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TerminatedPhase 1

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

Asset

PU-AD

Listed sites

1

Recruiting sites

-

Enrollment

40

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age 18-75

Primary endpoint

•Safety and tolerability of single

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03935568
Org study IDPU-AD-01-001

Timeline

Milestones

Study first posted2019-05-02actual
Study start2019-06-24actual
Primary completion2019-12-23actual
Study completion2019-12-23actual
Last update posted2023-04-18actual

Assets

Drug assets

PU-AD

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersAccepted

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

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

6 endpoints
Primary/protocol endpoint

To evaluate the safety and tolerability of single and multiple doses of PU-AD in healthy subjects

Time frame:Day 1 to Day 3

threshold achievement, event

Primary/protocol endpoint

To evaluate the safety and tolerability of single and multiple doses of PU-AD in healthy subjects

Time frame:Day 1 to Day 3

threshold achievement, event

Primary/protocol endpoint

To evaluate the safety and tolerability of single and multiple doses of PU-AD in healthy subjects

Time frame:Day 1 to Day 3

threshold achievement, event

Secondary/protocol endpoint

To determine the pharmacokinetics (PK) PU-AD in healthy subjects

Time frame:Day 1 to Day 3

threshold achievement, event

Secondary/protocol endpoint

To determine the pharmacokinetics (PK) PU-AD in healthy subjects

Time frame:Day 1 to Day 3

time to event, event

Secondary/protocol endpoint

To determine the pharmacokinetics (PK) PU-AD in healthy subjects

Time frame:Day 1 to Day 3

threshold achievement, event

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.