Trial · NCT07906665

A Study of Single Ascending Doses of NI112 in Adults With Amyotrophic Lateral Sclerosis (ALS)

NCT07906665, Phase 1, Not yet recruiting, Sachi Bioworks Inc.

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of Single Ascending Doses of NI112 in Adults With Amyotrophic Lateral Sclerosis (ALS). Trials, record NCT07906665. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07906665

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of Single Ascending Doses of NI112 in Adults With Amyotrophic Lateral Sclerosis (ALS)
NCT number: NCT07906665
Status: Not yet recruiting
Phases: Phase 1
Enrollment: 40 participants, estimated
Lead sponsor: Sachi Bioworks Inc.
Conditions: Amyotrophic Lateral Sclerosis (ALS)
Interventions: NI112, Placebo
First posted: 2026-10-30
Last updated: 2026-10-30

Source ClinicalTrials.gov

Registered outcomes21

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With incidence and severity of treatment-emergent adverse events	Day 1 through Day 28	Number and percentage of participants with treatment-emergent adverse events, graded by severity according to NCI CTCAE version 5.0.
Primary	Number of Participants With incidence and severity of treatment-emergent serious adverse events	Day 1 through Day 28	Number and percentage of participants with treatment-emergent serious adverse events, graded by severity according to NCI CTCAE version 5.0.
Primary	Number of Participants With Treatment-Emergent Clinically Significant Blood Pressure Abnormalities	Day 1 through Day 28	Systolic and diastolic blood pressure, in mmHg, measured at screening, predose on Day 1, within one hour before the 2-hour and 4-hour postdose pharmacokinetic blood draws on Day 1, at 24 hours postdose on Day 2, on Day 8 and on Day 28. A value or finding is counted as clinically significant where it is newly present after dosing and the Investigator records it as clinically significant, applying the protocol definition: a finding that meets serious adverse event criteria, necessitates specific corrective therapy, or is deemed clinically significant by the Investigator. The single reported value is the NUMBER OF PARTICIPANTS with at least one such finding, by treatment arm.
Primary	Number of Participants With Treatment-Emergent Clinically Significant Pulse Rate Abnormalities	Day 1 through Day 28	Pulse rate, in beats per minute, measured at screening, predose on Day 1, within one hour before the 2-hour and 4-hour postdose pharmacokinetic blood draws on Day 1, at 24 hours postdose on Day 2, on Day 8 and on Day 28. A value or finding is counted as clinically significant where it is newly present after dosing and the Investigator records it as clinically significant, applying the protocol definition: a finding that meets serious adverse event criteria, necessitates specific corrective therapy, or is deemed clinically significant by the Investigator. The single reported value is the NUMBER OF PARTICIPANTS with at least one such finding, by treatment arm.
Primary	Number of Participants With Treatment-Emergent Clinically Significant Respiratory Rate Abnormalities	Day 1 through Day 28	Respiratory rate, in breaths per minute, measured at screening, predose on Day 1, within one hour before the 2-hour and 4-hour postdose pharmacokinetic blood draws on Day 1, at 24 hours postdose on Day 2, on Day 8 and on Day 28. A value or finding is counted as clinically significant where it is newly present after dosing and the Investigator records it as clinically significant, applying the protocol definition: a finding that meets serious adverse event criteria, necessitates specific corrective therapy, or is deemed clinically significant by the Investigator. The single reported value is the NUMBER OF PARTICIPANTS with at least one such finding, by treatment arm.
Primary	Number of Participants With Treatment-Emergent Clinically Significant Body Temperature Abnormalities	Day 1 through Day 28	Body temperature, in °C, measured at screening, predose on Day 1, within one hour before the 2-hour and 4-hour postdose pharmacokinetic blood draws on Day 1, at 24 hours postdose on Day 2, on Day 8 and on Day 28. A value or finding is counted as clinically significant where it is newly present after dosing and the Investigator records it as clinically significant, applying the protocol definition: a finding that meets serious adverse event criteria, necessitates specific corrective therapy, or is deemed clinically significant by the Investigator. The single reported value is the NUMBER OF PARTICIPANTS with at least one such finding, by treatment arm.
Primary	Number of Participants With Treatment-Emergent Clinically Significant Neurological Examination Findings	Day 1 through Day 8	A neurological examination is performed at screening, predose on Day 1, at 3 hours and 6 hours postdose on Day 1, at 24 hours postdose on Day 2, and on Day 8. A value or finding is counted as clinically significant where it is newly present after dosing and the Investigator records it as clinically significant, applying the protocol definition: a finding that meets serious adverse event criteria, necessitates specific corrective therapy, or is deemed clinically significant by the Investigator. The single reported value is the NUMBER OF PARTICIPANTS with at least one such finding, by treatment arm.
Primary	Number of Participants With Treatment-Emergent Clinically Significant Physical Examination Findings	Day 1 through Day 8	A physical examination is performed at screening and predose on Day 1. A limited physical examination is performed at 24 hours postdose on Day 2 and on Day 8, at the Investigator's discretion. A value or finding is counted as clinically significant where it is newly present after dosing and the Investigator records it as clinically significant, applying the protocol definition: a finding that meets serious adverse event criteria, necessitates specific corrective therapy, or is deemed clinically significant by the Investigator. The single reported value is the NUMBER OF PARTICIPANTS with at least one such finding, by treatment arm.
Primary	Number of Participants With Treatment-Emergent Clinically Significant 12-Lead Electrocardiogram Abnormalities, Including QT Interval Corrected by Fridericia's Formula (QTcF)	Day 1 through Day 28	Triplicate 12-lead electrocardiograms are recorded after the participant has rested supine for at least 10 minutes, at screening, predose on Day 1, within one hour before the 2-hour and 4-hour postdose pharmacokinetic blood draws on Day 1, at 24 hours postdose on Day 2, on Day 8 and on Day 28. The first recording is interpreted and the remaining two are checked for consistency and quality. The QT interval is corrected by Fridericia's formula and reported in milliseconds. A QTcF above 500 ms, or an increase from baseline above 60 ms, meets a protocol-defined dose-limiting toxicity criterion. A value or finding is counted as clinically significant where it is newly present after dosing and the Investigator records it as clinically significant, applying the protocol definition: a finding that meets serious adverse event criteria, necessitates specific corrective therapy, or is deemed clinically significant by the Investigator. The single reported value is the NUMBER OF PARTICIPANTS wit
Primary	Number of Participants With Treatment-Emergent Clinically Significant Hematology Abnormalities	Day 1 through Day 28	Hematology comprises a complete blood count with differential, platelet count and absolute neutrophil count, collected at screening, predose on Day 1, at 24 hours postdose on Day 2, on Day 8 and on Day 28, and analyzed by a designated central laboratory. Coagulation testing (platelet count, international normalized ratio, prothrombin time and activated partial thromboplastin time) is performed at screening only. A laboratory value is counted as clinically significant where, per the protocol, it meets serious adverse event criteria, necessitates specific corrective therapy, or is deemed clinically significant by the Investigator. The single reported value is the number of participants with at least one such value, by treatment arm.

1 to 10 of 21Source ClinicalTrials.gov

See all 21 registered outcomes

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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