CLINICAL TRIALS PROFILE FOR AV-101

Clinical Trials for AV-101

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT01483846 ↗	Safety, Tolerability and Pharmacokinetics of Multiple Doses of AV-101 in Healthy Volunteers	Completed	Cato Research	Phase 1	This is a Phase 1b study involving multiple oral doses of AV-101 in healthy male and female subjects. The safety, pharmacokinetics, and antihyperalgesic effect of AV-101 on capsaicin-induced hyperalgesia will be assessed.
NCT01483846 ↗	Safety, Tolerability and Pharmacokinetics of Multiple Doses of AV-101 in Healthy Volunteers	Completed	National Institute on Drug Abuse (NIDA)	Phase 1	This is a Phase 1b study involving multiple oral doses of AV-101 in healthy male and female subjects. The safety, pharmacokinetics, and antihyperalgesic effect of AV-101 on capsaicin-induced hyperalgesia will be assessed.
NCT01483846 ↗	Safety, Tolerability and Pharmacokinetics of Multiple Doses of AV-101 in Healthy Volunteers	Completed	VistaGen Therapeutics, Inc.	Phase 1	This is a Phase 1b study involving multiple oral doses of AV-101 in healthy male and female subjects. The safety, pharmacokinetics, and antihyperalgesic effect of AV-101 on capsaicin-induced hyperalgesia will be assessed.

Clinical Trial Conditions for AV-101

Condition Name

Condition Name
Intervention	Trials
Pulmonary Arterial Hypertension	2
Drug Drug Interaction	1
Dyskinesia, Medication-Induced	1

Condition MeSH

Condition MeSH
Intervention	Trials
Depressive Disorder, Major	2
Pulmonary Arterial Hypertension	2
Depressive Disorder	2

Clinical Trial Locations for AV-101

Trials by Country

Trials by Country
Location	Trials
United States	17

Trials by US State

Trials by US State
Location	Trials
California	3
Texas	2
Maryland	2
Washington	1
Pennsylvania	1

Clinical Trial Progress for AV-101

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
Phase 2/Phase 3	2
Phase 2	3
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Completed	4
Not yet recruiting	3
Recruiting	1

Clinical Trial Sponsors for AV-101

Sponsor Name

Sponsor Name
Sponsor	Trials
VistaGen Therapeutics, Inc.	5
Aerovate Therapeutics	2
Michael Debakey Veterans Affairs Medical Center	1

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	9
U.S. Fed	2
NIH	2