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

A Phase 1 Study in Healthy Volunteers to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Bioavailability of IV and SC AL101

A first in human phase 1 study in healthy volunteers to assess AL101 safety, tolerability, bioavailability, pharmacokinetics, and pharmacodynamics

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Biological: AL101; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33126
      • Study Site
    • Orlando, Florida, United States, 32806
      • Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: AL101 IV; Up to four single ascending doses (SAD IV cohorts); Multiple doses of AL101 administered IV (MD IV cohort)	Biological: AL101; Active dose of AL101
PLACEBO_COMPARATOR: Saline Solution; 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; Saline solution administered as a single and multiple infusion as placebo.
EXPERIMENTAL: AL101 SC; Single fixed dose levels of AL101 administered SC; Multiple fixed dose of AL101 administered SC	Biological: AL101; Active dose of AL101

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	either 57, 113, or 141 days, depending on the cohort

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK) of AL101	Serum and CSF concentration of AL101 at specified time points	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	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	either 57, 113, or 141 days, depending on the cohort

Collaborators and Investigators

• Sponsor: Alector Inc.
• Investigators: Principal Investigator: Jorge Kusnir, Bioclinica Research; Principal Investigator: Maria Bermudez, Quotient Sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 14, 2019
• Primary Completion (ACTUAL): June 9, 2022
• Study Completion (ACTUAL): June 9, 2022

Study Registration Dates

• First Submitted: September 30, 2019
• First Submitted That Met QC Criteria: September 30, 2019
• First Posted (ACTUAL): October 1, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 10, 2022
• Last Update Submitted That Met QC Criteria: August 9, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: AL101-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No