment follow-up. Dose recommendations in both Part A and Part B will be made by the Safety Review Committee (SRC) based on review of emerging safety data.

Part C: Single-dose, open label, single cohort study in approximately 8 adult Healthy Volunteers (HV). Participants will receive a single sub-cutaneous dose of peginterferon alfa-2a followed by a 14 day post treatment follow-up.

Being tested
IB-001, Placebo, Peginterferon Alfa-2A
Keywords
First in Human, Hepatitis B virus, HBV, Chronic Hepatitis B, Dose finding, Dose Ranging
Medical subject headings
Hepatitis B, Chronic, Hepatitis B

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IB-001Drug

    IB-001 is an investigational product targeting the type I IFN (IFN-I) signaling pathway. Subcutaneous (SC) injectable formulation; single doses in HVs (Part A) and weekly doses for 4 weeks in CHB participants (Part B). Exact dose levels recommended by SRC.

  • PlaceboOther

    Sodium Chloride (NaCl) 0.9 % administered subcutaneously as a single dose (Part A) and weekly dose for 4 weeks (Part B).

  • Peginterferon Alfa-2ADrug

    Peginterferon alfa-2a administered subcutaneously as a single dose (Part C) at a dose of 180 mcg/0.5 mL solution.

Study groups in NCT07389044
Study groupRoleWhat they receive
Arm 1: IB-001ExperimentalParticipants receive IB-001, administered subcutaneously according to the assigned cohort schedule. In Part A, participants receive a single dose. In Part B, participants receive once-weekly dosing for 4 weeks.
Receives: Drug: IB-001
Arm 2: PlaceboPlacebo comparatorParticipants receiving placebo, follow the same dosing schedule as the active arm (single dose in Part A; once-weekly for 4 weeks in Part B).
Receives: Other: Placebo
Arm 3: Peginterferon alfa-2aExperimentalParticipants in Part C receive a single dose of peginterferon alfa-2a, administered subcutaneously
Receives: Drug: Peginterferon Alfa-2A

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A and Part B: Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs).

    Treatment-Emergent Adverse Events (TEAEs) are adverse events that first appear or worsen in severity during the course of the clinical study, regardless of whether they are related to the investigational product (IP) or not. TEAEs will be coded using MedDRA and summarized by SOC, PT, severity, and relationship to IP. Treatment-related AEs (possibly/probably/definitely related) will also be summarized separately. A by-participant AE listing will be provided

    Measured: Through Day 29 (Part A), through Day 64 (Part B).

  2. Part A and Part B: Number of Participants with Adverse Events (AEs) by Severity

    An AE is any unfavorable medical occurrence in a study participant administered an investigational product. The AE does not necessarily have a causal relationship with the treatment. All AEs will be graded for severity according to NCI-CTCAE classification. If an appropriate AE term is not found in NCI-CTCAE, the AE will be graded as follows: Grade 1 (mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (Severe) and Grade 5 (Death).

    Measured: Through Day 29 (Part A), through Day 64 (Part B)

  3. Part A and Part B: Number of Participants with Adverse Events (AEs) of Special Interest (AESIs)

    AEs of special interest include Cytokine Release Syndrome (CRS), Injection Site Reactions (ISRs) and Unexplained Liver Biochemistry Elevations. Reported AESIs will be graded according to NCI-CTCAE classification. If an appropriate AE term is not found in NCI-CTCAE, the AESI will be graded as follows: Grade 1 (mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (Severe) and Grade 5 (Death).

    Measured: Through Day 29 (Part A), through Day 64 (Part B)

  4. Part A and Part B: Number of Participants with Clinically Significant Changes in Laboratory Parameters

    Assessment Method - Number of participants with clinical laboratory abnormalities (serum chemistry, hematology, and coagulation) will be reported.

    Measured: Through Day 15 (Part A), through Day 64 (Part B)

  5. Part A and Part B: Number of Participants with Clinically Significant Changes in Vital Signs.

    Number of participants with vital signs abnormalities will be reported. Vital signs include body temperature, pulse rate, respiratory rate, and blood pressure.

    Measured: Through Day 15 (Part A), through Day 64 (Part B)

  6. Part A and Part B: Number of Patients with Clinically Significant Changes in Cardiac Parameters.

    Number of participants with electrocardiogram (ECG) abnormalities will be reported.

    Measured: Through Day 15 (Part A), through Day 64 (Part B)

Secondary outcomes (8)

  1. Part A and Part B: Number of Patients with Clinically Significant Anti-Drug Antibodies (ADAs).

    All immunogenicity data (ADA) are to be analyzed using the Immunogenicity Analysis Population. ADA incidence and titer levels over time will be summarized by dose.

    Measured: Through Day 29 (Part A), through Day 64 (Part B)

  2. Part B: Changes from Baseline in HBsAg levels over time.

    Blood samples will be analyzed for HBsAg levels to establish baseline and determine eligibility; subsequent blood samples will be collected at protocol-specified timepoints to measure HBsAg changes over time.

    Measured: Through Day 64 (Part B)

  3. Part B: Change from Baseline in Anti-HBs Antibody Titers over time.

    Blood samples will be collected at baseline and at protocol-specified timepoints to measure anti-HBs antibody titer changes over time.

    Measured: Through Day 64

  4. Part B: Reduction from Baseline in HBV DNA levels over time.

    Blood samples will be collected at baseline and at protocol-specified timepoints to measure HBV DNA changes over time.

    Measured: Through Day 64

  5. Part A and Part B: PK Parameter - Maximum Observed Serum Concentration (Cmax) of IB-001

    The Cmax is the maximum observed concentration of IB-001 in serum following single or multiple ascending dose administration. Blood samples will be collected at baseline and at protocol-specified timepoints.

    Measured: Through Day 29 (Part A), through Day 64 (Part B)

  6. Part A and Part B: PK Parameter - Area under the Serum Concentration Time Curve (AUC) of IB-001.

    AUC is the area under the concentration time curve of IB-001 in serum following single or multiple ascending dose administration. Blood samples will be collected at baseline and at protocol-specified timepoints.

    Measured: Through Day 29 (Part A), through Day 64 (Part B)

  7. Part A and Part B: PK Parameter - Time to Observed Maximum Serum Concentration (Tmax) of IB-001.

    Tmax is the time it takes to reach maximum concentration of IB-001 in serum following single or multiple ascending dose administration. Blood samples will be collected at baseline and at protocol-specified timepoints.

    Measured: Through Day 29 (Part A), through Day 64 (Part B)

  8. Part A and Part B: PK Parameter - Terminal Half Life (T1/2) of IB-001.

    T1/2 will be measured following single and multiple doses of IB-001. Blood samples will be collected at baseline and at protocol-specified timepoints.

    Measured: Through Day 29 (Part A), through Day 64 (Part B)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2026
  2. Study start20 Feb 2026
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion1 Jul 2027 (estimated)

Resources

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
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07389044
Sponsor's protocol ID
IB001-001
Status last verified
Sep 2026
First submitted
16 Jan 2026
Last updated
28 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IB-001 and Peginterferon Alfa-2A in people with Chronic Hepatitis B Virus Infection, run by IntegerBio at 5 sites in 4 countries.

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 11 inclusion and 54 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: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Hong Kong, Moldova, New Zealand, Ukraine. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Carey Hwang, MD, PhD (+1 615 491 2553, ClinOps@integer.bio), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A and Part B: Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs). (time frame: Through Day 29 (Part A), through Day 64 (Part B).). The study lists 6 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 NCT07389044.

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 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in