NCT03636204CompletedPhase 1
A First in Human Phase 1 Study in Healthy Volunteers and in Participants With Frontotemporal Dementia (FTD) With Granulin Mutation
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Alector Inc.
- Enrollment
- 64
- Locations
- 14
- Primary Endpoint
- Evaluation of safety and tolerability of AL001 measured by number of subjects with adverse events and Dose Limiting Adverse Event (DLAEs)
Study Overview
Brief Summary
A first in human phase 1 study in healthy volunteers and participants with Granulin (GRN) mutation causative of frontotemporal dementia (FTD) to assess AL001 safety, tolerability, pharmacokinetics, and pharmacodynamics
Detailed Description
This is a first-in-human Phase 1 study designed to investigate the safety, tolerability, PK and PD of intravenously administered AL001 in Healthy Volunteers and FTD-GRN mutation carriers.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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
Incidence of adverse events and dose limiting Adverse Events during the DLAE observation period and/or study treatment periods.
Secondary Outcomes
- Pharmacokinetics (PK) of AL001(85 days)
- Maximum plasma concentration (Cmax) for AL001(85 days)
- Area under the curve concentration (AUC) for AL001(85 days)
Investigators
Study Sites (14)
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