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

This is a first-in-human Phase 1 study designed to investigate the safety, tolerability, PK
and PD of intravenously administered AL001 in Healthy Volunteers and asymptomatic FTD-GRN
mutation carriers.

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. A

- 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