Study to Evaluate Safety and PK of a Single IM Dose of G03-52-01 vs Placebo in Adult Subjects
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Healthy
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: dose escalation trial of three dose cohorts of 10 subjects (A: 10mg, B: 25mg, and C: 50mgMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: randomized, double-blind, placebo-controlledPrimary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 45 years
- Gender
- Both males and females
Description
A Phase 1, randomized, double-blind, placebo-controlled dose escalation trial of three dose cohorts of 10 subjects (A: 10mg, B: 25mg, and C: 50mg). Dose escalation will not occur until safety data through Day 8 is reviewed by the Safety Review Committee (SRC). The study will consist of a twenty-eigh...
A Phase 1, randomized, double-blind, placebo-controlled dose escalation trial of three dose cohorts of 10 subjects (A: 10mg, B: 25mg, and C: 50mg). Dose escalation will not occur until safety data through Day 8 is reviewed by the Safety Review Committee (SRC). The study will consist of a twenty-eight day screening period and 8-hour clinic stay. Follow-up visits will occur on Days (±3 days) 4, 8, 15, 30, 45, 60, 90, and 120 for all cohorts. Pharmacokinetics (PK) and anti-drug antibodies will be tested.
Tracking Information
- NCT #
- NCT04171115
- Collaborators
- United States Department of Defense
- Investigators
- Principal Investigator: Cassandra Key, MD ICON Early Phase Services, LLC
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