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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04111666
Recruitment Status : Completed
First Posted : October 1, 2019
Last Update Posted : August 10, 2022
Sponsor:
Information provided by (Responsible Party):
Alector Inc.

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.

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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

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




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04111666


Locations
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United States, Florida
Study site
Miami, Florida, United States, 33126
Study site
Orlando, Florida, United States, 32806
Sponsors and Collaborators
Alector Inc.
Investigators
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Principal Investigator: Jorge Kusnir Bioclinica Research
Principal Investigator: Maria Bermudez Quotient Sciences
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Responsible Party: Alector Inc.
ClinicalTrials.gov Identifier: NCT04111666    
Other Study ID Numbers: AL101-1
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: August 10, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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