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
This trial accepts healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
AVR-48
DrugInvestigational drug reconstituted in normal saline will be administered via IV
Placebo
DrugNormal saline will be administered via IV
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: Drug: AVR-48Experimental treatment 1 intervention
Group B: Drug: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants who experience Adverse Events (AEs), Serious Adverse Events
Number of AEs, SAEs, and discontinuation due to AEs
Time frame
Up to 16 days2
Number of participants who experience ECG abnormalities
Number of participants with potentially clinically significant ECG readings
Time frame
Up to 16 days3
Number of participants who experience vital sign abnormalities
Number of participants with potentially clinically significant vital sign values
Time frame
Up to 16 days4
Number of participants who experience laboratory test abnormalities
Number of participants with potentially clinically significant laboratory test results
Time frame
Up to 16 daysSecondary outcomes
1
PK of AVR-48 in plasma: Area under the plasma-concentration time curve (AUC)
Blood Samples will be collected for plasma analysis
Time frame
Up to 8 days2
Title: PK of AVR-48 in plasma: Area under the concentration time curve, from time 0 to the last observed non-zero concentration (AUC0-tlast)
Blood Samples will be collected for plasma analysis
Time frame
Up to 8 days3
PK of AVR-48 in plasma: Maximum observed concentration (Cmax)
Blood Samples will be collected for plasma analysis
Time frame
Up to 8 days4
PK of AVR-48 in plasma: Trough or minimum concentration (Ctrough)
Blood Samples will be collected for plasma analysis
Time frame
Up to 8 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
AyuVis Research, Inc.
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: