A study of ALMB-0166 administered intravenously to assess tolerability and metabolism of the study drug in healthy participants.

Phase 1

Completed

• Conditions: Spinal cord injury; Injuries and Accidents - Other injuries and accidents

• Registration Number: ACTRN12619001689167
• Lead Sponsor: Avance Clinical Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-02
• Study Completion: 2020-12-31
• Last Update Posted: 7 February 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified