A First-in-Human study of PA-001 in adult subjects (COVID-19)

JRCT ID: jRCTs031210601

Registered date:07/02/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Healthy adult
• Date of first enrollment: 21/02/2022
• Target sample size: 30
• Study type: Interventional
• Intervention(s): single administration of PA-001

Outcome(s)

Primary Outcome

(1) Adverse events
(2) Injection site reaction
(3) Vital signs (temperature, blood pressure, pulse, SpO2)
(4) twelve lead electrocardiogram
(5) laboratory test

Secondary Outcome

(1) plasma concentrations of PA-001
(2) pharmacokinetics parameters of PA-001
Cmax,Tmax,kel,T1/2,AUC0-t,AUC0-inf,CLtot,Vd and MRT

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 40age old
• Gender: Male

Include criteria

(1) Healthy Japanese male adult .
(2) Signed informed consent with their willingness to participate in this clinical study.
(3) Ages 20 - 40 years old.
(4) Subjects has a body weight over 50 kg, and a BMI between 18.5 and 25.0 kg/m2, both inclusive.

Exclude criteria

(1) History of central nervous system, cardiac, respiratory, hematopoietic, gastrointestinal, hepatic or renal disease that could be considered inappropriate for this study.
(2) History of drug allergy.
(3) History of food allergy or allergic disease.
(4) Constitution that get rash as hypersensitivity.
(5) History of drug or alcohol abuse.
(6) Any positive result on immunological test at screening for hepatitis B surface antigen, hepatitis c virus antibody, serological test for syphilis, treponema pallidum test, HIV test.
(7) Any positive result on COVID-19 test at hospitalization.
(8) Any positive result on urine drug test at screening.
(9) Using any drug within two weeks before administration.
(10) Subject who have participated in another clinical trial of new active ingredient within the prior 16 weeks or who have participated in another clinical trial of already approved ingredients within the prior 12 weeks
(11) Subject who donated of 400 mL blood within 12 weeks or of 200 mL blood within 4 weeks, or of blood components within 2 weeks before the administration.
(12) Subjects who are not able to contraceptive from administration to follow-up visit.
(13) Subjects who have an abnormal clinical significance of screening laboratory test, vital signs, electrocardiogram and physical examinations.
(14) Assessment as ineligible by the investigators.

Related Information

• Primary Sponsor: Yonemura Takuma
• Secondary Sponsor: PeptiAID Inc.