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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04111666
Recruitment Status : Recruiting
First Posted : October 1, 2019
Last Update Posted : February 25, 2021
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)
Estimated Enrollment : 53 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
Estimated Primary Completion Date : August 19, 2021
Estimated Study Completion Date : October 14, 2021

Arm Intervention/treatment
Experimental: AL101 IV
Up to four single ascending doses of AL101 administered IV
Biological: AL101
Active dose of AL101

Placebo Comparator: Saline Solution
Saline solution will be administered as a single infusion for each cohort in a ratio of 8 active and 3 placebo subjects
Other: Placebo
Saline solution administered as a single infusion as palcebo.

Experimental: AL101 SC
A single 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: 113 days ]
    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: 113 days ]
    Serum and CSF concentration of AL101 at specified time points

  2. Maximum plasma concentration (Cmax) for AL101 [ Time Frame: 113 days ]
    Evaluate Cmax for serum and CSF concentration of AL101 at specified time points

  3. Area under the curve concentration (AUC) for AL101 [ Time Frame: 113 days ]
    Evaluate AUC for serum and CSF concentration of AL101 at specified time points

Information from the National Library of Medicine

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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

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 identifier (NCT number): NCT04111666

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Contact: Study Lead 650-422-7435

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United States, Florida
Study site Recruiting
Orlando, Florida, United States, 32806
Contact: Study Coordinator    407-841-0502   
Sponsors and Collaborators
Alector Inc.
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Principal Investigator: Jorge Kusnir Bioclinica Research
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Responsible Party: Alector Inc. Identifier: NCT04111666    
Other Study ID Numbers: AL101-1
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: February 25, 2021
Last Verified: February 2021
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