SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03309605

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, Third Party Open, Multiple Dose Escalation, Single Center Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Subcutaneously Administered ELX-02 in Independent Consecutive Cohorts of Healthy Subjects

Phase 1 Multiple Ascending Dose Study in Normal Healthy Volunteers

NCT03309605 Genetic Disease Nonsense Mutation
MeSH: Genetic Diseases, Inborn

2 Interventions

Name: ELX-02

Description: ELX-02

Type: Drug

ELX-02

Name: Placebo

Description: Placebo

Type: Drug

Placebo Comparator Arm


Primary Outcomes

Description: Incidence and characteristics of adverse events occurring following single doses of ELX-02

Measure: Adverse Events

Time: 0-40 days

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There are 4 SNPs

SNPs


1 A1555G

4. Presence of mitochondrial mutations making subject susceptible to aminoglycoside toxicity (A1555G, C1494T, T1095C, A827G, 1-BP DEL, 961T, C INS). 5. Subjects with any history of ear disease or surgeries, persistent dizziness or persistent tinnitus. --- A1555G ---


2 A827G

4. Presence of mitochondrial mutations making subject susceptible to aminoglycoside toxicity (A1555G, C1494T, T1095C, A827G, 1-BP DEL, 961T, C INS). 5. Subjects with any history of ear disease or surgeries, persistent dizziness or persistent tinnitus. --- A1555G --- --- C1494T --- --- T1095C --- --- A827G ---


3 C1494T

4. Presence of mitochondrial mutations making subject susceptible to aminoglycoside toxicity (A1555G, C1494T, T1095C, A827G, 1-BP DEL, 961T, C INS). 5. Subjects with any history of ear disease or surgeries, persistent dizziness or persistent tinnitus. --- A1555G --- --- C1494T ---


4 T1095C

4. Presence of mitochondrial mutations making subject susceptible to aminoglycoside toxicity (A1555G, C1494T, T1095C, A827G, 1-BP DEL, 961T, C INS). 5. Subjects with any history of ear disease or surgeries, persistent dizziness or persistent tinnitus. --- A1555G --- --- C1494T --- --- T1095C ---



HPO Nodes