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.

Tracking Information

• First Submitted Date: September 30, 2019
• First Posted Date: October 1, 2019
• Last Update Posted Date: August 10, 2022
• Actual Study Start Date: December 14, 2019
• Actual Primary Completion Date: June 9, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 17, 2021)

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.

Original Primary Outcome Measures (submitted: September 30, 2019)

Evaluation of safety and tolerability of AL101 measured by number of subjects with adverse events and Dose Limiting Adverse Event (DLAEs) [ Time Frame: 85 days ]

Incidence of adverse events and dose limiting Adverse Events during the DLAE observation period and/or study treatment periods.

Current Secondary Outcome Measures (submitted: December 17, 2021)

• 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
• 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
• 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

Original Secondary Outcome Measures (submitted: September 30, 2019)

• Pharmacokinetics (PK) of AL101 [ Time Frame: 85 days ]
  Serum and CSF concentration of AL101 at specified time points
• Maximum plasma concentration (Cmax) for AL101 [ Time Frame: 85 days ]
  Evaluate Cmax for serum and CSF concentration of AL101 at specified time points
• Area under the curve concentration (AUC) for AL101 [ Time Frame: 85 days ]
  Evaluate AUC for serum and CSF concentration of AL101 at specified time points

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Phase 1 First in Human Study to Assess Safety and Tolerability of AL101
• Official Title: A Phase 1 Study in Healthy Volunteers to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Bioavailability of IV and SC AL101
• 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 Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Healthy

Intervention

• Biological: AL101
  Active dose of AL101
• Other: Placebo
  Saline solution administered as a single and multiple infusion as placebo.

Study Arms

• Experimental: AL101 IV
  • Up to four single ascending doses (SAD IV cohorts)
  • Multiple doses of AL101 administered IV (MD IV cohort)
  Intervention: Biological: 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
  Intervention: Other: Placebo
• Experimental: AL101 SC
  • Single fixed dose levels of AL101 administered SC
  • Multiple fixed dose of AL101 administered SC
  Intervention: Biological: AL101

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 9, 2022): 88
• Original Estimated Enrollment (submitted: September 30, 2019): 42
• Actual Study Completion Date: June 9, 2022
• Actual Primary Completion Date: June 9, 2022 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04111666
• Other Study ID Numbers: AL101-1
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Alector Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Alector Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Alector Inc.
• Verification Date: May 2022