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Safety and Pharmacokinetics of MIB2 (StaphAcute) in Healthy Volunteers and Patients with Staphylococcus aureus Bacteremia

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What is this trial about?

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

The study focuses on Staphylococcus aureus bacteremia, a serious infection where the bacteria enter the bloodstream. Some cases involve bacteria that respond to regular antibiotics (MSSA), while others involve strains that are resistant to methicillin (MRSA). The investigational medicine being tested is StaphAcute, a solution given by intravenous infusion (medicine delivered through a vein). The purpose of the study is to assess the safety and how the drug moves through the body (pharmacokinetics), meaning how it is absorbed, spread, broken down and removed.

In the first part of the trial, healthy volunteers receive a single infusion of the study drug at gradually higher doses to find the highest dose that can be given without serious problems. In the second part, patients who have the bloodstream infection and are already receiving standard antibiotic treatment receive one infusion of the study drug while doctors watch for any side effects and take blood samples to understand how long the drug stays in the body. Participants remain in the hospital for a short monitoring period and later return for follow‑up visits to check recovery and any later health issues.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline assessment

    After joining the study, personal information, medical history, and laboratory tests are recorded.

    Vital signs such as blood pressure, heart rate, and temperature are measured.

  2. Step 2

    Single intravenous infusion

    A single iv infusion of staphacute is given. the dose is calculated according to body weight, up to 20 mg per kilogram.

    The infusion is administered once through a vein over the period defined by the study protocol.

    Participants who receive the control treatment receive an iv infusion of sodium chloride (saline) in the same manner.

  3. Step 3

    Immediate safety monitoring

    After the infusion, vital signs are checked regularly for several hours.

    Health staff observe for any adverse events such as allergic reactions, fever, or changes in heart rate.

  4. Step 4

    Blood sampling for pharmacokinetics

    Blood samples are taken at multiple time points after the infusion to measure the concentration of staphacute in the blood.

    These samples help determine how the drug is processed in the body.

  5. Step 5

    Standard antibacterial therapy

    Participants with staphylococcus aureus bacteremia continue to receive the usual antibacterial medicines prescribed by their doctor.

    The study medication is given in addition to this standard care.

  6. Step 6

    Hospital stay and observation

    Patients remain in the hospital for monitoring of infection status, organ function, and any side effects.

    Daily assessments include temperature checks, blood culture results, and evaluation of respiratory support if needed.

  7. Step 7

    Follow‑up visits

    After discharge, follow‑up appointments are scheduled on day 7, day 30, and day 90.

    Each visit includes a review of any new symptoms, repeat blood cultures to confirm infection clearance, and assessment of overall health.

  8. Step 8

    Final evaluation

    On day 90, the study records whether the bacteremia has been cured, any hospital readmissions, and survival status.

    All collected data are used to evaluate the safety and effectiveness of staphacute.

Who can join the trial?

18 criteria

  • Be a healthy volunteer of any sex (Phase I).
  • Be 18 years of age or older (both Phase I and Phase IIa).
  • Provide a signed informed consent form (IC) agreeing to take part in the study.
  • Agree to use a highly effective method of birth control for three months after receiving the study drug, or have a medical condition that makes pregnancy impossible.
  • Agree to attend all required follow‑up visits during the study.
  • For Phase IIa only: Have a positive blood culture for Staphylococcus aureus (a type of bacteria) taken within 72 hours before screening.
  • For Phase IIa only: At the time the blood sample is taken, show at least two of the following signs or symptoms:
    • Shortness of breath (feeling unable to get enough air).
    • Sweating.
    • Feeling unusually tired (fatigue).
    • Pain at sites where the infection has spread.
    • Fever (body temperature taken in the mouth of 38 °C or higher).
    • Abnormal white blood cell count:
      • Leukocytosis – too many white blood cells.
      • Leukopenia – too few white blood cells.
      • Bandemia – more than 10 % immature white blood cells (called bands) in the blood.
      • Fast heart rate (tachycardia) – more than 100 beats per minute.
      • Fast breathing (tachypnea) – more than 20 breaths per minute.
      • Low blood pressure (hypotension) – systolic pressure less than 90 mm Hg.
      • For Phase IIa only: Patients may be of any sex.

Who cannot join the trial?

15 criteria

  • Pregnancy or breastfeeding – you cannot be pregnant or nursing a baby while in the study.
  • Being treated with the antibiotics dalbavancin or oritavancin for the current infection.
  • If your infection with MSSA (methicillin‑susceptible Staphylococcus aureus) or MRSA (methicillin‑resistant Staphylococcus aureus) is not being treated with the goal of curing it.
  • Having taken part in another interventional trial (a study testing a new drug, device, or test) within the past 30 days or within five half‑lives of that drug (the time it takes for half of the drug to leave your body), whichever is longer.
  • Having any medical condition that the doctor believes would make the study unsafe for you or would stop you from completing it.
  • Being an employee of the study sponsor or the research site, or being a first‑degree relative (parent, sibling, or child) of such an employee.
  • Being institutionalized because of a legal or court order.
  • Being legally unable to give consent (legally incapacitated).
  • Being sexually active in a way that could lead to pregnancy and not being willing or able to use a highly effective birth‑control method.
  • Having a relevant acute (sudden) or chronic (long‑lasting) illness, or abnormal results on routine lab tests or an ECG (a test that records the heart’s electrical activity).
  • Having a known hypersensitivity (allergic reaction) to any part of the study drug.
  • Having taken part in another study using an investigational medicinal product (IMP) within the past 12 weeks or planning to join another such study during this trial.
  • Being dependent on the principal investigator or trial staff, or having site personnel who are directly involved in the study.
  • Having been held in an institution by legal or official order.
  • Having previously received the study drug StaphAcute.
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Investigated drugs

StaphAcute is an experimental medication being tested for the first time in people. It is given through a single intravenous (IV) infusion, which means it is delivered directly into a vein using a fluid solution. In this trial, researchers are looking at how safe the drug is and how well the body handles it. The study first checks safety in healthy volunteers, then evaluates safety again in patients who have a bloodstream infection caused by Staphylococcus aureus while they are also receiving the usual antibiotic treatment. The goal is to learn whether StaphAcute can be given safely and to understand how it moves through the body.

What is already known about the treatment

  • StaphAcute

    This medication is given as a sterile solution for intravenous infusion, meaning it is slowly dripped into a vein. It is an investigational drug that is currently only being studied in early‑phase clinical trials and has not yet been approved for routine medical use. The drug is being tested for treating serious Staphylococcus aureus bloodstream infections, including both methicillin‑susceptible and methicillin‑resistant strains. It works by attaching to the bacterial protein MIB2 and stopping this protein from helping the bacteria grow, classifying it as an experimental antibacterial protein‑inhibitor.

  • Sodium Chloride

    This product is also administered by intravenous infusion as a sterile salt solution that is poured into a vein. It is a well‑known, approved medication that has been used for many decades as a basic fluid and electrolyte replacement. In this trial it serves as a placebo, but in regular medical practice it is used to restore water and salt balance in the body. Its action is simply to provide sodium and chloride ions that the body needs, and it belongs to the class of isotonic crystalloid solutions.

Investigated diseases

  • Methicillin‑susceptible Staphylococcus aureus bacteremia

    It is a bloodstream infection caused by Staphylococcus aureus that can be treated with methicillin‑type antibiotics. The bacteria enter the blood, often from a skin wound, catheter, or after surgery, and cause fever, chills, and feeling unwell. As the infection progresses, the bacteria multiply and may travel to other parts of the body such as joints, heart valves, or lungs. Blood cultures remain positive while the bacteria are present, indicating ongoing infection. Over several days the condition can become more widespread if the bacteria are not cleared.

  • Methicillin‑resistant Staphylococcus aureus bacteremia

    It is a bloodstream infection caused by Staphylococcus aureus that does not respond to methicillin‑type antibiotics. The bacteria reach the blood through similar routes, including skin lesions, intravenous lines, or surgical sites, producing fever and systemic symptoms. As the infection advances, the resistant bacteria can spread to organs such as the heart, bones, or lungs. Persistent positive blood cultures show that the bacteria are still present in the bloodstream. The infection may become more extensive over days if the bacteria are not eliminated.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-511586-10-01Protocol codeUni-Koeln-Nr-5160Estimated enrolment54 patientsSponsorUniversity Of Cologne

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