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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-14

Study Completion Date

2022-06-09

Brief Summary

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

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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AL101 IV

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

Group Type EXPERIMENTAL

AL101

Intervention Type BIOLOGICAL

Active dose of AL101

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

AL101 SC

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

Group Type EXPERIMENTAL

AL101

Intervention Type BIOLOGICAL

Active dose of AL101

Interventions

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AL101

Active dose of AL101

Intervention Type BIOLOGICAL

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes