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Completed

NCT Number: NCT04111666

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

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

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Study site, Miami, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AL101

Biological

Active dose of AL101

Placebo

Other

Saline solution administered as a single and multiple infusion as placebo.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Alector Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 1, 2019
Registry last updated
Aug 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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