A Study in Healthy Subjects to Assess the Safety and Tolerability of a 120-hour Continuous Infusion of M6229
NCT07285603 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2025-12-16
Summary
This is a Phase I, single-center, randomized, single-blind, placebo-controlled study in healthy subjects assessing the safety, tolerability and pharmacokinetic profile of three different dose levels of M6229 when administered continuously for 120 hours.
Conditions
- Healthy Subjects
Interventions
- DRUG
-
M6229
Continuous 120-hour intravenous infusion of M6229
- DRUG
-
Continuous 120-hour intravenous infusion of placebo (saline)
Sponsors & Collaborators
-
Matisse Pharmaceuticals
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- SINGLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-11-21
- Primary Completion
- 2025-06-18
- Completion
- 2025-06-18
Countries
- Germany
Study Locations
More Related Trials
-
Retrospective Study on the Safety and Therapeutic/Improvement Effects of Intravenous Administration of SHED-CM for ALS (SHED-CAH2023)
NCT06608719 ·Status: COMPLETED
-
Phase1 First in Human Ascending Dose Study to Evaluate the Safety and Tolerability of FC-12738 in Health Adults
NCT05978908 ·Status: COMPLETED ·Phase: PHASE1
-
A Multicenter Phase I/II Clinical Trial to Evaluate Safety of Mesenchymal Stem Cell in Patients With Amyotrophic Sclerosis Lateral
NCT02290886 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Trial to Investigate Safety and Pharmacokinetics of GRT6019, Including Food Effect, in Healthy Male Participants
NCT07317063 ·Status: COMPLETED ·Phase: PHASE1
-
The Safety, Tolerability and Preliminary Efficacy of Derived Motor Neuron Progenitor Cells (XS228CN) in Subjects With Amyotrophic Lateral Sclerosis
NCT07118319 ·Status: RECRUITING ·Phase: PHASE1
-
A Study to Investigate the Safety and Pharmacodynamics of a Single Intrathecal Injection (IT) of INS1202 in Participants With Amyotrophic Lateral Sclerosis (ALS)
NCT07290062 ·Status: RECRUITING ·Phase: PHASE1
-
Intrathecal Autologous Adipose-derived Mesenchymal Stromal Cells for Amyotrophic Lateral Sclerosis (ALS)
NCT03268603 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Dose-escalation Safety Trial for Intrathecal Autologous Mesenchymal Stem Cell Therapy in Amyotrophic Lateral Sclerosis
NCT01609283 ·Status: COMPLETED ·Phase: PHASE1
-
Clinical Trial on the Use of Cell Therapy in the Treatment of Patients With Amyotrophic Lateral Sclerosis
NCT04849065 ·Status: UNKNOWN ·Phase: PHASE2
-
Safety and Biomarker Study of EPI-589 in Participants With Amyotrophic Lateral Sclerosis (ALS)
NCT02460679 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS) Who Met Severity Classification III
NCT00415519 ·Status: COMPLETED ·Phase: PHASE3
-
A First in Human Study of ORT247 in Healthy Volunteers
NCT06769620 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 1/2 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMN 351 in Participants With Duchenne Muscular Dystrophy
NCT06280209 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
An Extension Trial to Test if TEV-56286 is Effective in Relieving Multiple System Atrophy
NCT07197866 ·Status: RECRUITING ·Phase: PHASE2
-
Mesenchymal Stem Cells for Treatment of Amyotrophic Lateral Sclerosis (ALS)
NCT01142856 ·Status: COMPLETED ·Phase: PHASE1
-
AMX0114 in Adult Participants With Amyotrophic Lateral Sclerosis
NCT06665165 ·Status: RECRUITING ·Phase: PHASE1
-
Evaluate the Safety and Efficacy of EN001 in Patients With Charcot-Marie-Tooth Disease Type 1A
NCT06328712 ·Status: COMPLETED ·Phase: PHASE1
-
Repeated Mesenchymal Stem Cell Injections in ALS
NCT04821479 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study of LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis
NCT07100119 ·Status: RECRUITING ·Phase: PHASE1
-
Clinical Outcome Measures in Myotonic Dystrophy Type 2
NCT03603171 ·Status: COMPLETED
-
Randomized Double-Blind Placebo-Controlled Adaptive Design Trial Of Intrathecally Administered Autologous Mesenchymal Stem Cells In Multiple System Atrophy
NCT05167721 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Exploring the Physiologic, Pharmacodynamic, and Clinical Responses of Skeletal Muscle in Patients With Spinal Muscular Atrophy Treated With SMN-Directed Therapies
NCT06532474 ·Status: RECRUITING
-
Effect and Safety MABs Administration m.3243A>G Mutation Carriers
NCT05962333 ·Status: RECRUITING ·Phase: PHASE2
-
Expanded Controlled Study of Safety and Efficacy of MCI-186 in Patients With Amyotrophic Lateral Sclerosis (ALS)
NCT00424463 ·Status: COMPLETED ·Phase: PHASE3
-
Exploring Nasal Drop Therapy With Small Extracellular Vesicles for ALS
NCT06598202 ·Status: RECRUITING ·Phase: PHASE1/PHASE2