Prosetin for ALS

(PRO-101 Trial)

Recruiting at 2 trial locations

Overseen By Ingela Danielsson, MD, PhD, MBA

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: ProJenX

Must be taking: Riluzole

Must not be taking: Investigational drugs

Disqualifiers: Dementia, Cancer, Seizures, others

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

72 Participants Needed

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.

Will I have to stop taking my current medications?

If you are taking riluzole or other standard ALS treatments, you must be on a stable dose for at least 30 days before the trial and continue it throughout the study. The protocol does not specify about other medications, so it's best to discuss with the trial team.

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

My BMI is between 18.0 and 32.0.

My overall health is good as confirmed by recent medical exams.

I agree to use birth control as required.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple ascending doses of prosetin or placebo for 14 days

2 weeks

Daily visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants with ALS may opt into continuation of treatment with prosetin for up to 52 weeks

52 weeks

Treatment Details

Interventions

• placebo
• prosetin

Trial Overview The study is testing the safety of Prosetin, a potential treatment for ALS. Participants will receive either Prosetin or a placebo to compare effects.

Participant Groups

Group I: Part D - open-label administration of prosetin in participants with ALS Experimental Treatment 1 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 ALS Experimental Treatment 1 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 prosetin Experimental Treatment 1 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 prosetin Experimental Treatment 1 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 placebo Placebo Group 1 Intervention

Healthy volunteers were administered a single dose of prosetin-matched placebo oral solution.

Group VI: Part B - multiple doses of placebo Placebo Group 1 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 ALS Placebo Group 1 Intervention

Participants are administered a once-daily dose of prosetin-matched placebo for 14 days.

Who Is Running the Clinical Trial?

ProJenX

Lead Sponsor

Trials

1

Recruited

70+

Congressionally Directed Medical Research Programs

Collaborator

Trials

59

Recruited

10,600+

Worldwide Clinical Trials

Collaborator

Trials

70

Recruited

15,800+