A Phase 1 interventional study of AL101 and Placebo in Healthy, sponsored by Alector Inc.. Completed at 2 sites in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-10.
Sponsored by Alector Inc. · Phase 1, Interventional, and Treatment
A first in human phase 1 study in healthy volunteers to assess AL101 safety, tolerability, bioavailability, pharmacokinetics, and pharmacodynamics
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.
Alector Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
* Up to four single ascending doses (SAD IV cohorts) * Multiple doses of AL101 administered IV (MD IV cohort)
Biological: AL101
Saline solution will be administered with the following: * Single IV infusion for four single ascending doses (SAD IV cohorts) in a ratio of 8 active and 3 placebo subjects * Multiple IV infusions for the MD IV cohort in a ratio of 8 active and 2 placebo subjects
Other: Placebo
* Single fixed dose levels of AL101 administered SC * Multiple fixed dose of AL101 administered SC
Biological: AL101
Active dose of AL101
Saline solution administered as a single and multiple infusion as placebo.
Evaluation of safety and tolerability of AL101 measured by number of subjects with adverse events and Dose Limiting Adverse Event (DLAEs)
Incidence of adverse events and dose limiting Adverse Events during the DLAE observation period and/or study treatment periods.
Time frame: either 57, 113, or 141 days, depending on the cohort
Pharmacokinetics (PK) of AL101
Serum and CSF concentration of AL101 at specified time points
Time frame: either 57, 113, or 141 days, depending on the cohort
Maximum plasma concentration (Cmax) for AL101
Evaluate Cmax for serum and CSF concentration of AL101 at specified time points
Time frame: either 57, 113, or 141 days, depending on the cohort
Area under the curve concentration (AUC) for AL101
Evaluate AUC for serum and CSF concentration of AL101 at specified time points
Time frame: either 57, 113, or 141 days, depending on the cohort
Plan to share: No
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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Alector Inc.