Phase I Study to Evaluate the Safety and Pharmacokinetics of Oral Doses of Anvylic-3288 in Healthy Subjects

AVL-3288, a "first in class" small molecule, selective allosteric modulator of the α7 nAChR,
is implicated in the cognitive deficit in patients with neurologic and psychiatric
disorders, including schizophrenia, Alzheimer's disease and attention deficit hyperactivity
disorder. The mechanism of action, the allosteric modulation of α7 nAChR and improvement of
cognitive and memory function both in relevant animal models and patients has been clearly
described in recent literature. The effect of AVL-3288 strongly supports the rationale for
use in schizophrenia given the dose effect relationship, peaking at a low dose in rats (HED
3 mg), in rodent schizophrenia and memory models. Phase I, single-center, inpatient,
randomized, double-blind, placebo-controlled, dose escalating study to evaluate the safety,
tolerability and pharmacokinetic profiles of single oral doses of AVL-3288 in healthy
subjects. Subjects will be hospitalized in the University of Colorado Clinical Research
Center (CTSA) for a 12 hour period after the single dose. Then there will be an ambulatory
24 and 48 hour observation and washout period of 10. Patients will receive an evoked
potential measurement, the P50 sensory gating paradigm, and the Repeatable Battery for
Assessment of Neuropsychological Status.

Inclusion Criteria:

- Healthy volunteer

Exclusion Criteria:

- Substance use. We do not accept inquiries by email.