A Study of TAK-105 in Healthy Adults
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      It is hoped that in the future, TAK-105 will be used to help treat people with nausea and
      vomiting. The main aims of this study are as follows:

        -  To check for side effects from TAK-105 in healthy adults.

        -  To learn how much TAK-105 they can receive without getting side effects from it.

      Participants will receive either TAK-105 as TAK-105-a or TAK-105-b (depending upon the part
      they are enrolled in) or a placebo as an injection under the skin (sub-cutaneous injection).
      A placebo looks like TAK-105-a or TAK-105-b but will not have any medicine in it. Three times
      as many participants will receive TAK-105-a or TAK-105-b than placebo.

      The study will have 6 parts. Each part will have several small groups of participants, called
      cohorts. Participants will only be in 1 cohort in 1 part of the study.

      Part 1: Participants will check into the study clinic to receive a single dose of TAK-105-a
      or placebo and will stay in the clinic for about 10 days. Then, participants return to the
      clinic for follow-up visits up to about 60 days after the dose.

      Part 2: Participants will check into the study clinic to receive TAK-105-a or placebo once a
      week for 4 weeks, and will stay in the clinic for about 26 days. Then, participants return to
      the clinic for follow-up visits up to about 60 days after last dose.

      Part 3: Participants will check into the study clinic to receive 2, 3 or 4 weekly doses of
      TAK-105-a or placebo. Their clinic stay will be for 10 to 24 days depending which cohort they
      are in. Then, participants return to the clinic for follow-up visits up to about 28 days
      after last dose.

      Part 4: Participants will check into the study clinic to receive 2 doses (once a week for 2
      weeks) of TAK-105-a or placebo and will stay in the study clinic for about 12 days. They will
      return to the clinic later (in about 1-3 weeks) for another (third) dose and will stay for 2
      days after the third dose. Then, participants return to the clinic for follow-up visits up to
      about 3 months after first dose.

      Part 5a: Participants will check into the study clinic to receive a single dose of TAK-105-a
      or placebo and will stay in the clinic for about 10 days. Then, participants return to the
      clinic for follow-up visits up to about 60 days after the dose.

      Part 5b: Participants will check into the study clinic to receive TAK-105-a or placebo once a
      week for 4 weeks, and will stay in the clinic for about 26 days. Then, participants return to
      the clinic for follow-up visits up to about 60 days after last dose. Part 5b will be
      optional, depending on the pharmacokinetic (PK) and safety data observed in Part 2.

      Part 6: Participants will check into the study clinic to receive a single dose of TAK-105-b
      or placebo and will stay in the clinic for about 10 days. Then, participants return to the
      clinic for follow-up visits up to about 60 days after the dose.
    

Detailed description: 
      The drug being tested in this study is called TAK-105. The study will look at the safety,
      tolerability, and PK of TAK-105-a and TAK-105-b in healthy participants.

      Participants in each cohort will be randomized to receive treatment with TAK-105-a or
      TAK-105-b 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 6
      parts and up to 34 cohorts as mentioned below:

        -  Part 1 (SRD) will enroll healthy participants in up to 12 cohorts.

        -  Part 2 (MRD) will enroll healthy participants in up to 5 ascending cohorts.

        -  Part 3 (Dose titration) will enroll healthy participants in up to 6 multiple-dose
           cohorts.

        -  Part 4 (Redosing) will enroll healthy participants in up to 4 redosing cohorts.

        -  Part 5a (SRD) will enroll healthy Japanese participants in up to 3 cohorts.

        -  Part 5b (MRD) (optional) will enroll healthy Japanese participants in up to 2 cohorts.
           The MRD cohorts in Part 5b will be optional, depending on the PK and safety data
           observed in Part 2 (MRD).

        -  Part 6 (SRD) will enroll healthy participants in up to 2 cohorts.

      Each cohort in all the parts will have 8 randomized participants with 6 participants
      receiving a single dose of TAK-105-a in Parts 1 to 5 or TAK-105-b in Part 6, and 2 receiving
      TAK-105-a matching placebo (Parts 1 to 5) or TAK-105-b matching placebo (Part 6) in a 3:1
      ratio. This multi-center trial will be conducted in the United States. The overall duration
      of the study is approximately 18 months.
    

Intervention name(s): TAK-105-a; TAK-105-a Placebo; TAK-105-b; TAK-105-b Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): TAK-105-a subcutaneous solution.; TAK-105-a placebo-matching solution.; TAK-105-b subcutaneous solution.; TAK-105-b placebo-matching solution.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Drug Therapy