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

NCT04111666 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: AL101-1
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Evaluation of safety and tolerability of AL101 measured by number of subjects with adverse events and Dose Limiting Adverse Event (DLAEs)

  Incidence of adverse events and dose limiting Adverse Events during the DLAE observation period and/or study treatment periods.

  either 57, 113, or 141 days, depending on the cohort

Secondary Outcomes (3)

• Pharmacokinetics (PK) of AL101

  either 57, 113, or 141 days, depending on the cohort

• Maximum plasma concentration (Cmax) for AL101

  either 57, 113, or 141 days, depending on the cohort

• Area under the curve concentration (AUC) for AL101

  either 57, 113, or 141 days, depending on the cohort

Study Arms (3)

AL101 IV

EXPERIMENTAL

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

Biological: AL101

Saline Solution

PLACEBO COMPARATOR

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

AL101 SC

EXPERIMENTAL

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

Biological: AL101

Interventions

AL101 BIOLOGICAL

Active dose of AL101

AL101 IV; AL101 SC

Placebo OTHER

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

Saline Solution

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI 18.0-35.0 kg/m2
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Alector Inc.: lead

Study Sites (2)

Study site

Miami, Florida, 33126, United States

Location

Study site

Orlando, Florida, 32806, United States

Location

Related Publications (1)

• Budda B, Mitra A, Park L, Long H, Kurnellas M, Bien-Ly N, Estacio W, Burgess B, Chao G, Schwabe T, Paul R, Kenkare-Mitra S, Rosenthal A. Development of AL101 (GSK4527226), a progranulin-elevating monoclonal antibody, as a potential treatment for Alzheimer's disease. Alzheimers Res Ther. 2025 Jul 25;17(1):174. doi: 10.1186/s13195-025-01817-4.

  PMID: 40713730 DERIVED

Study Officials

• Jorge Kusnir

  Bioclinica Research

  PRINCIPAL INVESTIGATOR

• Maria Bermudez

  Quotient Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 1, 2019
• Study Start: December 14, 2019
• Primary Completion: June 9, 2022
• Study Completion: June 9, 2022
• Last Updated: August 10, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)