None listed
Conditions
Brief summary
This study of RYI-018 will be conducted in 20 healthy participants with a BMI between 25.0 and 40.0 kg/m2. The participants will be randomized in to one of two treatment arms, each arm having 10 participants. The study will estimate the absolute bioavailability of a sub-cutaneous formulation versus an IV formulation, as well as assess the safety and tolerability of RYI-018. Participants will receive a single dose of RYI-018 (after an overnight fast of at least 10 hours) and will be confined for approximately 24 hours after RYI-018 administration. All participants will be followed-up through 90 days post-dose. It is hypothesised that the subcutaneous formulation will work in the same way as the intravenous formulation, allowing for easier administration of RYI-018 and subsequently higher treatment compliance.
Interventions
This study will be conducted in 20 healthy participants with a BMI of 25.0 to 40.0 kg/m2. Subjects will undergo screening procedures within 21 days of dosing day. Eligible subjects will be randomized in a 1:1 ratio to the following RYI-018 treatment arms (10 participants in each treatment arm):
- Treatment Arm 1: 100 mg of RYI-018 SC injection will be given in the abdomen in a 1 mL syringe
- Treatment Arm 2: 100 mg of RYI-018 IV in 100 mL of 0.9% normal saline infused over approximately 30 minut
This study will be conducted in 20 healthy participants with a BMI of 25.0 to 40.0 kg/m2. Subjects will undergo screening procedures within 21 days of dosing day. Eligible subjects will be randomized in a 1:1 ratio to the following RYI-018 treatment arms (10 participants in each treatment arm): - Treatment Arm 1: 100 mg of RYI-018 SC injection will be given in the abdomen in a 1 mL syringe - Treatment Arm 2: 100 mg of RYI-018 IV in 100 mL of 0.9% normal saline infused over approximately 30 minutes Randomization will be stratified according to baseline BMI; stratification groups will be defined as follows: - Participants with BMI 25.0 to 32.5 kg/m2 (inclusive) - Participants with BMI >32.5 to 40.0 kg/m2 Subjects will receive a single administration of study intervention (after an overnight fast of at least 10 hours) and will be confined to the Phase 1 unit for approximately 24 hours after RYI-018 administration (through Day 2) for PK, tolerability and safety assessments. Subsequently, all participants will be followed-up for PK and safety assessments through 90 days post-dose.
Sponsors
Bird Rock Bio, Inc.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Outcome results
None listed