A Phase 1, Double-blind, Single and Multiple-Dose Study of Safety, Tolerability and Pharmacokinetics of Amilo-5MER in Healthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- amilo-5MER
- Conditions
- Inflammatory Disease
- Sponsor
- Galmed Pharmaceuticals Ltd
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- Safety and tolerability of amilo-5ER
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This is a three-part, single Centre, double-blind, randomized, placebo-controlled first-in-human study of single ascending doses (SADs, Part 1) and multiple doses (Part 2) of amilo-5MER in healthy young adult male subjects and a single dose cohort in healthy elderly male and female subjects (Part 3)
Detailed Description
This is a three-part, single Centre, double-blind, randomized, placebo-controlled first-in-human study of single ascending doses (SADs, Part 1) and multiple doses (Part 2) of amilo-5MER in healthy young adult male subjects and a single dose cohort in healthy elderly male and female subjects (Part 3). The study aim is to assess and characterize the safety and tolerability of single and multiple doses of amilo-5MER in healthy young adult subjects and single doses in healthy elderly subjects.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy males (all parts) or healthy females (Part 3 only).
- •Aged 18 to 45 years (Parts 1 and 2) or aged 65 to 80 years (Part 3) inclusive at the time of signing informed consent.
- •Body mass index (BMI) of 19.0 to 31.0 kg/m2, with a body weight \<95 kg, as measured at screening.
- •Willing and able to communicate and participate in the whole study.
- •Provided a written informed consent.
- •Agreed to adhere to the contraception requirements
Exclusion Criteria
- •Subjects who had received any IMP in a clinical research study within the 90 days prior to Day
- •Subjects who were, or were immediate family members of, a study site or sponsor employee.
- •Subjects who had previously been administered IMP in this study. Subjects who took part in Part 1 were not permitted to take part in Part
- •Evidence of recent SARS-CoV-2 symptomatic infection within the last 3 months. Subjects who had asymptomatic, incidental, positive polymerase chain reaction (PCR) findings could have been included if tested more than 30 days prior to screening and test negative at screening.
- •History of any drug or alcohol abuse in the past 2 years.
- •Regular alcohol consumption in males \>21 units per week and females (Part 3 only) \>14 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type).
- •A confirmed positive alcohol breath test at screening or admission.
- •Current smokers and those who had smoked within the last 6 months. A confirmed breath carbon monoxide (CO) reading of greater than 10 ppm at screening or admission.
- •Current users of e-cigarettes and nicotine replacement products and those who had used these products within the last 6 months.
- •Females of childbearing potential including those who were pregnant or lactating (all female subjects must have had a negative highly sensitive urine and serum pregnancy test). A woman was considered of childbearing potential unless she was permanently sterile (hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) or was postmenopausal (had no menses for 12 months without an alternative medical cause and a serum follicle stimulating hormone \[FSH\] concentration ≥30 IU/L) at screening and admission visit (Part 3 only).
Arms & Interventions
A- amilo-5MER solution for subcutaneous administration or matching placebo- 10 mg
Amilo-5MER solution for subcutaneous administration or matching placebo at a dose of 10 mg
Intervention: amilo-5MER
B- amilo-5MER solution for subcutaneous administration or matching placebo- 30 mg
Amilo-5MER solution for subcutaneous administration or matching placebo at a dose of 30 mg
Intervention: amilo-5MER
C- amilo-5MER solution for subcutaneous administration or matching placebo- 90 mg
Amilo-5MER solution for subcutaneous administration or matching placebo at a dose of 90 mg
Intervention: amilo-5MER
D- amilo-5MER solution for subcutaneous administration or matching placebo- 180 mg
Amilo-5MER solution for subcutaneous administration or matching placebo at a dose of 180 mg
Intervention: amilo-5MER
E- amilo-5MER solution for subcutaneous administration or matching placebo- 360mg
Amilo-5MER solution for subcutaneous administration or matching placebo at a dose of 360 mg
Intervention: amilo-5MER
Outcomes
Primary Outcomes
Safety and tolerability of amilo-5ER
Time Frame: 10 days
Assess and characterize the number of participants with clinically significant changes in safety assessments, including adverse events, physical examination findings, vital signs, clinical laboratory assessments, and urinalysis.
Secondary Outcomes
- PK- Area under the concentration-time curve (AUC)(10 days)
- PK- Maximum observed concentration (Cmax)(10 days)
- PK- Time of maximum observed concentration (Tmax)(10 days)
- PK- Total body clearance (CL/F)(10 days)