A study to evaluate the Absolute Bioavailability, Safety and Tolerability of Subcutaneous Formulation of RYI-018 Compared to Intravenous Formulation in Overweight and Obese Healthy Volunteers

Phase 1

Completed

• Conditions: Overweight; Obesity; Diet and Nutrition - Obesity

• Registration Number: ACTRN12618001557224
• Lead Sponsor: Bird Rock Bio, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-18
• Study Completion: 2019-03-02
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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.

Exclusion Criteria

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.
9. Surgery within the past three months prior to the first study intervention administration determined by the Investigator to be clinically relevant.
Prior/Concomitant Therapy -
10. Use of any prescription or over-the counter medication (with the exception of oral
contraceptives or paracetamol) within 7 days of Baseline.
Prior/Concurrent Clinical Study Experience
11. Administration of investigational product in another study within 30 days prior to
Baseline.
Diagnostic assessments -
12. Any clinically significant laboratory abnormality.
13. Aspartate aminotransferase (AST) or alanine transaminase (ALT) > upper limit of normal (ULN). One repeat test may be allowed within 7 days at the discretion of the Investigator.
Other Exclusions -
14. Positive urine drug screen/alcohol breathalyzer test at Screening and Day -1.
15. Smokers who have smoked more than the equivalent of 2 cigarettes (by declaration, including tobacco or nicotine products) within 6 months prior to Screening. No current use of any nicotine containing product. Cotinine test positive at Screening and Day -1.
16. Blood donation or significant blood loss within 60 days prior to Baseline.
17. Plasma donation within 7 days prior to Baseline.
18. Failure to satisfy the Investigator of fitness to participate for any other reason.
19. Females who are pregnant or lactating. Females should not breast feed for 6 months after last dose of RYI-018.
20. Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = 250 mL of beer, 25 mL of 40% spirit, or a 125-mL glass of wine) within 2 months prior to Screening.

Study & Design

• Study Type: Interventional
• Study Design: Not specified