BAL2420 safety and dosing in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Basilea is conducting a randomized, double-blind, placebo-controlled Phase I study of BAL2420 in healthy adult volunteers to characterize safety, tolerability, and pharmacokinetics. Part A uses single ascending doses while Parts B and C use multiple ascending doses, with each cohort randomized to BAL2420 or matched placebo. Serial blood sampling, ECGs, and laboratory safety tests will be used to measure pharmacokinetics and detect adverse events. The study is conducted at an early clinical site in Groningen with sponsorship from Basilea and support from CARB-X.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Body mass index: 18.0 to 30.0 kg/m2, inclusive, at screening
* Total body weight: \> 50 kg at screening

Exclusion Criteria:

* Any uncontrolled or active major systemic disease,
* Active infection
* Acute illness within 5 days prior to the first study drug administration that, in the opinion of the Investigator, may impact safety assessments.
* Clinically-significant physical examination, vital signs, laboratory safety tests, or ECG abnormalities
* History of risk factors for QT prolongation or Torsades de Pointes
* QTcF (Fridericia's corrected QT interval) \> 450 msec (males) and \> 470 msec (females) at screening.
* Receipt of prescribed medication other than hormonal contraceptives within the 30 days prior to admission to the clinical site.
* Receipt of over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (e.g., St. John's wort) within 14 days prior to admission to the clinical site.
* History of relevant drug and/or food allergies, particularly to antibiotics.
* History of tobacco use or e-cigarette within the past 6 months prior to the first study drug administration.
* History of alcohol abuse or drug addiction (including soft drugs like cannabis products) within 12 months prior to screening.
* Average intake of more than 24 units of alcohol per week: one unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits.
* Positive screen for hepatitis B surface antigen, hepatitis B core antibodies, hepatitis C virus antibodies, human immunodeficiency virus 1 and 2 antibodies, or syphilis at screening. Note: Hepatitis B vaccination is allowed.

Where it's running

• ICON Early Clinical & Bioanalytical Solutions
  Groningen, Netherlands Recruiting

Study contacts

• Study coordinator: Thomas Kaindl, MD
• Email: thomas.kaindl@basilea.com
• Phone: +41615671505

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.