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NCT07906665

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

StatusNot Yet Recruiting
PhasePhase 1
Primary completion (estimated)
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Record History

All 1 version: 1 with changes below.

  1. Study First Submitted

Endpoints

Primary

Number of Participants With incidence and severity of treatment-emergent adverse events
Timeframe: Day 1 through Day 28
Number of Participants With incidence and severity of treatment-emergent serious adverse events
Timeframe: Day 1 through Day 28
Number of Participants With Treatment-Emergent Clinically Significant Blood Pressure Abnormalities
Timeframe: Day 1 through Day 28
Number of Participants With Treatment-Emergent Clinically Significant Pulse Rate Abnormalities
Timeframe: Day 1 through Day 28
Number of Participants With Treatment-Emergent Clinically Significant Respiratory Rate Abnormalities
Timeframe: Day 1 through Day 28
Number of Participants With Treatment-Emergent Clinically Significant Body Temperature Abnormalities
Timeframe: Day 1 through Day 28
Number of Participants With Treatment-Emergent Clinically Significant Neurological Examination Findings
Timeframe: Day 1 through Day 8
Number of Participants With Treatment-Emergent Clinically Significant Physical Examination Findings
Timeframe: Day 1 through Day 8
Number of Participants With Treatment-Emergent Clinically Significant 12-Lead Electrocardiogram Abnormalities, Including QT Interval Corrected by Fridericia's Formula (QTcF)
Timeframe: Day 1 through Day 28
Number of Participants With Treatment-Emergent Clinically Significant Hematology Abnormalities
Timeframe: Day 1 through Day 28
Number of Participants With Treatment-Emergent Clinically Significant Serum Chemistry Abnormalities
Timeframe: Day 1 through Day 28
Number of Participants With Treatment-Emergent Clinically Significant Urinalysis Abnormalities
Timeframe: Day 1 through Day 28
Number of Participants With discontinuations due to adverse events
Timeframe: Day 1 through Day 28
Maximum tolerated dose of single-dose NI112
Timeframe: From the first dose of the first cohort through the Day 28 visit of the last subject in the highest cohort evaluated, approximately 13 months

Secondary (7)

Peak Plasma Concentration (Cmax) of NI112
Time to Peak Plasma Concentration (Tmax) of NI112
Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC0-last) of NI112
Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of NI112
Apparent Terminal Elimination Half-Life (t1/2) of NI112 in Plasma
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Cerebrospinal fluid concentration of NI112
Cerebrospinal fluid to plasma partition coefficient

Arms and interventions

NI112 2.5 mgExperimental

Drug: NI112 Injection 2.5 mg

NI112 5 mgExperimental

Drug: NI112 Injection 5 mg

NI112 10 mgExperimental

Drug: NI112 Injection 10 mg

NI112 20 mgExperimental

Drug: NI112 Injection 20 mg

NI112 40 mgExperimental

Drug: NI112 Injection 40 mg

NI112 80 mgExperimental

Drug: NI112 Injection 80 mg

NI112 120 mgExperimental

Drug: NI112 Injection 120 mg

PlaceboPlacebo comparator

Drug: Placebo

Drugs: NI112, Placebo

Sites

3 sites in 1 country