A Study of TAK-510 in Healthy Adults
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Healthy Participants
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Sequential AssignmentMasking: Double (Participant, Investigator)Primary Purpose: Other
Participation Requirements
- Age
- Between 18 years and 55 years
- Gender
- Both males and females
Description
The drug being tested in this study is called TAK-510. The study will look at the safety, tolerability, and PK of TAK-510 in healthy participants. The study will enroll up to approximately 160 healthy participants. Participants in each cohort will be randomized to receive treatment with TAK-510 or m...
The drug being tested in this study is called TAK-510. The study will look at the safety, tolerability, and PK of TAK-510 in healthy participants. The study will enroll up to approximately 160 healthy participants. Participants in each cohort will be randomized to receive treatment with TAK-510 or matching placebo which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need). The study consists of 3 parts and up to 20 cohorts as mentioned below. TAK-510, Part 1: SRD design to assess the safety, immunogenicity, tolerability, and PK of TAK-510 TAK-510, Part 2: MRD design to assess the safety, immunogenicity, tolerability, and PK of TAK-510 TAK-510, Part 3: Dose titration and redosing design to assess the safety, immunogenicity, tolerability, and PK of TAK-510 This multi-center trial will be conducted in the United States. The overall duration of the study is approximately 57 days. Participants will be followed up for 7 days after the last dose of study drug for a follow-up assessment.
Tracking Information
- NCT #
- NCT04731922
- Collaborators
- Not Provided
- Investigators
- Study Director: Medical Director Takeda