Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPG302 in Healthy Volunteers and ALS Participants
Sponsored by Spinogenix
About this trial
Last updated 2 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Trial Timing
Ended 5 months ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
- Age 18-55
- Must be in good health with no significant medical history
- Clinical laboratory values within normal range
- 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 or intake of alcohol or caffeine-containing products ALS Cohort Inclusion Criteria:
- Age 18-80
- ALS
- FVC>80%
- ALSFRS-R >=12 points
- 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
- 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
- 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