SPG302 for ALS
Recruiting at 5 trial locations
Pq
OM
OM
Pq
Overseen ByPublic queries for healthy volunteers
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: Spinogenix
Trial Summary
What is the purpose of this trial?
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
Research Team
OM
Ofer M Gonen, MD
Principal Investigator
Nucleus Network (for healthy volunteers)
DS
David Schultz (ALS site), MD
Principal Investigator
Finders Medical Center (ALS)
RH
Robert Henderson (ALS site), MD
Principal Investigator
Royal Brisbane Hospital (ALS)
DR
Dominic Rowe
Principal Investigator
Macquarie Hospital
Eligibility Criteria
This trial is for healthy adults aged 18-55 with no significant medical history, normal lab values, and a BMI between 18-32. Participants must use contraception and agree to the study's terms. It also includes those diagnosed with ALS.Inclusion Criteria
BMI 18-32 (inclusive)
Clinical laboratory values within normal range or < 1.2 times ULN
Able and willing to provide written informed consent
See 3 more
Exclusion Criteria
HIV, hepatitis B and hepatitis C positive
Other investigational products within 30 days
Pregnant or breastfeeding
See 17 more
Treatment Details
Interventions
- SPG302 (Other)
Trial OverviewThe study tests SPG302 against a placebo to assess its safety and effects in the body (pharmacokinetics) and how it influences disease processes (pharmacodynamics) in both healthy individuals and ALS patients.
Participant Groups
7Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental Part 3: Open Label Extension - Active SPG302 administered to participants with ALSExperimental Treatment1 Intervention
Participants with ALS will be randomized to receive SPG302 or placebo at a 3:1 ratio. Study intervention will be administered QD over 28 days for up to 3 cycles in the USA and up to 12 cycles in Australia. A follow-up safety visit will be conducted 30 days after last dose (±7 days).
Group II: Experimental Part 3: Active SPG302 to be administered to participants with ALSExperimental Treatment1 Intervention
Participants with ALS will be randomized to receive SPG302 or placebo at a 3:1 ratio. Study intervention will be administered QD over 28 days. A follow-up safety visit will be conducted 30 days after last dose (±7 days). Participants who complete Part 3 may be offered to participate in an open-label extension.
Group III: Experimental Part 2: Active SPG302 to be administered to healthy volunteers (MAD)Experimental Treatment1 Intervention
8 participants will be randomized in a 3:1 ratio to active or placebo. Participants will receive study intervention QD over 5 days and will be discharged on Day 6. A follow-up safety visit will be conducted on Day 12 (±3 days).
Group IV: Experimental Part 1: Active SPG302 to be administered to healthy volunteers (SAD)Experimental Treatment1 Intervention
8 participants will be randomized in a 3:1 ratio to active or placebo. Study intervention will be administered orally once. Randomization to each SAD cohort will be done in a staggered manner; initially 2 sentinel participants (1 active and 1 placebo) will be randomized and dosed and after a safety evaluation period after the dose without clinically significant adverse events (AEs) and investigator approval, then, 6 additional participants will be randomized and dosed (5 active and 1 placebo) at the discretion of the Investigator according to the randomization schedule
Group V: Placebo Comparator Part 2: Placebo comparator to be administered to healthy volunteers (MAD)Placebo Group1 Intervention
8 participants will be randomized in a 3:1 ratio to active or placebo. Participants will receive study intervention QD over 5 days and will be discharged on Day 6. A follow-up safety visit will be conducted on Day 12 (±3 days).
Group VI: Placebo Comparator Part 1: Placebo comparator to be administered to healthy volunteers (SAD)Placebo Group1 Intervention
8 participants will be randomized in a 3:1 ratio to active or placebo. Study intervention will be administered orally once. Randomization to each SAD cohort will be done in a staggered manner; initially 2 sentinel participants (1 active and 1 placebo) will be randomized and dosed and after a safety evaluation period after the dose without clinically significant adverse events (AEs) and investigator approval, then, 6 additional participants will be randomized and dosed (5 active and 1 placebo) at the discretion of the Investigator according to the randomization schedule
Group VII: Placebo Comparator Part 3: Placebo comparator to be administered to participants with ALSPlacebo Group1 Intervention
Participants with ALS will be randomized to receive SPG302 or placebo at a 3:1 ratio. Study intervention will be administered QD over 28 days. A follow-up safety visit will be conducted 30 days after last dose (±7 days). Participants who complete Part 3 may be offered to participate in an open-label extension.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Spinogenix
Lead Sponsor
Trials
6
Recruited
220+
Novotech (Australia) Pty Limited
Industry Sponsor
Trials
76
Recruited
7,800+
Dr. John Moller
Novotech (Australia) Pty Limited
Chief Executive Officer
MD and MBA from the University of Oxford
Dr. Judith Ng-Cashin
Novotech (Australia) Pty Limited
Chief Medical Officer since 2023
MD