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NI112 for ALS

Not yet recruiting at 2 trial locations
PN
Overseen ByPrashant Nagpal, Ph.D.
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Sachi Bioworks Inc.

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a first-in-human study of NI112, an investigational medicine given as an injection under the skin, in adults with amyotrophic lateral sclerosis (ALS). The purpose of the study is to find out how safe NI112 is, how well it is tolerated, and how the body handles it after a single dose. Up to 40 adults with ALS will take part at up to three study centers in the United States. Participants will be assigned by chance to receive either a single dose of NI112 or a single dose of placebo (sterile salt water). The study tests up to seven dose levels, one after another, beginning with the lowest dose. A Safety Review Board reviews the safety information from each group of participants before the next, higher dose is given to a new group. Each participant stays in the hospital for 24 hours after the injection for safety monitoring and blood sampling, and returns for follow-up visits on Day 8 and Day 28. The study also measures the amount of NI112 in blood and in spinal fluid.

Who Is on the Research Team?

NP

Nathan P. Staff, M.D. Ph.D.

Principal Investigator

Mayo Clinic Rochester, Rochester, MN

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with ALS (also known as motor neuron disease). Participants must be able to visit the study center and meet basic health requirements. People with other serious medical conditions or who can't safely participate may not be eligible.

Inclusion Criteria

I have muscle weakness and a confirmed ALS diagnosis by standard criteria.
Forced vital capacity ≥ 50% of predicted, adjusted for sex, age, height and sitting position. Subjects with a stable forced vital capacity of 45 to 49% with no more than 5% decline over 6 months may be eligible at the Investigator's discretion.
Sexually active females of childbearing potential and non-sterile males must agree to use effective contraception during the study and for 90 days after the final dose. Males, including those who have had a vasectomy, with a pregnant partner must use a condom from the first dose and for 90 days after, and must not donate sperm for 90 days after the final dose.
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Exclusion Criteria

I will need blood thinners around the time of my lumbar puncture.
I have a tracheostomy tube in my neck.
Presence of an implanted cerebrospinal fluid shunt or central nervous system catheter.
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What Are the Treatments Tested in This Trial?

Interventions

  • NI112

Trial Overview

The study tests a new medicine called NI112, given as a single injection under the skin, compared to a placebo (salt water). Different dose levels are tested in small groups of participants to check safety and how the body processes the drug.

How Is the Trial Designed?

8

Treatment groups

Experimental Treatment

Placebo Group

Group I: NI112 80 mgExperimental Treatment1 Intervention
Group II: NI112 5 mgExperimental Treatment1 Intervention
Group III: NI112 40 mgExperimental Treatment1 Intervention
Group IV: NI112 20 mgExperimental Treatment1 Intervention
Group V: NI112 2.5 mgExperimental Treatment1 Intervention
Group VI: NI112 120 mgExperimental Treatment1 Intervention
Group VII: NI112 10 mgExperimental Treatment1 Intervention
Group VIII: PlaceboPlacebo Group1 Intervention

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Who Is Running the Clinical Trial?

Sachi Bioworks Inc.

Lead Sponsor

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