Active not recruitingPhase 1

A Study to Assess THN391 in Subjects With Alzheimer's Disease

A Double-blind, Randomized, Placebo-controlled, Phase 1b Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of THN391 in Early Alzheimer's Disease Subjects

Lead sponsor

Therini Bio, Inc.

Asset

THN391

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoints

•Safety and tolerability of multiple doses of THN391 in Early AD subjects•Pharmacokinetics (PK) of multiple doses of THN391 in Early AD subjects•Cmax for THN391 in Early AD subjects

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

Ctis2024-519899-72-00

NCT IDNCT06814730

Org study IDTHN391-NEU-102

Timeline

Milestones

Study first posted2025-02-07actual

Study start2025-07-17actual

Last update posted2026-07-08actual

Primary completion2027-03-31estimated

Study completion2027-05-31estimated

Assets

Drug assets

THN391

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age60 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity

•60 to 85 years of age (inclusive at the time of informed consent).

•Diagnosis of Early Alzheimer's Disease (AD)

•Diagnosis of cerebral Small Vessel Disease (cSVD), and having at least one of the following vascular risk factors: hypertension, Type 2 diabetes mellitus, or hyperlipidemia

Exclusion criteria

•Diagnosis of moderate or severe dementia

•Any other medical condition except for early AD (e.g. any clinically significant neurological, psychiatric or large vessel disease) that could affect interpretation of study assessments

•Use of anticoagulant, except for either clopidogrel or low dose aspirin, unless taken simultaneously

Endpoints (11)

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

Fluid / digital biomarkers

Other (unclassified)

Safety / tolerability / PK

Fluid / digital biomarkers

4 endpoints

Primary/protocol endpoint

To assess the pharmacokinetics (PK) of multiple doses of THN391 in Early AD subjects

Time frame:From the first dosing to the end of the follow-up period (6 months post dosing)

concentration, descriptive

Primary/protocol endpoint

To assess the maximum plasma concentration (Cmax) for THN391 in Early AD subjects

Time frame:From the first dosing to the end of the follow-up period (6 months post dosing)

concentration, descriptive

Primary/protocol endpoint

To assess area under the curve concentration (AUC) for THN391 in Early AD subjects

Time frame:From the first dosing to the end of the follow-up period (6 months post dosing)

concentration, descriptive

Primary/protocol endpoint

To measure the half-life (t1/2) of THN391 in Early AD subjects

Time frame:From the first dosing to the end of the follow-up period (6 months post dosing)

concentration, descriptive

Safety / tolerability / PK

3 endpoints

Primary/protocol endpoint

To assess the safety and tolerability of multiple doses of THN391 in Early AD subjects via AEs

Time frame:From enrollment to the end of the follow-up period (6 months post dosing)

event count, event

Primary/protocol endpoint

To assess the safety and tolerability of multiple doses of THN391 in Early AD subjects via SAEs

Time frame:From enrollment to the end of the follow-up period (6 months post dosing)

event count, event

Secondary/protocol endpoint

To assess the immunogenicity of multiple doses of THN391 in Early AD subjects

Time frame:From the first dosing to the end of the follow-up period (6 months post dosing)

descriptive

Other (unclassified)

4 endpoints

Secondary/protocol endpoint/low confidence

To assess the effects of THN391 on coagulation in Early AD subjects via aPTT

Time frame:From enrollment to the end of the follow-up period (6 months post dosing)

descriptive

Secondary/protocol endpoint/low confidence

To assess the effects of THN391 on coagulation in Early AD subjects via INR

Time frame:From enrollment to the end of the follow-up period (6 months post dosing)

ratio, descriptive

Secondary/protocol endpoint/low confidence

To assess the effects of THN391 on coagulation in Early AD subjects via PT

Time frame:From enrollment to the end of the follow-up period (6 months dosing)

descriptive

Secondary/protocol endpoint/low confidence

To assess the effects of THN391 on coagulation in Early AD subjects via platelet counts

Time frame:From enrollment to the end of the follow-up period (6 months post dosing)

descriptive

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.