Recruitment

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