Status:
COMPLETED
A Phase 1 First in Human Study to Assess Safety and Tolerability of AL101
Lead Sponsor:
Alector Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
A first in human phase 1 study in healthy volunteers to assess AL101 safety, tolerability, bioavailability, pharmacokinetics, and pharmacodynamics
Detailed Description
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 9 2022
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT04111666
Start Date
December 14 2019
End Date
June 9 2022
Last Update
August 10 2022
Active Locations (2)
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1
Study site
Miami, Florida, United States, 33126
2
Study site
Orlando, Florida, United States, 32806