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NCT07905157Not yet recruitingPhase 1

A Study to Compare Blood Levels of Bepirovirsen and Safety Using Different Methods of Injecting in Healthy Adult Participants

A Phase 1, Randomized, Open-Label, Parallel-Group, Single-Dose Study to Compare the Pharmacokinetics and Safety of Bepirovirsen When Delivered From a Vial or a 1ml Autoinjector in Healthy Adult Participants

Source: ClinicalTrials.gov · Last updated 29 Oct 2026

Brief summary (registry, in English)

This is an open-label study being done to compare two different methods of study medicine bepirovirsen is given in healthy adults. The researchers want to learn how the body affects the medicine over time (pharmacokinetic \[PK\] study). The study will also evaluate the safety of bepirovirsen and how well it is tolerated, meaning how people feel after receiving the medicine and whether they experience any side effects.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
98 (estimated)
First submitted
23 Oct 2026
Start date
3 Nov 2026
Primary completion date
30 Mar 2027
Lead sponsor
GlaxoSmithKline
Diseases
Hepatitis B
NCT number
NCT07905157

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 98
  • From 3 Nov 2026 to the primary completion date, 30 Mar 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Past, current or intended use of over-the-counter or prescription medication including herbal medications within 7 days or 5 half-lives (whichever is longer) before dosing.
  • Prior use of immunosuppressive drugs within 3 months before dosing or interferon within 12 months before dosing.
  • Prior treatment with any oligonucleotide or small interfering ribonucleic acid (siRNA) within 12 months before dosing
  • Participants for whom immunosuppressive treatment, including therapeutic doses of steroids, is contraindicated.
  • Prior treatment with bepirovirsen.
    • Prior/Concurrent clinical study participation:
  • Exposure to more than 4 new drugs within 12 months prior to the first dosing day.
  • The participant has participated in a clinical trial and has received an investigational product within the following time period prior to dosing in the current study: 5 half-lives (if known) or twice the duration (if known) of the biological effect of the study intervention (whichever is longer) or 90 days (if half-life or duration is unknown), or, current participation in another clinical study
  • Positive pre-study drug/alcohol screen, including tetrahydrocannabinol (THC).
  • Presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to first dose of study intervention.
  • Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention.
    • Note: Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative hepatitis C RNA test is obtained.
    • \- Positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study intervention.
    • Note: Test is optional and participants with negative hepatitis C antibody test are not required to also undergo hepatitis C RNA testing.
    • Cardiac Safety:
  • Regular alcohol consumption within 6 months prior to the study defined as an average weekly intake of \>14 units for males or females. One unit is equivalent to 8 g of alcohol: a half-pint (\~240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
    • Others:
  • Regular use of known drugs of abuse, including tetrahydrocannabinol (THC).

Other illness

  • History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.
  • Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
  • Participants with any other medical conditions which, in the judgement of the investigator (or in consultation with the Medical Monitor), could jeopardize the integrity of the safety of the participant or the data derived from that participant.
  • Current or chronic history of liver disease, hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • Cotinine levels indicative of regular or recent use of tobacco products or nicotine-containing products, including cigarettes, cigars, pipes and materials used to 'vape 'Positive Human Immunodeficiency Virus (HIV) antibody test.
    • Liver safety:
  • Sensitivity or history of sensitivity to the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator \[or medical monitor\] contraindicates participation in the clinical study.
  • Use of any products intended to treat medical conditions that are not approved by the governing health authority in a given country or region (for example, herbal medicine, health supplements, traditional medicine, homeopathic remedies, etc.).

Lab values

  • Participants requiring anti-coagulation therapies (e.g., warfarin, Factor Xa inhibitors) or anti-platelet agents (including but not limited to clopidogrel or aspirin) unless treatment can safely be discontinued throughout duration of study intervention, by the discretion of the investigator. Occasional use is permitted.
  • Alanine transaminase (ALT) \>1.5 × upper limit of normal (ULN).
  • Total bilirubin \>1.5 × ULN (isolated total bilirubin \>1.5 × ULN is acceptable if total bilirubin is fractionated and direct bilirubin \< 35 percent (%). Participants with Gilbert's syndrome can be included with total bilirubin \>1.5xULN if direct bilirubin is \<= 1.5xULN.
  • For participants with benign unconjugated hyperbilirubinemia with total bilirubin \>1.25 × ULN, the investigator should review the results in conjunction with other medical history to confirm eligibility.
  • Serum albumin \<=3.5 gram per deciliter (g/dL).
  • Corrected QT interval (QTc) QTcF \>= 450 milliseconds (msec) (mean of triplicate measurements should be used at screening to confirm that participant meets exclusion criterion
  • Platelets \<140x10\^9/L.

Other

  • Abnormal blood pressure, as determined by the investigator.
  • Loss of blood or blood products in excess of 500 milliliters (mL) within any 3-month period during the study.
  • Enrollment into another clinical study whilst participating in this study.
    • Diagnostic assessments:
  • Sensitivity to heparin or heparin-induced thrombocytopenia.

Who the study is looking for

  • Age greater than or equal to (\>=) 18 and less than or equal to (\<=) 65 years at the time of signing the informed consent.
  • Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, electrocardiogram (ECGs) and vital signs.
  • Body weight \>=50 kilograms (kg) and body mass index (BMI) \>= 19.0 to 29.9 kilograms per square meter (kg/m\^2).
  • Male and female participants, as follows:
    • Male Participants: There are no contraceptive requirements for male participants.
    • A female participant is eligible to participate if they are not pregnant or breastfeeding, and one of the following conditions applies:
    • Is a participant of non-childbearing potential (PONCBP), or
    • Is a participant of childbearing potential (POCBP) and using an acceptable contraceptive method 28 days prior to and during the study intervention period and for at least 16 weeks after the last dose of study intervention. The Investigator should evaluate the potential for contraceptive method failure (for example, non-compliance, recently initiated in relationship to the first dose of study intervention).
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.

Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.