A Study of TAK-510 in Healthy Adults
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study of TAK-510 for people with symptoms of feeling sick (nausea) or being sick
      (vomiting).

      The main aims of the study are to check if healthy adults have side effects from TAK-510 and
      to check how much TAK-510 they can receive without getting side effects from it.

      The study will be in 3 parts. Participants will take part in only 1 of the 3 parts of the
      study.

      At the first visit, the study doctor will check if each person can take part. For those who
      can take part, they will be placed in 1 of many small groups. The 1st groups will join Part 1
      of the study, the 2nd groups will join Part 2 and the 3rd groups will join Part 3. They will
      receive an injection under the skin of either TAK-510 or placebo. In this study, a placebo
      will look like the TAK-510 injection but will not have any medicine in it.

      In Part 1, the 1st group of participants will receive 1 injection of either TAK-510 or
      placebo. Different participants within this group will receive lower to higher doses of
      TAK-510. The participants in this group will stay in the clinic for 4 days after their
      injection for some tests and check for any side effects from their treatment.

      In Part 2, the 2nd group of participants will receive an injection of either TAK-510 or
      placebo, once a day for 5 days. Different participants within this group will receive lower
      to higher doses of TAK-510. The participants in this group will stay in the clinic for 9 days
      after their 1st injection for some tests and check for any side effects from their treatment.

      In Part 3, the 3rd group of participants will visit the clinic 2 times. At the 1st visit,
      they will receive an injection either of TAK-510 or placebo, once a day for 7 days. Each
      participant in this group will receive lower to higher doses of TAK-510. They will stay in
      the clinic for 8 days after their 1st injection for some tests and check for any side effects
      from their treatment.

      At the 2nd clinic visit, each participant will receive 1 single injection of TAK-510 or
      placebo. This will happen 7 days after their last injection from the previous clinic visit.
      They will receive the same dose as their previous dose. They will stay in the clinic for 3
      days for some tests and check for any side effects from their treatment.

      After treatment, all participants in the study will return to the clinic for a weekly
      check-up visit for up to 3 weeks.
    

Detailed 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 224 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 28 cohorts as mentioned below.

        -  TAK-510, Part 1: Single rising dose (SRD) design to assess the safety, immunogenicity,
           tolerability, and PK of TAK-510

        -  TAK-510, Part 2: Multiple rising dose (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.
    

Intervention name(s): TAK-510; TAK-510 Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TAK-510 solution.; TAK-510 placebo-matching solution.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Drug Therapy