A Single Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of RBD1016
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Healthy Volunteers
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Sequential AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 45 years
- Gender
- Both males and females
Description
It is a randomized, double-blind, placebo-controlled, single dose-escalation, phase Ia study. The study will enroll 40 healthy subjects, including 5 dose escalation cohorts for dose escalation with 0.3 mg/kg body weight as the starting dose. After a single-dose injection, there will be a 4-week safe...
It is a randomized, double-blind, placebo-controlled, single dose-escalation, phase Ia study. The study will enroll 40 healthy subjects, including 5 dose escalation cohorts for dose escalation with 0.3 mg/kg body weight as the starting dose. After a single-dose injection, there will be a 4-week safety assessment and monitoring phase (Days 1-29). Blood samples for PK analysis will be collected within 60 minutes before dosing, and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h after dosing, respectively. According to the previous PK results, the subsequent PK blood collection points can be adjusted. Total urine samples will be collected once before dosing and in each of 2 time periods after dosing: 0~8 h and 8~24 h. The total urine output will be recorded, and some urine samples will be collected in each time period to analyze and detect the urine drug concentration. Subjects will undergo safety follow-up from Day 29 to Day 85.
Tracking Information
- NCT #
- NCT04685564
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Charlotte Dr. Lemech Scientia Clinical Research Ltd.
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