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Keep this study
Lead
Alector Inc.
This is a first-in-human Phase 1 study designed to investigate the safety, tolerability, PK, PD and Bioavailability of intravenously and sub-cutaneously administered AL101 in Healthy Volunteers.
Age
18–65
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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.
You may not be if
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
Clareo Health | A Phase 1 First in Human Study to Assess Safety and Tolerability of AL101