---
title: First-in-Human Dose Escalation Study of M201-A in Healthy Japanese Subjects
nct_id: NCT03055403
overall_status: COMPLETED
phase: PHASE1
sponsor: Yuji KUMAGAI
study_type: INTERVENTIONAL
primary_condition: Healthy Volunteers
countries: Japan
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03055403.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03055403"
ct_last_update_post_date: 2021-11-30
last_seen_at: "2026-05-12T06:16:24.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# First-in-Human Dose Escalation Study of M201-A in Healthy Japanese Subjects

**Official Title:** A Randomized, Double-Blind, Placebo-Controlled, Single Continuous Intravenous Injection, Dose Escalation, Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of M201-A in Healthy Japanese Subjects

**NCT ID:** [NCT03055403](https://clinicaltrials.gov/study/NCT03055403)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 40
- **Lead Sponsor:** Yuji KUMAGAI
- **Collaborators:** Aetas Pharma Co. Ltd.
- **Conditions:** Healthy Volunteers
- **Start Date:** 2017-02-17
- **Completion Date:** 2017-11-28
- **CT.gov Last Update:** 2021-11-30

## Brief Summary

This Phase I first-in-human is designed to evaluate the safety, tolerability and pharmacokinetics of single ascending doses of M201-A administered by single continuous intravenous injection in Healthy Japanese subjects.

## Detailed Description

Not Provided

## Eligibility

- **Minimum age:** 20 Years
- **Maximum age:** 39 Years
- **Sex:** MALE
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study:

* Japanese Healthy Male subjects
* Age 20 to less than 40 years of age
* Body Mass Index (BMI) of 18.5 to less than 25.0 kg/m2
* Written informed consent must be obtained on a voluntary basis before any assessment is performed.

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment:

* Presence or past medical history of hepatic impairments, renal impairments, cardiovascular disease, gastrointestinal disease and others which are inappropriate for participating in this clinical trial
* Past medical history of cancer, cerebral infarction or cardiac infarction
* Presence or past medical history of allergic reactions or idiosyncrasies to food, medicinal substance and metallic materials
* QTcF \> 450ms at the screening examination
* NT-proBNP \> 125 pg/mL at the screening examination
* Any risk factors of Torsades de Pointes including such as heart failure, hypokalemia, long QT interval syndrome due to family medical history
```

## Arms

- **M201-A Injection** (EXPERIMENTAL) — Active Substance: M201-A Route of administration: continuous intravenous injection
- **Placebo** (PLACEBO_COMPARATOR) — Saline Placebo for M201-A Route of administration: continuous intravenous injection

## Interventions

- **M201-A Injection** (DRUG) — Active Substance: M201-A Route of administration: continuous intravenous injection
- **Placebo** (DRUG) — Saline Placebo for M201-A Route of administration: continuous intravenous injection

## Primary Outcomes

- **Number of participants with adverse events as a measure of safety and tolerability** _(time frame: Throughout the study duration (up to day8))_ — adverse events, serious adverse events, physical examinations, vital sign measurements, 12-lead ECGs, Holter ECG, clinical laboratory safety tests (including hematology, chemistry, and urinalysis), recording of concomitant medications and procedures.

## Secondary Outcomes

- **Pharmacokinetics-Cmax** _(time frame: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A)_
- **Pharmacokinetics-Tmax** _(time frame: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A)_
- **Pharmacokinetics-AUC0-24** _(time frame: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A)_
- **Pharmacokinetics-AUC0-t** _(time frame: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A)_
- **Pharmacokinetics-AUC0-∞** _(time frame: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A)_
- **Pharmacokinetics-t1/2** _(time frame: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A)_
- **Pharmacokinetics-CL** _(time frame: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A)_
- **Pharmacokinetics-Vd** _(time frame: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A)_
- **Pharmacokinetics-E0-24** _(time frame: up to 24 hours)_
- **Pharmacokinetics-Ae** _(time frame: up to 24 hours)_

## Locations (1)

- Clinical Trial Center, Kitasato University Hospital, THE KITASATO INSTITUTE, Sagamihara, Kanagawa, Japan

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.clinical trial center, kitasato university hospital, the kitasato institute|sagamihara|kanagawa|japan` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03055403.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03055403*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*