Study of SPG302 in Healthy Volunteers and ALS Participants

Inclusion Criteria:

• Age 18-55

• Must be in good health with no significant medical history

• Clinical laboratory values within normal range or < 1.2 times ULN

• BMI 18-32 (inclusive)

• Contraceptive use by men or women consistent with local regulations

• Able and willing to provide written informed consent

Exclusion Criteria:

• Any physical or psychological condition that prohibits study completion

• Known cardiac disease

• Active or history of malignancy in the past 5 years

• Serious infection within 1 month of screening

• Acute illness within 30 days of Day 1

• Surgery, bone fracture, or major musculoskeletal injury in the past 3 months

• History of suicidal behavior or suicidal ideation

• Active cigarette smokers and users of nicotine-containing products

• HIV, hepatitis B and hepatitis C positive

• SBP >140 or <90

• DBP >90 or <40

• HR <40 or >100

• QTcF >450ms, cardiac arrhythmia, or clinically significant abnormal ECG

• Prescriptions, over-the-counter, or herbal medication within 7 days

• Vaccines within 14 days

• Other investigational products within 30 days

• Blood donation within 30 days

• Plasma donation within 7 days

• Pregnant or breastfeeding

• Otherwise unfit, on metabolic-altering lifestyle/diet, positive urine drug screen orintake of alcohol or caffeine-containing products

ALS Cohort Inclusion Criteria:

• Age 18-80

• ALS TRICALS risk score

• Stable dose of standard of care treatment

• Contraception use by men or women consistent with local regulations

• Able and willing to provide written informed consent

ALS Cohort Exclusion Criteria:

• Underlying physical or psychological condition prohibiting study completion

• Known cardiac disease

• Active or history of malignancy in the past 5 years

• Serious infection within 1 month of screening

• Acute illness within 30 days of Day 1

• History of suicidal behavior or suicidal ideation

• Active cigarette smokers and users of nicotine-containing products

• Neurodegenerative disease

• External respiratory support or supplemental oxygen requirement

• HIV, hepatitis B and hepatitis C positive

• SBP >140 or <90

• DBP >90 or <40

• HR <40 or >100

• QTcF >450ms, cardiac arrhythmia, or clinically significant abnormal ECG

• Vaccines within 14 days

• Other investigational products within 30 days

• Blood donation within 30 days

• Plasma donation within 7 days

• Pregnant or breastfeeding

• Otherwise unfit