NCT07605806 Novel Biomarkers of Non-IgE Immediate Hypersensitivity Drug Reactions
| NCT ID | NCT07605806 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Johns Hopkins University |
| Condition | Healthy Volunteer |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2026-05-21 |
| Primary Completion | 2027-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 25 participants in total. It began in 2026-05-21 with a primary completion date of 2027-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to investigate biomarkers of non-IgE-mediated immediate hypersensitivity reactions during infusion of intravenous vancomycin. The main question it aims to answer is: • Identifying novel biomarkers in blood that occur during infusion reaction Participants will: * Have allergy skin testing for vancomycin * Receive an infusion of vancomycin
Eligibility Criteria
Inclusion Criteria: * Male or female age ≥ 18 years. * Adequate kidney function as defined by creatinine level within normal institutional limits at the participant's first visit. * Women of child bearing potential must agree to a reliable form of highly effective contraception (hormonal, device, or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 7 days following completion of vancomycin therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform the Principal Investigator and her treating physician immediately. * Ability to understand and the willingness to sign a written informed consent. * Ability to clearly understand and speak English at an 8th grade reading level. For safety reasons, participants must speak English due to the anticipated need for clear and timely communication with investigators and the study team in emergency situations, since the investigators and study team are English speaking. Exclusion Criteria: * Participants who have previously received vancomycin in any formulation, including oral or intravenous. * History of allergic reactions to study drug or reactions attributed to compounds of similar chemical or biologic composition to vancomycin, including active product or excipients. * Concurrent use of medications thought to cause non-specific mast cell activation (e.g. opioids) * Baseline serum tryptase over 8.0 ng/mL and/or known mast cell disorder, including, but not limited to, mastocytosis, idiopathic mast cell activation syndrome, and hereditary alpha tryptasemia * Active infection or immunodeficiency * Unstable cardiovascular disease * Renal insufficiency * Current hearing deficit * Current use of beta-blockers * Use of immunomodulatory therapies or oral corticosteroids within the previous 1 month * Use of biologics in the previous 6 months, including omalizumab * Participants taking antihistamines must stop these drugs for one week prior to enrollment and must refrain from taking antihistamines during the duration of the study so as not to interfere with responses during drug challenge
Contact & Investigator
Melanie Dispenza, MD, PhD
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT07605806 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Healthy Volunteer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07605806 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07605806 currently recruiting?
Yes, NCT07605806 is actively recruiting participants. Contact the research team at jhoffm45@jh.edu for enrollment information.
Where is the NCT07605806 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT07605806 clinical trial?
NCT07605806 is sponsored by Johns Hopkins University. The principal investigator is Melanie Dispenza, MD, PhD at Johns Hopkins University. The trial plans to enroll 25 participants.