A RELATIVE AND ABSOLUTE BIOAVAILABILITY STUDY OF AMY109 WITH HEALTHY MALE VOLUNTEERS

JRCT ID: jRCT2071220046

Registered date:27/08/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Endometriosis
• Date of first enrollment: 07/10/2022
• Target sample size: 60
• Study type: Interventional

Intervention(s)

AMY109 is administered subcutaneously at the prescribed dose.
AMY109 is administered intravenously at the prescribed dose.

Outcome(s)

Primary Outcome

Safety, Bioavailability, Phamacokinetics
Adverse Events and Adverse Drug Reactions
Vital Signs
12 lead ECG
Laboratory Values
Plasma AMY 109 concentration and pharmacokinetic parameters

Secondary Outcome

Other
Anti-AMY109 antibody in plasma

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 55age old
• Gender: Male

Include criteria

Written informed consent must be obtained from the subject.
Body mass index (BMI) between 18.5 and < 30.0 kg/m2 at screening.

Exclude criteria

Subject with cardiovascular disease, renal disease, hepatic disease, gastrointestinal disease, hematological disease, immunological disease, neurological disease, endocrine disease, metabolic disease, or pulmonary disease.
History of malignancy or leukemia within 10 years before screening.

Related Information

• Primary Sponsor: Hashimoto Akiko