Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Determine the Safety, Tolerability and Pharmacokinetics of UV-4B Solution Administered Orally in Healthy Subjects
Phase: PHASE1
Conditions: Viral Infection
Sponsor: Emergent BioSolutions

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DMID Protocol 15-0062 
 
 
Emergent BioSolutions
Confidential and Proprietary
Page 34 of 151
Version 4.0
10 January 2017
Dose escalation will proceed as shown in Table 2 below.  

DMID Protocol 15-0062 
 
 
Emergent BioSolutions
Confidential and Proprietary
Page 35 of 151
Version 4.0
10 January 2017
Table 2: 
Proposed Dose Escalation
Cohort
Proposed Dose Escalation Scheme
Dose
(mg) TID
1
Starting dose
30
SMC and FDA review of Safety and PK Data
2
Increase 2.5x
75
SMC and FDA review of Safety and PK Data
3
Increase 2x
150
SMC and FDA review of all Safety  and PK Data and Protocol Amendment
4
TBD
TBD
5
TBD
TBD

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