A Phase 1 First in Human Study to Assess Safety and Tolerability of AL101

Phase 1

Completed

• Conditions: Healthy
• Interventions: Biological: AL101; Other: Placebo

• Registration Number: NCT04111666
• Lead Sponsor: Alector Inc.

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.

Study Timeline

• Study First Submitted: 2019-09-30
• Study First Submitted QC: 2019-09-30
• Study First Posted: 2019-10-01
• Study Start: 2019-12-14
• Status Verified: 2022-05
• Primary Completion: 2022-06-09
• Study Completion: 2022-06-09
• Last Update Submitted: 2022-08-09
• Last Update Posted: 2022-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AL101 SC	AL101	* Single fixed dose levels of AL101 administered SC * Multiple fixed dose of AL101 administered SC
AL101 IV	AL101	* Up to four single ascending doses (SAD IV cohorts) * Multiple doses of AL101 administered IV (MD IV cohort)
Saline Solution	Placebo	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

Primary Outcome Measures

Name	Time	Method
Evaluation of safety and tolerability of AL101 measured by number of subjects with adverse events and Dose Limiting Adverse Event (DLAEs)	either 57, 113, or 141 days, depending on the cohort	Incidence of adverse events and dose limiting Adverse Events during the DLAE observation period and/or study treatment periods.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK) of AL101	either 57, 113, or 141 days, depending on the cohort	Serum and CSF concentration of AL101 at specified time points
Area under the curve concentration (AUC) for AL101	either 57, 113, or 141 days, depending on the cohort	Evaluate AUC for serum and CSF concentration of AL101 at specified time points
Maximum plasma concentration (Cmax) for AL101	either 57, 113, or 141 days, depending on the cohort	Evaluate Cmax for serum and CSF concentration of AL101 at specified time points

Trial Locations

Locations (1)

Study site; 🇺🇸 Orlando, Florida, United States