None listed
Conditions
Brief summary
This study aims to evaluate the safety and tolerability of an experimental new drug, ALMB-0166 being developed to help prevent patients who experience an acute spinal cord injury from developing secondary injuries.
Interventions
This is a 2-part, Phase I, single-centre, randomised, double-blind, placebo-controlled, sequential cohort study of single and multiple ascending doses of ALMB-0166 or placebo administered by intravenous infusion to healthy adult participants. Participant population to be enrolled in SAD and MAD parts of the study will be mutually exclusive. Part 1 will be single ascending dose (SAD) which will involve at least 4 cohorts testing single incremental doses of 1 mg/Kg, 3 mg/Kg, 10 mg/Kg and 25 mg/Kg.
This is a 2-part, Phase I, single-centre, randomised, double-blind, placebo-controlled, sequential cohort study of single and multiple ascending doses of ALMB-0166 or placebo administered by intravenous infusion to healthy adult participants. Participant population to be enrolled in SAD and MAD parts of the study will be mutually exclusive. Part 1 will be single ascending dose (SAD) which will involve at least 4 cohorts testing single incremental doses of 1 mg/Kg, 3 mg/Kg, 10 mg/Kg and 25 mg/Kg. Part 2 of the study will be a Multiple Ascending Dose (MAD) involving up to 4 dosing levels to be determined after review of Part 1 which will be administered intravenously on Days 1, 8, 15 and 21. Dose escalation will be determined by a Safety Review Committee (SRC) that will review all the safety data available from the previous cohort. In both parts, the SRC should make a recommendation as to whether the next dose should be escalated or reduced, or additional subjects should be dosed in a same dose level of a cohort. Adherence to the protocol intervention for SAD and MAD parts of the study will be performed through direct observation by study personnel since the investigational product will be administered in the phase I unit.
Sponsors
Avance Clinical Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Participants are eligible for the study only if all of the following criteria apply: 1. Healthy male or female subjects between 18 and 55 years, inclusive 2. Negative urine drug screen (UDS) at Screening, and if the UDS is positive, retest it 3. Subject is in good health as indicated by medical history, physical examination, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG), and all abnormal findings are assessed as Not Clinically Significant by the Investigator. 4. Body weight between 45 and 110 kg inclusive, and BMI between 18 and 34 kg/m2 inclusive at Screening. The maximum body weight is 100 kg for subjects to be enrolled in the dose level 25 mg/kg, or above if applicable. 5. Subject is able to speak, read, and understand the language in which the trial is conducted and voluntarily provide written informed consent to participate in the study. 6. If female, the subject must have a negative serum pregnancy test at the Screening visit and a negative urine pregnancy test at check-in to the Research Unit for the first dosing visit or a negative serum pregnancy test 24 hours prior to dosing at subsequent visits in Part 2 and is not nursing or planning a pregnancy. 7. If female, subject must be: a. Surgically sterilized via hysterectomy, bilateral oophorectomy, or bilateral tubal ligation; or b. Of childbearing potential and practicing an acceptable form of birth control (defined as the use of any two of the following: an intrauterine device; a barrier method; condoms, any form of hormonal contraceptives; or abstinence from sexual intercourse) starting 60 days prior to dosing and continuing 30 days following the last treatment. c. Of non-childbearing potential (ie, postmenopausal for at least 1 year with an elevated follicle stimulating hormone (FSH) level consistent with post-menopausal status). 8. If male, subject must be surgically or biologically sterile. If not sterile, the subject must agree to use an acceptable form of birth control with sexual partner (as described in inclusion criteria #7b) or abstain from sexual relations for 30 days following the last treatment. 9. Negative test results for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C at Screening.
Exclusion criteria
Participants are excluded from the study if any of the following criteria apply: 1. History of any drug allergy, hypersensitivity, or intolerance to any drug product that in the opinion of the investigator would place the subject at particular risk and compromise the safety of the subject in the study. 2. History or current diagnosis of substance dependence (except nicotine and caffeine) or alcohol abuse, according to the criteria of DSM-IV-TR. 3. History of traumatic brain injury (TBI) and concussion 4. Subject with a high frequency migraine 5. Subject who practices contact sports within the past 6 months 6. On fluid restriction. 7. Plan to participate in another clinical trial while enrolled in this study and/or who have received an investigational drug and/or device within 30 days prior to admission. 8. Have donated or had significant loss of whole blood (greater than 480 mL) within 30 days or plasma within 14 days prior to admission. 9. History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, psychiatric disease, or any other condition, that in the opinion of the investigator would jeopardize the safety of the subject or the validity of the study results. 10. Receiving any prescription medication(s) within 14 days of dose administration, or any non-prescribed or topical medication (including any herbal product) within 7 days prior to dose administration. 11. Subject who smokes and is unable to stop smoking during the in-patient observation period in the Research Unit. 12. Unwilling to abstain from alcohol for at least 24 hours prior to dosing with study medication until the time of discharge from the study unit, and at least 24 hours prior to each ambulatory visit. 13. QTcF >450 msec for male subjects or >470 msec for female subjects on 3 consecutive ECG recordings conducted at Screening or Baseline. 14. Females who are breastfeeding (if unwilling to stop for the first 60 days following the start of dosing) or who are pregnant. 15. With one of the following conditions where a MRI scan cannot be performed: a. Any electrically, magnetically or mechanically activated implant (e.g. cardiac pacemaker, insulin pump biostimulator, neurostimulator, cochlear implant, and hearing aids) b. Intracranial aneurysm clips (unless made of titanium) c. Ferromagnetic surgical clips or staples. d. Metallic foreign body in the eye e. Metal shrapnel or bullet f. Other conditions that make the subject not suitable for receiving a MRI scan, per PI’s judgement
Outcome results
None listed