A Single and Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of PU-AD in Healthy Subjects

PU-AD-01-001

This is a first in human Phase 1 study in two parts with healthy volunteers receiving a single dose of PU AD in three small cohorts and a multiple ascending dose in two small cohorts.

2019-06-24

2019-12-23

2019-12-23

Terminated

Early phase I

40

Inclusion Criteria: 1. Male or female (Women of non-child bearing potential) 2. 18 to 60 years of age for part one, \>/= 60 years of age for part two Exclusion Criteria: 1. Women of child bearing potential or Female with positive pregnancy test or who is lactating. 2. History or presence of conditions, which in the judgment of the PI, are known to interfere with the absorption distribution, metabolism, or excretion of drugs. 3. History or presence of conditions that may place the subject at increased risk as determined by the PI. 4. Has taken other investigational drugs or participated in any clinical study within 30 days. 5. Any other condition or prior therapy that, in the PI's opinion, would make the subject unsuitable for the study, or unable or unwilling to comply with the study procedures

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ACTUAL'}}

2023-04-18