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

Alector

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Biological: AL101; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04111666

AL101-1

Details and patient eligibility

About

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

Full 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.

Enrollment: 88 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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88 participants in 3 patient groups, including a placebo group

AL101 IV

Experimental group

Description:

* Up to four single ascending doses (SAD IV cohorts) * Multiple doses of AL101 administered IV (MD IV cohort)

Treatment:

Biological: AL101

Saline Solution

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo

AL101 SC

Experimental group

Description:

* Single fixed dose levels of AL101 administered SC * Multiple fixed dose of AL101 administered SC

Treatment:

Biological: AL101