A Phase 1, Open-Label, Single-Center Study Evaluating Absolute Bioavailability, Safety and Tolerability of Subcutaneous Formulation of RYI-018 Compared to Intravenous Formulation in Overweight and Obese Healthy Volunteers

Bird Rock Bio, Inc.0 sites20 target enrollmentSeptember 18, 2018

Overview

No summary available.

Registry

who.int

Start Date

September 18, 2018

End Date

March 2, 2019

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

•Healthy males and females of 18 to 45 years of age inclusive, at the time of signing the informed consent.
•\-Participants who give voluntary consent and those who are medically healthy with clinically insignificant screening results (e.g., laboratory profiles, medical history, ECGs, physical exam) as judged by the Investigator.
•\-BMI equal to, or greater than 25\.0, but less than or equal to 40\.0 (kg/m2\)
•\-Participants should use highly effective, double barrier contraception (both male and female partners) during the study and 90 days following last dose of RYI\-018\. Male partners of female patients and female partners of male
•\-patients must also use contraception, if they are of childbearing potential.
•\-Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day \-1\. Females not of childbearing potential must be postmenopausal (defined as cessation of regular menstrual periods for at least 12 months), confirmed by follicle stimulating hormone (FSH) level \>40 mIU/mL or surgically sterile.

•Participants are excluded from the study if any of the following criteria apply:
•Medical Conditions \-
•1\. Positive testing for, human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV).
•2\. Have any known malignancy or history of malignancy, except for basal cell skin cancer that has been treated with no evidence of recurrence for at least 3 months before Baseline.
•3\. History of cerebrovascular disease, coronary artery disease, seizures, major depression, suicidality, or unexplained syncope.
•4\. Have any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the participant will comply with the study.
•5\. Have evidence of any chronic medical condition (e.g., hypertension, asthma, or diabetes). Participants with a history of childhood asthma which is not currently active are allowed.
•6\. Active clinically significant infection within 7 days of Baseline.
•7\. Any acute illness, deemed clinically significant by Investigator, within 30 days prior to Baseline
•8\. History or presence of alcoholism or drug abuse within the 2 years prior to Baseline.