Skip to main content
Delfa

← Trials/Trial dossier/NCT03636204

CompletedPhase 1

A First in Human Study in Healthy Volunteers and in Participants With Frontotemporal Dementia With Granulin (GRN) Mutation

A First in Human Phase 1 Study in Healthy Volunteers and in Participants With Frontotemporal Dementia (FTD) With Granulin Mutation

Lead sponsor

Alector Inc.

Asset

Latozinemab

Listed sites

8

Recruiting sites

-

Enrollment

64

actual

Study population

Frontotemporal dementia

Key I/E criterion

•Age 18-80

Primary endpoint

•Evaluation of safety and tolerability of AL001

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 IDAL001-1
NCT IDNCT03636204

Timeline

Milestones

Study first posted2018-08-17actual
Study start2018-09-14actual
Primary completion2019-12-31actual
Study completion2019-12-31actual
Last update posted2020-07-27actual

Assets

Drug assets

Latozinemab

Study populations

Who this study enrolls

Frontotemporal dementia

Eligibility

Who can enroll

Minimum age18 Years
Maximum age80 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•BMI 18.0-35.0 kg/m2
•45-120 kg, inclusive
•At screening, females must be non-pregnant and non-lactating, or of nonchildbearing potential (either surgically sterilized or physiologically incapable of becoming pregnant, or at least 1-year postmenopausal (amenorrhoea duration of 12 consecutive months); nonpregnancy will be confirmed for all females by a pregnancy test conducted at screening, (each) admission, and at follow-up.
•Female participants of child-bearing potential must agree to use adequate contraception from screening until 90 days after the follow-up visit.
•In good physical health on the basis of no clinically significant findings from medical history, physical examination (PE), laboratory tests, 12 lead ECG, and vital signs, as judged by the Investigator.
•Willingness and able to comply with the study protocol, in the investigator's judgement

Exclusion criteria

•Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins.
•Positive drug or alcohol at screening and prior to first dose
•History of alcohol abuse or substance abuse

Endpoints (4)

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
3
Safety / tolerability / PK
1

Fluid / digital biomarkers

3 endpoints
Secondary/protocol endpoint

Pharmacokinetics (PK) of AL001

Time frame:85 days

concentration, descriptive

Secondary/protocol endpoint

Maximum plasma concentration (Cmax) for AL001

Time frame:85 days

concentration, descriptive

Secondary/protocol endpoint

Area under the curve concentration (AUC) for AL001

Time frame:85 days

concentration, descriptive

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Evaluation of safety and tolerability of AL001 measured by number of subjects with adverse events and Dose Limiting Adverse Event (DLAEs)

Time frame:85 days

event count, 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.