Orlando, Florida 32806


Purpose:

A first in human phase 1 study in healthy volunteers and Granulin mutation causative of frontotemporal dementia to assess AL001 safety, tolerability, pharmacokinetics, and pharmacodynamics


Study summary:

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 asymptomatic FTD-GRN mutation carriers.


Criteria:

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. A - 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


NCT ID:

NCT03636204


Primary Contact:

Principal Investigator
George Stoica
Bioclinica Research

Study Lead
Phone: 4152315660 ext. 328
Email: info@alector.com


Backup Contact:

N/A


Location Contact:

Orlando, Florida 32806
United States

Study Coordinator
Phone: 407-841-0502
Email: info@bioclinicaresearch.com

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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