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CompletedPhase 1

Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of Donepezil From Single Dose of GB-5001 IM Depot and Aricept® Oral Tablets in Healthy Male Volunteers

A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of Donepezil From Single Dose of GB-5001 Intramuscular Depot and Aricept® Oral Tablets (Pfizer Canada Inc.) in Healthy Male Volunteers

Lead sponsor

G2GBio, Inc.

Asset

GB-5001

Listed sites

1

Recruiting sites

-

Enrollment

48

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Age 18-55•Male

Primary endpoints

•Incidence, severity, and dose-relationship of AEs•Vital signs•Electrocardiograms

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

Org study IDG2GBio
NCT IDNCT05525780

Timeline

Milestones

Study start2022-08-26actual
Study first posted2022-09-02actual
Primary completion2023-06-02actual
Study completion2023-06-02actual
Last update posted2023-07-13actual

Assets

Drug assets

GB-5001

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years
Maximum age55 Years
SexMale
Healthy volunteersAccepted

Inclusion criteria

•Healthy, non-smoking male volunteers, 18-55 years of age, inclusive at the time of informed consent.
•Body mass index (BMI) that is within 18.5 - 30.0 kg/m2, inclusive, and weight at least 55 kg and above.
•Healthy, according to the medical history, ECG, vital signs, laboratory results and physical examination as determined by the PI/Sub-Investigator.
•Systolic blood pressure between 95-140 mmHg, inclusive, and diastolic blood pressure between 55-90 mmHg, inclusive, and heart rate between 60-100 bpm, inclusive, unless deemed otherwise by the PI/Sub-Investigator.
•Clinical laboratory values within the clinical site's most recent acceptable laboratory test range, and/or values are deemed by the PI/Sub-Investigator as "Not Clinically Significant"

Exclusion criteria

•Known history or presence of any clinically significant hepatic, renal/genitourinary, gastrointestinal, cardiovascular, cerebrovascular, pulmonary, endocrine, immunological, musculoskeletal, neurological, psychiatric, dermatological or hematological disease or condition unless determined as not clinically significant by the PI/Sub-Investigator.
•Known history or presence of seizure or convulsion, unless determined as not clinically significant by the PI/Sub-Investigator.
•Known history or presence of peptic ulcer or gastrointestinal bleeding within 3 months prior to study drug administration, unless determined as not clinically significant by the PI/Sub-Investigator.
•Known risk of developing ulcers (for example, if you are taking non-steroidal anti-inflammatory drugs [NSAIDS] or high doses of acetylsalicylic acid [ASA] [Aspirin®]), unless determined as not clinically significant by the PI/Sub-Investigator.
•Clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g., chronic diarrhea, inflammatory bowel disease), unresolved gastrointestinal symptoms, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug experienced within 7 days prior to study drug administration, as determined by the PI/Sub-Investigator.
•Presence of any clinically significant illness within 30 days prior to dosing, as determined by the PI/Sub-Investigator
•Presence of any clinically significant illness within 30 days prior to dosing, as determined by the PI/Sub-Investigator.

Endpoints (10)

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.

Coverage by outcome category

Safety / tolerability / PK
5
Other (unclassified)
5

Safety / tolerability / PK

5 endpoints
Primary/protocol endpoint

Vital signs

Time frame:Day 64

descriptive

Secondary/protocol endpoint

Key PK parameters for single dose IM and Oral cohorts

Time frame:Day 64

concentration, descriptive

Secondary/protocol endpoint

Key PK parameters for single dose IM and Oral cohorts

Time frame:Day 64

concentration, descriptive

Secondary/protocol endpoint

Key PK parameters for single dose IM and Oral cohorts

Time frame:Day 64

time to event, event

Secondary/protocol endpoint

Key PK parameters for single dose IM and Oral cohorts

Time frame:Day 64

concentration, descriptive

Other (unclassified)

5 endpoints
Primary/protocol endpoint/low confidence

Incidence, severity, and dose-relationship of AEs

Time frame:Day 64

event count, event

Primary/protocol endpoint/low confidence

Electrocardiograms

Time frame:Day 64

descriptive

Primary/protocol endpoint/low confidence

Physical examination

Time frame:Day 64

descriptive

Primary/protocol endpoint/low confidence

Injection site assessments

Time frame:Day 64

descriptive

Secondary/protocol endpoint/low confidence

Key PK parameters for single dose IM and Oral cohorts

Time frame:Day 64

descriptive

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.