---
title: DSP-3025 A Phase 1 Study of Healthy Male Volunteers
nct_id: NCT01124396
overall_status: COMPLETED
sponsor: Sumitomo Pharma Co., Ltd.
study_type: OBSERVATIONAL
primary_condition: Healthy
countries: Japan
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01124396.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01124396"
ct_last_update_post_date: 2022-04-12
last_seen_at: "2026-05-12T06:59:20.914Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# DSP-3025 A Phase 1 Study of Healthy Male Volunteers

**Official Title:** A Double-blind, Placebo-controlled, Randomised Study to Investigate the Tolerability, Safety, Pharmacokinetics and Pharmacodynamics of Repeated Weekly Doses of DSP-3025 Administered Intranasally to Healthy Male Volunteers

**NCT ID:** [NCT01124396](https://clinicaltrials.gov/study/NCT01124396)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 24
- **Lead Sponsor:** Sumitomo Pharma Co., Ltd.
- **Conditions:** Healthy
- **Start Date:** 2010-04
- **Completion Date:** 2012-04
- **CT.gov Last Update:** 2022-04-12

## Brief Summary

Investigate safety/tolerability after repeated weekly doses intranasal administration of DSP-3025 comparator placebo to healthy male volunteers

## Eligibility

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

```
Inclusion Criteria:

* Body mass index (BMI) between 18.5 and 25 kg/ m2 and a weight between 50 and 80 kg
* No clinically relevant abnormal findings

Exclusion Criteria:

* Acute illness which requires medical intervention
* Definite or suspected personal history of adverse drug reactions or drug hypersensitivity
* Clinical relevant disease or disorder (past or present)
* A history of respiratory disorder(s) such as asthma
```

## Arms

- **30 ug** — 30 ug
- **60 ug** — 60 ug
- **Placebo** — Placebo

## Interventions

- **DSP-3025** (DRUG)
- **Placebo** (DRUG)

## Primary Outcomes

- **Incidence/nature of adverse events, 12-lead ECG, pulse, BP, body temperature, spirometry** _(time frame: During the study)_

## Secondary Outcomes

- **Clinical chemistry, haematology, urinalysis, autoantibodies** _(time frame: During the study)_
- **Nasal symptoms and peak nasal inspiratory flow** _(time frame: During the study)_
- **Pharmacokinetics** _(time frame: During the study)_
- **Biomarkers nasal lavage and blood** _(time frame: During the study)_

## Locations (1)

- Kitasato University East Hospital, Asamizodai 2-1-1, Minami-ku, Sagamihara, Kanagawa, Japan

## Recent Field Changes (last 30 days)

- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `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.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — 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)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.kitasato university east hospital|asamizodai 2-1-1, minami-ku, sagamihara|kanagawa|japan` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01124396.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01124396*  
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