CovidResearchTrials by Shray Alag

CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)

Placebo injectionWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (2)

Name (Synonyms) Correlation
drug2972 pulmonary ultrasound Wiki 1.00
drug206 Apramycin injection Wiki 1.00

Correlated MeSH Terms (3)

Name (Synonyms) Correlation
D055371 Acute Lung Injury NIH 0.10
D012127 Respiratory Distress Syndrome, Newborn NIH 0.10
D012128 Respiratory Distress Syndrome, Adult NIH 0.09

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 A Phase I, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Apramycin Administered Intravenously in Healthy Adults.

This is a first-in-human study to assess the safety, tolerability and pharmacokinetics of escalating single doses of apramycin. This trial will be conducted as a single ascending dose trial in up to 5 sequential dose cohorts (group-comparison). Each cohort will consist of 8 healthy subjects, 6 will receive apramycin and 2 placebo.

NCT04105205 Healthy Volunteers Drug: Apramycin injection Drug: Placebo injection

Primary Outcomes

Measure: Type and incidence of treatment-emergent adverse events (TEAEs) until 2 weeks after dosing.

Time: until 2 weeks after dosing

Measure: Type and incidence of TEAEs related to auditory and vestibular function tests.

Time: until 3 months after dosing

Description: Frequency is defined as number of subjects with clinically significant observations.

Measure: Number of subjects with clinically significant vital sign measurement blood pressure.

Time: until 2 weeks after dosing

Description: Frequency is defined as number of subjects with clinically significant observations.

Measure: Number of subjects with clinically significant vital sign measurement pulse rate.

Time: until 2 weeks after dosing

Description: Frequency is defined as number of subjects with clinically significant observations.

Measure: Number of subjects with clinically significant observation in physical examination.

Time: until 2 weeks after dosing

Description: Frequency is defined as number of subjects with clinically significant observations.

Measure: Number of subjects with clinically significant changes in clinical laboratory parameters.

Time: until 2 weeks after dosing

Description: ECG parameters include heart rate and PQ, QT, RS. Frequency is defined as number of subjects with clinically significant observations.

Measure: Number of subjects with clinically significant changes in ECG parameters.

Time: until 2 weeks after dosing

No related HPO nodes (Using clinical trials)