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

• ClinicalTrials.gov Identifier: NCT04111666
• Recruitment Status: Completed
• First Posted: October 1, 2019
• Last Update Posted: August 10, 2022
• Sponsor: Alector Inc.
• Information provided by (Responsible Party): Alector Inc.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Healthy	Biological: AL101; Other: Placebo	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 88 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 1 Study in Healthy Volunteers to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Bioavailability of IV and SC AL101
• Actual Study Start Date: December 14, 2019
• Actual Primary Completion Date: June 9, 2022
• Actual Study Completion Date: June 9, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Evaluation of safety and tolerability of AL101 measured by number of subjects with adverse events and Dose Limiting Adverse Event (DLAEs) [ Time Frame: 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 :

1. Pharmacokinetics (PK) of AL101 [ Time Frame: either 57, 113, or 141 days, depending on the cohort ]
   Serum and CSF concentration of AL101 at specified time points
2. Maximum plasma concentration (Cmax) for AL101 [ Time Frame: either 57, 113, or 141 days, depending on the cohort ]
   Evaluate Cmax for serum and CSF concentration of AL101 at specified time points
3. Area under the curve concentration (AUC) for AL101 [ Time Frame: either 57, 113, or 141 days, depending on the cohort ]
   Evaluate AUC for serum and CSF concentration of AL101 at specified time points

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Florida

Study site

Miami, Florida, United States, 33126

Study site

Orlando, Florida, United States, 32806

Sponsors and Collaborators

Alector Inc.

Investigators

• Principal Investigator: Jorge Kusnir; Bioclinica Research
• Principal Investigator: Maria Bermudez; Quotient Sciences

More Information

• Responsible Party: Alector Inc.
• ClinicalTrials.gov Identifier: NCT04111666
• Other Study ID Numbers: AL101-1
• First Posted: October 1, 2019
• Last Update Posted: August 10, 2022
• Last Verified: May 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No