Single Ascending Dose and Multiple Ascending Dose Study of AVR-48
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorAyuVis Research, Inc.
About this trial
This is a Phase 1 (healthy adult volunteers), 2-part, double-blind, randomized, placebo controlled trial to evaluate the safety and pharmacokinetic (PK) profiles of escalating single doses of AVR-48 versus placebo (SAD) and escalating multiple doses of AVR-48 versus placebo (MAD). SAD will be initiated first and include a sentinel dosing design. MAD will not utilize a sentinel design unless the safety monitoring committee requests the addition of sentinels. The MAD will be initiated once the lowest doses from SAD are deemed safe.
Eligibility criteria
Qualifiers
Provision of signed and dated informed consent form (ICF).
Stated willingness to comply with all study procedures and availability for the duration of the study.
Healthy adult male or female, aged 18 to 55, inclusive, at Screening.
Continuous non smoker who has not used nicotine containing products (including e- vaping) for at least 3 months prior to the first dosing and throughout the study
Disqualifiers
Are mentally or legally incapacitated or have significant emotional problems at the time of the screening visit or expected during the conduct of the study in the opinion of the PI or designee.
History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.
Trial design
Treatments tested in this trial
- AVR-48
- Placebo
Treatment groups
48 Participants
are divided into 2 treatment groupsSponsors and collaborators
AyuVis Research, Inc.
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov