Multiple Sclerosis Clinical Trial
Official title:
A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled Safety, Tolerability, and Pharmacokinetic Study of Single Ascending Oral Doses of ARN-6039 in Healthy Adult Subjects.
This Phase 1 study intends to determine the safety and tolerability of ARN-6039 in healthy subjects.
To determine the safety and tolerability in healthy subjects, ARN-6039 will be dosed in a
single-center, randomized, double-blind, placebo-controlled, ascending dose study. Five
cohorts of 10 subjects will be dosed in ascending order, beginning with a single dose of 50
mg of ARN-6039. Subsequent cohorts will be administered single doses of 100 mg, 150 mg, 200
mg, or 300 mg. Safety, tolerability, and pharmacokinetics will be evaluated prior to each
dose escalation using the assessment of all available safety and pharmacokinetic data.
In Cohorts 1 through 4, subjects will receive a single dose of ARN-6039 or matching placebo
under fasted conditions. In Cohort 5, subjects will be administered a single dose of ARN-6039
or a single dose of matching placebo under fasted conditions in Period 1 and under fed
conditions in Period 2 with a minimum 5-day washout period between each dose.
To support the administration of ARN-6039 in humans, preclinical toxicology studies performed
in rats and dogs demonstrated tolerability exceeding the intended therapeutic dose. In
addition, the safety and efficacy of ARN-6039 has been demonstrated in model systems and is
anticipated to be well tolerated in humans. This study will be the first administration of
ARN-6039 in human subjects.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05528666 -
Risk Perception in Multiple Sclerosis
|
||
| Completed |
NCT03608527 -
Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis
|
N/A | |
| Recruiting |
NCT05532943 -
Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Multiple Sclerosis
|
Phase 1/Phase 2 | |
| Completed |
NCT02486640 -
Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With Betaferon
|
||
| Completed |
NCT01324232 -
Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis
|
Phase 2 | |
| Completed |
NCT04546698 -
5-HT7 Receptor Implication in Inflammatory Mechanisms in Multiple Sclerosis
|
||
| Active, not recruiting |
NCT04380220 -
Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis
|
||
| Completed |
NCT02835677 -
Integrating Caregiver Support Into MS Care
|
N/A | |
| Completed |
NCT03686826 -
Feasibility and Reliability of Multimodal Evoked Potentials
|
||
| Recruiting |
NCT05964829 -
Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis
|
N/A | |
| Withdrawn |
NCT06021561 -
Orofacial Pain in Multiple Sclerosis
|
||
| Completed |
NCT03653585 -
Cortical Lesions in Patients With Multiple Sclerosis
|
||
| Recruiting |
NCT04798651 -
Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis
|
N/A | |
| Active, not recruiting |
NCT05054140 -
Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis
|
Phase 2 | |
| Completed |
NCT05447143 -
Effect of Home Exercise Program on Various Parameters in Patients With Multiple Sclerosis
|
N/A | |
| Recruiting |
NCT06195644 -
Effect of Galvanic Vestibular Stimulation on Cortical Excitability and Hand Dexterity in Multiple Sclerosis Patients
|
Phase 1 | |
| Completed |
NCT04147052 -
iSLEEPms: An Internet-Delivered Intervention for Sleep Disturbance in Multiple Sclerosis
|
N/A | |
| Completed |
NCT03591809 -
Combined Exercise Training in Patients With Multiple Sclerosis
|
N/A | |
| Completed |
NCT03594357 -
Cognitive Functions in Patients With Multiple Sclerosis
|
||
| Completed |
NCT03269175 -
BENEFIT 15 Long-term Follow-up Study of the BENEFIT and BENEFIT Follow-up Studies
|
Phase 4 |