HealthyPhase 1NCT04111666
A Phase 1 First in Human Study to Assess Safety and Tolerability of AL101
A Phase 1 study testing AL101 in people with Healthy, run by Alector Inc. at 2 sites in United States.
Trial summary
A first in human phase 1 study in healthy volunteers to assess AL101 safety, tolerability, bioavailability, pharmacokinetics, and pharmacodynamics Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- AL101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Dec 2019to 9 Jun 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Miami, Florida, 33126
Study site
Orlando, Florida, 32806
About this study
Official title: A Phase 1 Study in Healthy Volunteers to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Bioavailability of IV and SC AL101
A first in human phase 1 study in healthy volunteers to assess AL101 safety, tolerability, bioavailability, pharmacokinetics, and pharmacodynamics
Read the 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.
- Conditions
- Healthy
- Being tested
- AL101, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AL101Biological
Active dose of AL101
PlaceboOther
Saline solution administered as a single and multiple infusion as placebo.
| Study group | Role | What they receive |
|---|---|---|
| AL101 IV | Experimental | * Up to four single ascending doses (SAD IV cohorts)
* Multiple doses of AL101 administered IV (MD IV cohort) Receives: 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 Receives: Other: Placebo |
| AL101 SC | Experimental | * Single fixed dose levels of AL101 administered SC
* Multiple fixed dose of AL101 administered SC Receives: Biological: AL101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: either 57, 113, or 141 days, depending on the cohort
Secondary outcomes (3)
Pharmacokinetics (PK) of AL101
Serum and CSF concentration of AL101 at specified time points
Measured: either 57, 113, or 141 days, depending on the cohort
Maximum plasma concentration (Cmax) for AL101
Evaluate Cmax for serum and CSF concentration of AL101 at specified time points
Measured: either 57, 113, or 141 days, depending on the cohort
Area under the curve concentration (AUC) for AL101
Evaluate AUC for serum and CSF concentration of AL101 at specified time points
Measured: either 57, 113, or 141 days, depending on the cohort
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start14 Dec 2019
- Primary completion9 Jun 2022
- Study completion9 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alector Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jorge Kusnir, Principal investigator, Bioclinica ResearchMaria Bermudez, Principal investigator, Quotient Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04111666
- Sponsor's protocol ID
- AL101-1
- Status last verified
- May 2022
- First submitted
- 30 Sep 2019
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40713730
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study in Healthy Volunteers to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Bioavailability of IV and SC AL101
- ClinicalTrials.gov ID
- NCT04111666
- Acronym / sponsor ID
- AL101-1
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Alector Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Dec 2019 (actual)
- Primary completion
- 9 Jun 2022 (actual)
- Study completion
- 9 Jun 2022 (actual)
- First posted
- 1 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A first in human phase 1 study in healthy volunteers to assess AL101 safety, tolerability, bioavailability, pharmacokinetics, and pharmacodynamics
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AL101 IV | Experimental | Biological: AL101* Up to four single ascending doses (SAD IV cohorts) * Multiple doses of AL101 administered IV (MD IV cohort) |
| Saline Solution | Placebo comparator | Other: PlaceboSaline 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 |
| AL101 SC | Experimental | Biological: AL101* Single fixed dose levels of AL101 administered SC * Multiple fixed dose of AL101 administered SC |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AL101Active dose of AL101 | Biological | AL101 IV, AL101 SC |
| PlaceboSaline solution administered as a single and multiple infusion as placebo. | Other | Saline Solution |
Primary outcome
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.
3 secondary outcomes
Pharmacokinetics (PK) of AL101
Time frame: either 57, 113, or 141 days, depending on the cohort
Maximum plasma concentration (Cmax) for AL101
Time frame: either 57, 113, or 141 days, depending on the cohort
Area under the curve concentration (AUC) for AL101
Time frame: either 57, 113, or 141 days, depending on the cohort
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Derived from this study: PubMed 40713730Budda 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorge Kusnir principal investigator
Bioclinica Research
Maria Bermudez principal investigator
Quotient Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AL101 in people with Healthy, run by Alector Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04111666, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2022.