A First in Human Study in Healthy Volunteers and in Participants With Frontotemporal Dementia With Granulin (GRN) Mutation

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03636204
• Date of registration: 12/07/2018
• Prospective Registration: Yes
• Primary sponsor: Alector Inc.
• Public title: A First in Human Study in Healthy Volunteers and in Participants With Frontotemporal Dementia With Granulin (GRN) Mutation
• Scientific title: A First in Human Phase 1 Study in Healthy Volunteers and in Participants With Frontotemporal Dementia (FTD) With Granulin Mutation
• Date of first enrolment: September 14, 2018
• Target sample size: 64
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03636204
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

Canada, Netherlands, United Kingdom, United States

Contacts

• Name: George Stoica
• Affiliation: Bioclinica Research

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Frontotemporal Dementia

Healthy

Intervention(s)

Other: Placebo

Biological: AL001

Primary Outcome(s)

Evaluation of safety and tolerability of AL001 measured by number of subjects with adverse events and Dose Limiting Adverse Event (DLAEs) [Time Frame: 85 days]

Secondary Outcome(s)

Pharmacokinetics (PK) of AL001 [Time Frame: 85 days]

Maximum plasma concentration (Cmax) for AL001 [Time Frame: 85 days]

Area under the curve concentration (AUC) for AL001 [Time Frame: 85 days]

Secondary ID(s)

AL001-1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors