Prosetin for ALS (PRO-101 Trial)
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: ProJenX
Trial Summary
What is the purpose of this trial?This trial tests a new drug called prosetin on healthy adults to ensure it is safe and understand how the body processes it.
Eligibility Criteria
Adults aged 18-65 with a BMI of 18.0 to 32.0, in good health as determined by medical exams, and willing to use contraception can join this trial. It's for healthy volunteers and those with ALS.Inclusion Criteria
I am between 18 and 65 years old.
Participant Groups
The study is testing the safety of Prosetin, a potential treatment for ALS. Participants will receive either Prosetin or a placebo to compare effects.
7Treatment groups
Experimental Treatment
Placebo Group
Group I: Part D - open-label administration of prosetin in participants with ALSExperimental Treatment1 Intervention
Participants will be administered a once-daily dose of prosetin for up to 52 weeks.
Group II: Part C - multiple ascending doses of prosetin in participants with ALSExperimental Treatment1 Intervention
Participants will be administered a once-daily dose of prosetin at multiple ascending dose levels for 14 days.
Group III: Part B - multiple ascending doses of prosetinExperimental Treatment1 Intervention
Healthy volunteers were administered a once-daily dose of prosetin at 0.06 or 0.10 mg/kg for 14 days.
Group IV: Part A - single ascending doses of prosetinExperimental Treatment1 Intervention
Healthy volunteers were administered a single dose of prosetin oral solution at 0.03, 0.06, 0.12, or 0.24 mg/kg.
Group V: Part A - single dose of placeboPlacebo Group1 Intervention
Healthy volunteers were administered a single dose of prosetin-matched placebo oral solution.
Group VI: Part B - multiple doses of placeboPlacebo Group1 Intervention
Healthy volunteers were administered a once-daily dose of prosetin-matched placebo for 14 days.
Group VII: Part C - multiple doses of placebo in participants with ALSPlacebo Group1 Intervention
Participants are administered a once-daily dose of prosetin-matched placebo for 14 days.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Massachusetts General HospitalBoston, MA
The Neuro - Montréal Neurological Institute-HospitalMontréal, Canada
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Who is running the clinical trial?
ProJenXLead Sponsor
Worldwide Clinical TrialsCollaborator