P-One Clinic (Hachioji, Tokyo) is seeking male participants for an upcoming clinical study with study groups beginning in March, May, June, and July.
Clinical studies (also called “clinical trials”) are scientific tests to check the efficacy and safety of new drugs, medical devices, and healthcare procedures. They are conducted with the cooperation of willing volunteers and governed by the strict legal and ethical guidelines of Good Clinical Practice (GCP). By participating in a clinical study, you play a crucial role in helping to get new medicines to the patients who need them.
P-One Clinic (Hachioji, Tokyo) is seeking male volunteers for an upcoming study. Those who pass the initial selection will be invited to an information/consent session and screening health check. Those who pass the screening will be invited to take a PCR test and then to participate in a test of a drug. They will stay overnight at the clinic as part of either the single dose part or multiple dose part and will join one of 5 possible groups. Those who join the single dose part will stay at the clinic for 7 nights and then return for 9 follow-up health checks. Those who join the multiple dose part will stay at the clinic on 3 separate occasions, for a total of 19 nights, and will return to the clinic for a total of 8 follow ups.
BASIC PARTICIPATION REQUIREMENTS
•You are a male from 20 to no more than 65 years of age
•You weigh at least 50 kg and have a BMI (body mass index) from 18.0 to no more than 32.0
•Healthy based on medical history and testing/examinations
*No participation in other studies for 4 months
*You can consent to use contraception throughout study
*Detailed criteria will be provided to applicants.
SCHEDULE
Single Dose Part
Group 6
Screening: Mar 24 (begins at approximately 9:30 am and lasts approximately 3 hours)
PCR Test: Apr 8, time TBA
Clinic Stay: Apr 13 to Apr 21
Follow-ups: Apr 24, Apr 28, May 6, May 11, May 24, June 8, June 23, July 4
Group 7
Screening: Early May, time and date TBA
PCR Test: Time and date TBA
Clinic Stay: May 24 to May 31
Follow-ups: June 2, June 4, June 8, June 15, June 22, July 6, July 20, Aug 1, Aug 17
Group 8
Screening: Late June, time and date TBA
PCR Test: Time and date TBA
Clinic Stay: Jul 10 to Jul 17
Follow-ups: Jul 19, Jul 21, Jul 25, Aug 1, Aug 8, Aug 21, Sep 5, Sep 19, Oct 3
Multiple Dose Part
Group 2
Screening: Mid May, date and time TBA
PCR Test: Date and time TBA
First Clinic Stay: Jun 15 to Jun 22
First Stay Follow-ups: Jun 24, Jun 26
Second Clinic Stay: Jun 29 to Jul 4
Second Stay Follow-up: Jul 6
Third Clinic Stay: Jul 13 to Jul 20
Third Stay Follow-ups: Jul 24, Jul 28, Aug 11, Sep 8, Oct 6
Group 3
Screening: Early July, date and time TBA
PCR Test: Date and time TBA
First Clinic Stay: Jul 20 to Jul 27
First Stay Follow-ups: Jul 29, Jul 31
Second Clinic Stay: Aug 3 to Aug 8
Second Stay Follow-up: Aug 10
Third Clinic Stay: Aug 17 to Aug 24
Third Stay Follow-ups: Aug 29, Sep 1, Sep 15, Oct 13, Nov 10
*All participants will be compensated for their transportation and time. Please email info@medical-volunteer-network.com or apply for details.
If you interested in joining this study, the first step is to register with MVN. Click the button below for our registration page. For questions, email info@medical-volunteer-network.com
Medical Volunteer Network (MVN) connects non-Japanese volunteers with P-One Clinic, a medical research center in western Tokyo that specializes in clinical studies. Since P-One Clinic was established in 2005, it has completed over 200 studies and more than a dozen with non-Japanese volunteers.