A Phase I, Single-Center, Open-Label, Dose-Escalation Clinical Trial to Assess the Safety and Tolerability of an Intranasal Memory T Lymphocytes Solution in Adult Females: vRELEASE I. (vRELEASE I)

Launched by CRISTINA CALVO REY · Nov 19, 2024

Keywords

ClinConnect Summary

The vRELEASE I clinical trial is studying the safety and tolerability of a new treatment that involves using a solution of memory T lymphocytes from male donors. This treatment will be given through the nose (intranasally) to adult females aged 18 to 55 years. The goal is to see if this method of delivery is safe for healthy women in this age group.

To participate in this trial, women need to be in good health and not currently taking any medications or being treated for other medical conditions. Participants must also be able to attend all scheduled visits and follow the study guidelines. If someone is interested in joining, they will first need to provide written consent after learning about the study. Since this is an early phase trial, participants will help researchers understand how well this new treatment works and whether it is safe to use.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Female subjects between 18 - 55 years of age.
• • Participants are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
• • Patients with the ability to comprehend and sign the informed consent.
• • Written informed consent obtained prior to any screening procedures.
• • Subjects in good health with no baseline disease of any kind.
• Exclusion Criteria:
• • Participants are not willing or able to comply with either: all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, or other study procedures.
• • Participants who are currently under medical follow-up for any medical condition or who are regularly taking medication for any condition.
• • Subject has experienced symptoms consistent with a respiratory infection within the 7 days prior to the administration of the investigational treatment.
• • Have a known history of human immunodeficiency virus infection, Hepatitis B or Hepatitis C; testing is not required in the absence of prior documentation or known history.
• • Have a known history of drug substance abuse.
• • Pregnant or breastfeeding women, where pregnancy is defined as the state of a female after conception and until the termination of gestation.
• • Any other condition that, in the opinion if the Investigator, may interfere with the efficacy and/or safety evaluation of the trial.
• • Any condition or situation precluding or interfering with the compliance with the protocol.
• • Participant is currently enrolled or has enrolled in a clinical trial three months prior to inclusion in the current study.