None listed
Conditions
Brief summary
1. This study is a clinical trial in healthy adults to understand how safe SLTE-1009 is and how the body handles it. 2. SLTE-1009 is an investigational medicine that affects certain brain pathways and is being developed for possible use in Migraine patients. 3. Participants will receive either a single Intravenous dose or multiple subcutaneous doses of the study drug or a placebo, with careful monitoring throughout the study. 4. Doctors will closely monitor participants for side effects, 5. The study uses small groups, step-by-step dosing, and close medical supervision to help ensure participant safety.
Interventions
Part 1: Single Ascending Dose (SAD) part will be conducted as a placebo-controlled single dose study to assess the safety, tolerability, and PK of a single dose of SLTE-1009 administered in healthy adult participants. Participants will be randomized in a 3:1 ratio per cohort (n=8) to receive SLTE-1009 or placebo.
Each participant in SAD will receive SLTE-1009 or placebo as an IV infusion (100mL/hr infusion rate) on Day 1.
Five (5) cohorts are planned, evaluating doses of 50, 150, 300, 600, and
Part 1: Single Ascending Dose (SAD) part will be conducted as a placebo-controlled single dose study to assess the safety, tolerability, and PK of a single dose of SLTE-1009 administered in healthy adult participants. Participants will be randomized in a 3:1 ratio per cohort (n=8) to receive SLTE-1009 or placebo. Each participant in SAD will receive SLTE-1009 or placebo as an IV infusion (100mL/hr infusion rate) on Day 1. Five (5) cohorts are planned, evaluating doses of 50, 150, 300, 600, and 1000 mg. Participants will be admitted to the Clinical Research Unit on Day -1 and will be discharged on Day 2. Two sentinel participants will be deployed in each cohort in the SAD. In the absence of any safety concerns, at the discretion of the Principal Investigator (PI) or designee, the remainder of the cohort will be administered study drug. Part 2: Multiple Ascending Dose (MAD) part will be conducted as a placebo-controlled MAD study to assess the safety, tolerability, and PK of multiple doses of SLTE-1009 administered as a subcutaneous injection in healthy adult participants. Participants will be randomized in a 3:1 ratio per cohort (n=8) to receive SLTE-1009 or placebo. Each participant in MAD will receive a subcutaneous (SC) dose of SLTE-1009 or placebo on Day 1, followed by additional doses at the same dose level on Days 15 and 29. Three (3) cohorts are planned, evaluating doses of 150, 300, and 600 mg but final dose determination will be based on the SAD part of the protocol. Depending on available safety data, the Sponsor along with the SRC may decide to eliminate doses or expand dosing cohorts. Adherence to the intervention will be monitored through direct administration of all doses by qualified study personnel at the Clinical Research Unit. Dosing will be documented in source records and drug accountability records, and participants will be monitored according to the protocol-defined schedule.
Sponsors
Slate Medicines
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
- At the discretion of the PI or designee, in good general health, with no significant medical history, and have no clinically significant abnormalities on physical examination at Screening and/or before the first administration of SLTE-1009. - Body mass index (BMI) between 18.0 and 32.0 kg/m2 and weight more than or equal to 50 and less than or equal to 100 kg - Nonsmoker or smokes less than or equal to 5 cigarettes or equivalent (eg, cigars, vaping, nicotine patches) per week. - Vital signs result within the following normal ranges respiration rate (RR) 10-22, heart rate 40-100, blood pressure (after participant is lying supine for approximately 5 minutes) 90-140, Temp 35.5-37.5-degree Celsius, blood oxygen SpO2 >95% - A woman of childbearing potential (WOCBP) or fertile man must have been using an acceptable method of contraception more than 30 days prior to Screening and agrees to continue using the acceptable method of contraception until 6 months after the last dose of SLTE-1009. - Male participants must agree to not donate sperm for 6 months after last dose of SLTE-1009
Exclusion criteria
- Pregnant, planning to become pregnant, or currently breastfeeding. - Positive serum pregnancy test at Screening or a positive urine pregnancy test on Day -1. - Current or recent systemic infection within 2 weeks prior to Screening or infection requiring IV antibiotics within 4 weeks prior to Screening. - Recent surgery requiring general anesthesia within 12 weeks prior to Screening or is expected to have surgery requiring general anesthesia during the course of the study. - Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m 2 (using the CKD-EPI 2021 formula) - Elevated liver function tests defined as total bilirubin or alkaline phosphatase (ALP), aspartate aminotransferase (AST), or alanine aminotransferase (ALT) =>1.5 × upper limit of normal (ULN) at Screening. - Any of the following: a. Known congenital long QT syndrome. b. Fridericia-corrected QT interval (QTcF) at Screening greater than or equal to 450 ms for a male or greater than or equal to 470 ms for a female. c. Abnormal ECG findings at Screening that are considered by the PI or designee to be clinically significant. - History of malignancy, except for non-melanoma skin cancer, excised more than 1 year prior to Screening and cervical intraepithelial neoplasia that has been successfully cured more than 5 years prior to Screening. - History of severe allergic or anaphylactic reactions, or known sensitivity to SLTE-1009 constituents. - History of stroke or history of stroke before age 50 in first degree relatives - Positive drugs and/or alcohol screen.
Outcome results
None listed