A Phase I Study of TRN501 in Healthy Volunteers

Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of TRN501 following a single administration of TRN501 or placebo to healthy adult male volunteers.

Conditions

• Parkinson Disease

Interventions

DRUG

TRN501 - Dose 1

Each cohort consists of 9 participants and includes a placebo group. 6 in the TRN501 group and 3 in the placebo group, a total of 9 participants, are randomly assigned in a double-blind fashion. To each participant, single dose of TRN501 or a placebo will be administered.

DRUG

TRN501 - Dose 2

Each cohort consists of 9 participants and includes a placebo group. 6 in the TRN501 group and 3 in the placebo group, a total of 9 participants, are randomly assigned in a double-blind fashion. To each participant, single dose of TRN501 or a placebo will be administered.

DRUG

TRN501 - Dose 3

Each cohort consists of 9 participants and includes a placebo group. 6 in the TRN501 group and 3 in the placebo group, a total of 9 participants, are randomly assigned in a double-blind fashion. To each participant, single dose of TRN501 or a placebo will be administered.

DRUG

TRN501 - Dose 4

Each cohort consists of 9 participants and includes a placebo group. 6 in the TRN501 group and 3 in the placebo group, a total of 9 participants, are randomly assigned in a double-blind fashion. To each participant, single dose of TRN501 or a placebo will be administered.

DRUG

TRN501 - Dose 5

Each cohort consists of 9 participants and includes a placebo group. 6 in the TRN501 group and 3 in the placebo group, a total of 9 participants, are randomly assigned in a double-blind fashion. To each participant, single dose of TRN501 or a placebo will be administered.

DRUG

TRN501 - Dose 6

Each cohort consists of 9 participants and includes a placebo group. 6 in the TRN501 group and 3 in the placebo group, a total of 9 participants, are randomly assigned in a double-blind fashion. To each participant, single dose of TRN501 or a placebo will be administered.

DRUG

TRN501 - Dose 7

Each cohort consists of 9 participants and includes a placebo group. 6 in the TRN501 group and 3 in the placebo group, a total of 9 participants, are randomly assigned in a double-blind fashion. To each participant, single dose of TRN501 or a placebo will be administered.

DRUG

TRN501 - Dose 8

Each cohort consists of 9 participants and includes a placebo group. 6 in the TRN501 group and 3 in the placebo group, a total of 9 participants, are randomly assigned in a double-blind fashion. To each participant, single dose of TRN501 or a placebo will be administered.

Sponsors & Collaborators

• SNLD, Ltd.

  lead INDUSTRY

Principal Investigators

• Akihisa Mori, PhD · SNLD, Ltd.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-05-10

Primary Completion

2024-09-20

Completion

2024-09-20

Countries

• Japan