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Completed

NCT Number: NCT01124396

DSP-3025 A Phase 1 Study of Healthy Male Volunteers

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

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Key information

Conditions

Healthy

Age range

20 year–39 year

Sex eligibility

Male

Study type

Observational

Primary location

Kitasato University East Hospital

Asamizodai 2-1-1, Minami-ku, Sagamihara, Kanagawa, 252-0380, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DSP-3025

Drug

Placebo

Drug

Primary outcomes

  1. Incidence/nature of adverse events, 12-lead ECG, pulse, BP, body temperature, spirometry

    Time frame: During the study

Secondary outcomes

  1. Clinical chemistry, haematology, urinalysis, autoantibodies

    Time frame: During the study

  2. Nasal symptoms and peak nasal inspiratory flow

    Time frame: During the study

  3. Pharmacokinetics

    Time frame: During the study

  4. Biomarkers nasal lavage and blood

    Time frame: During the study

Sponsors and collaborators

Lead sponsor

Sumitomo Pharma Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2012
First posted
May 17, 2010
Registry last updated
Apr 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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