NCT05882695CompletedPhase 1
Study of SPG302 in Healthy Volunteers and ALS Participants
A Phase 1/2a, Randomized, Double Blind, Placebo Controlled, Single and Multiple Dose Escalation Study in Healthy Volunteers and an Expansion Cohort in Adult Participants With Amyotrophic Lateral Sclerosis (ALS) to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPG302
Source: ClinicalTrials.gov · Last updated 29 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The first-in-human Phase 1 study described herein will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SPG302 in healthy volunteers and ALS participants
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 88 (actual)
- First submitted
- 22 May 2023
- Start date
- 3 Jul 2023
- Primary completion date
- 27 Jun 2025
- Lead sponsor
- Spinogenix
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT05882695
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 88
- From 3 Jul 2023 to the primary completion date, 27 Jun 2025
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Surgery, bone fracture, or major musculoskeletal injury in the past 3 months
- Prescriptions, over-the-counter, or herbal medication within 7 days
- Vaccines within 14 days
- Other investigational products within 30 days
- Otherwise unfit, on metabolic-altering lifestyle/diet, positive urine drug screen or intake of alcohol or caffeine-containing products
- ALS Cohort Inclusion Criteria:
- Vaccines within 14 days
- Other investigational products within 30 days
Other illness
- 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
- History of suicidal behavior or suicidal ideation
- HIV, hepatitis B and hepatitis C positive
- QTcF \>450ms, cardiac arrhythmia, or clinically significant abnormal ECG
- 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
- Neurodegenerative disease
- HIV, hepatitis B and hepatitis C positive
- QTcF \>450ms, cardiac arrhythmia, or clinically significant abnormal ECG
Age
- Age 18-80
Other
- Active cigarette smokers and users of nicotine-containing products
- SBP \>140 or \<90
- DBP \>90 or \<40
- HR \<40 or \>100
- Blood donation within 30 days
- Plasma donation within 7 days
- Pregnant or breastfeeding
- 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:
- Active cigarette smokers and users of nicotine-containing products
- External respiratory support or supplemental oxygen requirement
- SBP \>140 or \<90
- DBP \>90 or \<40
- HR \<40 or \>100
- Blood donation within 30 days
- Plasma donation within 7 days
- Pregnant or breastfeeding
- Otherwise unfit
Who the study is looking for
- 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
Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Flinders Medical center Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
| Royal Brisbane and Women's Hospital Coordinator of this site? Confirm its status | Herston | Australia | Unknown status |
| Nucleus Melbourne (healthy volunteers) Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Macquarie University Coordinator of this site? Confirm its status | North Ryde | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.