Study of AT-587 in Healthy Subjects
ConditionHepatitis E
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAtea Pharmaceuticals, Inc.
About this trial
This study will assess the safety, tolerability and pharmacokinetics (PK) of AT-587 in healthy subjects
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Body mass index (BMI) of 18-29 kg/m2
Must agree to use protocol-specified methods of contraception
Negative pregnancy test
Willing to comply with the study requirements and to provide written informed consent
Disqualifiers
Pregnant or breastfeeding
Abuse of alcohol or drugs
Use of other investigational drugs within 30 days of dosing
Other clinically significant medical conditions
Trial design
Design model
Sequential
Treatments tested in this trial
AT-587
DrugParallel Assignment
Placebo
Other interventionParallel Assignment
Treatment groups
62 Participants
are divided into 14 treatment groups14
Treatment groupsSee each treatment group below.
Group A: AT-587 Dose 1 (Day 1)Experimental treatment 1 intervention
Group B: Placebo -Dose 1 (Day 1)Placebo comparator 1 intervention
Group C: AT-587 Dose 2 (Day 1 and Day 7)Experimental treatment 1 intervention
Group D: Placebo-Dose 2 (Day 1 and Day 7)Placebo comparator 1 intervention
Group E: AT-587 Dose 3 - (Day 1)Experimental treatment 1 intervention
Group F: Placebo - Dose 3 - (Day 1)Placebo comparator 1 intervention
Group G: AT-587 Dose 4 - (Day 1)Experimental treatment 1 intervention
Group H: Placebo - Dose 4- (Day 1)Placebo comparator 1 intervention
Group I: AT-587 - Dose 5 (Day 1-7)Experimental treatment 1 intervention
Group J: Placebo- Dose 5 (QD) (Day 1-7)Placebo comparator 1 intervention
Group K: AT-587 - Dose 6 split (BID) (Day 1-7)Experimental treatment 1 intervention
Group L: Placebo - Dose 6 (BID) (Day 1-7)Placebo comparator 1 intervention
Group M: AT-587 - Dose 7 (QD) or split (BID) daily (Day 1-7)Experimental treatment 1 intervention
Group N: Placebo - Dose 7 (QD) or split (BID) (Day 1-7)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Proportions (active vs. Placebo) of subjects experiencing treatment-emergent adverse events
Time frame
Day 1 up to Day 13Secondary outcomes
1
Pharmacokinetics (PK) of AT-587 (Cmax)
Maximum plasma concentration (Cmax)
Time frame
Day 1 up to Day 132
Pharmacokinetics (PK) of AT-587 (AUC)
Area under the concentration-time curve (AUC)
Time frame
Day 1 up to Day 13Sponsors and contacts
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Source ClinicalTrials.gov