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Safety, Tolerability and Pharmacokinetics of Zosurabalpin After Multiple Intravenous Doses in Healthy Participants

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study does not focus on a disease; instead, it evaluates the safety and how the body handles a new medicine called zosurabalpin. The drug is given by intravenous infusion, which means it is delivered directly into a vein, using a small tube called a peripherally inserted central venous catheter (PICC) line. The purpose of the study is to assess the safety, tolerability, and pharmacokinetics of the medication in healthy volunteers.

Participants will receive several doses of the medicine through the IV line over a short period while staying at the clinic for close observation. During the stay, doctors will watch for any adverse events (unwanted side effects) and will regularly check vital signs such as blood pressure, heart rate, and temperature, as well as perform an ECG (a test that records the heart’s electrical activity). Blood and urine samples will be taken to measure the amount of drug in the body, helping to understand how the medication is processed. After the dosing period, participants will have follow‑up visits to ensure any changes have returned to normal.

The research process

The trial runs in 10 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and Consent

    You will read and sign an informed consent form that explains the purpose of the study and what will be required of you.

    After signing, you become a participant in the trial.

  2. Step 2

    Baseline Health Assessments

    A series of measurements will be taken to confirm that you are healthy, including vital signs such as blood pressure and heart rate.

    A physical examination, an electrocardiogram (ECG) to check heart rhythm, and laboratory tests on blood and urine will be performed.

  3. Step 3

    Insertion of PICC Line

    A peripherally inserted central catheter (PICC line) will be placed in a vein of your arm to allow repeated intravenous (IV) infusions.

    The procedure is done by a qualified healthcare professional and you will be monitored for any immediate reactions.

  4. Step 4

    First IV Dose of Zosurabalpin

    You will receive the first dose of zosurabalpin through the PICC line as an IV infusion.

    The exact dose and infusion time will follow the study protocol.

  5. Step 5

    Immediate Post‑Infusion Monitoring

    After the infusion you will stay in the clinic while vital signs are checked regularly.

    Staff will observe you for any adverse events such as dizziness, headache, or changes in heart rhythm.

  6. Step 6

    Pharmacokinetic Sample Collection

    Blood and urine samples will be taken at scheduled times to measure the amount of zosurabalpin and its metabolites in your body.

    These measurements are part of the study of pharmacokinetics (how the drug is absorbed, distributed, metabolized, and excreted).

  7. Step 7

    Additional IV Doses

    You will receive further IV infusions of zosurabalpin on the days defined by the study schedule.

    Each dose will be administered through the same PICC line.

  8. Step 8

    Ongoing Safety Monitoring and Sampling

    After each infusion you will be monitored for vital signs and any new adverse events.

    Additional blood and urine collections will be performed to continue the assessment of pharmacokinetics.

  9. Step 9

    Final Study Assessments

    When the last dose has been given, a final set of vital sign measurements, ECG, and laboratory tests will be performed.

    The study team will review all recorded adverse events and overall safety information.

  10. Step 10

    Follow‑Up Visit

    You will attend a follow‑up visit after the study to confirm that you have returned to your normal health status.

    Any remaining data, such as late‑occurring laboratory results, will be collected at this visit.

Who can join the trial?

6 criteria

  • Be able and willing to sign a written informed consent form and follow all study instructions.
  • Be between 18 and 64 years old (inclusive) at the time of screening.
  • Both men and women are allowed to take part in the study.
  • Follow the study’s contraception and abstinence requirements (use birth‑control methods or avoid sexual activity as instructed).
  • Be a healthy volunteer, meaning no active or chronic illnesses, confirmed by a detailed medical history, physical exam, vital signs, a 12‑lead electrocardiogram (ECG) (a heart‑rhythm test), blood tests for hematology (blood‑cell counts), blood chemistry (chemicals in the blood), serology (antibody testing), coagulation (blood‑clotting), and a urine test (urinalysis).
  • Weigh at least 50 kg and have a body mass index (BMI) between 18 and 32 kg/m² (a measure of weight relative to height).

Who cannot join the trial?

5 criteria

  • Having a history of malignancy (cancer) or any serious disease that affects the stomach or intestines (gastrointestinal), kidneys (renal), liver (hepatic), lungs (bronchopulmonary), nerves (neurological), mind (psychiatric), heart (cardiovascular), hormones (endocrinological), blood (hematological), allergies (allergic disease), metabolism (metabolic disorder), or causes liver scarring (cirrhosis).
  • Having any medical condition that could change how the body handles medicines—specifically the processes of absorption, distribution, metabolism, or elimination—or having had surgery on the digestive tract that affects stomach movement, except for simple appendix removal or hernia repair.
  • Using any prescription drugs, herbal products, over‑the‑counter medicines, vitamins, or dietary supplements within 14 days before the study (or longer if the drug stays in the body for a longer time), and having taken steroids (glucocorticoids) or other immune‑suppressing medicines (immunosuppressive) within 30 days (or longer if they remain in the body longer).
  • Testing positive for HIV infection, hepatitis B surface antigen, or hepatitis C antibody.
  • Having a significant history of severe allergy or allergic reaction (hypersensitivity) to foods, environmental substances, or medicines, including reactions that might occur with the study drug.
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Investigated drugs

Zosurabalpin is an investigational medicine being tested to see how safe it is and how well it is tolerated when given directly into a vein. In this study participants receive several doses through a small tube (a peripherally inserted central venous catheter, or PICC line) that sits in a large vein. Researchers will monitor participants for any side effects and will also measure how the drug and its breakdown products move through the body. This information helps determine whether the medicine can be used safely in future studies.

What is already known about the treatment

Zosurabalpin - Zosurabalpin is given by intravenous infusion through a peripherally inserted central venous catheter (PICC line), meaning it is delivered directly into a vein using a small tube. It is an experimental medication that is still in early clinical testing and has not yet been approved for any medical use. The drug is being studied for its potential to protect nerve cells and reduce damage after injury, although no specific disease is being targeted in this safety study. Zosurabalpin works by attaching to a protein called BCL‑2, which helps cells avoid programmed death, and it belongs to the class of BCL‑2 inhibitors.
Trial detailsLast updated 10 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-505411-20-00Protocol codeBP44773Estimated enrolment30 patientsSponsorF. Hoffmann-La Roche AG

sourced from the EU Clinical Trials Register and site verification

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