| Trial registration number
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NCT04711187 |
Full text link
Last imported at : Jan. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04711187
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First author
Last imported at : Jan. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Atea Pharmaceuticals, Inc.
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Contact
Last imported at : Jan. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Not reported
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Registration date
Last imported at : Jan. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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2021-01-15
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Recruitment status
Last imported at : Jan. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Completed
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Study design
Last imported at : Jan. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : Jan. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : Jan. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : Jan. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Blind label
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Center
Last imported at : Jan. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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single-center
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Study aim
Last imported at : Jan. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Prevention
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Inclusion criteria
Last imported at : Jan. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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inclusion criteria:
- must agree to use two methods of birth control from screening through 90 days after
administration of the last dose of study drug
- females must have a negative pregnancy test at screening and prior to dosing
- minimum body weight of 50 kg and body mass index (bmi) of 18-32 kg/m2
- willing to comply with the study requirements and to provide written informed consent
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Exclusion criteria
Last imported at : Jan. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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- pregnant or breastfeeding
- infected with hepatitis b virus, hepatitis c virus, hiv or covid-19
- abuse of alcohol or drugs
- use of other investigational drugs within 28 days of dosing
- other clinically significant medical conditions or laboratory abnormalities
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Number of arms
Last imported at : Jan. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : Jan. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Atea Pharmaceuticals, Inc.
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Inclusion age min
Last imported at : Jan. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : Jan. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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65
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Countries
Last imported at : Jan. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Canada
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Type of patients
Last imported at : Jan. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Healthy volunteers
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Severity scale
Last imported at : Jan. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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N/A
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Total sample size
Last imported at : Jan. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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20
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primary outcome
Last imported at : Jan. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Proportions (active vs. placebo) of subjects experiencing treatment-emergent adverse events.
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Notes
Last imported at : Jan. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : Jan. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Phase 1
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Arms
Last imported at : Jan. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "", "treatment_id": 134, "treatment_name": "At-527", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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