Status:
COMPLETED
AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects
Lead Sponsor:
Axalbion SA
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The main purpose of the study is to see how safe the study drug AX-8 is and how well it is tolerated when administered at different dose levels in healthy participants. The study will also investigat...
Detailed Description
The primary objective of the study is to investigate the safety and tolerability of ascending AX-8 oral doses, i.e. orally disintegrating tablets (ODTs), administrated twice for one day (Day 1) in hea...
Eligibility Criteria
Inclusion
- Healthy male and female volunteers aged ≥ 18 and ≤ 55 years at the time of informed consent
- Female subjects must be either of non-childbearing potential or if of childbearing potential use a highly effective birth control method
- Female subjects (regardless of childbearing potential) must agree not to donate ova/oocytes during the study from the first dosing day and until 30 days after the last dose
- Male subjects with female partners of childbearing potential must be vasectomised with documented medical assessment of the surgical success, or use highly effective contraception together with their female partner(s)
- Male subjects must agree not to donate sperm during the study from the first dosing day and until 90 days after last dose
- Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 at Screening
- Have provided written informed consent
- Are willing and able to comply with all aspects of the protocol
- Normal electrocardiogram (ECG) and vital signs (or abnormalities which the clinical Investigator considers the deviation to be irrelevant for the purpose of the study) during screening and prior to first dose
- Laboratory values within the normal range (or the clinical Investigator considers the deviation to be irrelevant for the purpose of the study) during screening
- Findings within the range of clinical acceptability in medical history and physical examination (or the clinical Investigator considers the deviation to be irrelevant for the purpose of the study)
Exclusion
- Prior treatment with AX-8
- Hypersensitivity or intolerance to transient receptor potential melastatin subfamily, member 8 (TRPM8) agonists (e.g. menthol, menthol-derivatives, eucalyptol) or any of the excipients of the AX-8 tablets
- Current smoker or individuals who have given up smoking for less than 12 months or ex smoker with \> 10 pack-years
- History of upper or lower respiratory tract infection within 4 weeks prior to screening or prior to first dose.
- Requiring concomitant therapy with prohibited medications
- Treatment with biologic therapies within 8 weeks or 5 half-lives, whichever is longer, prior to screening
- Treatment with any investigational therapy within 4 weeks prior to screening
- Serum creatinine, total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> the upper limit of normal (ULN) during screening
- Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or antibodies against human immunodeficiency virus 1 or 2 (HIV-1 and HIV-2 Abs) during screening
- Positive tests for drugs of abuse or alcohol breath test at screening or prior to first dose
- History of malignancy, with the exception of completely treated and non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin, within 5 years prior to screening
- History of a major psychiatric condition (including major depressive disorder, bipolar disorder, or schizophrenia), suicidal ideation, or suicide attempt
- Presence of any medical condition or disability that, in the Investigator's opinion, could interfere with the assessment of safety or efficacy in this study or compromise the safety of the subject
- History or presence of alcoholism or drug abuse within the past 2 years prior to screening
- Females who are currently pregnant, breastfeeding or lactating, or who have a positive pregnancy test at screening or prior to first dose
- Male subjects with a pregnant, breastfeeding or lactating partner or a partner who is planning to become pregnant during the study or within 90 days after the last dose
- Donation of blood (≥ 400 mL) or plasma, or significant blood loss within 56 days prior to screening
Key Trial Info
Start Date :
September 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 4 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04107441
Start Date
September 9 2019
End Date
March 4 2020
Last Update
April 30 2020
Active Locations (1)
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1
Medicines Evaluation Unit (MEU) Ltd
Manchester, United Kingdom, M23 9QZ