Phase I Single- and Multiple-Ascending Dose Trial of EVX-101
- Conditions
- DepressionMental and Behavioural Disorders
- Registration Number
- ISRCTN42835524
- Lead Sponsor
- Evecxia Therapeutics Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 38
Current participant inclusion criteria as of 21/04/2023:
1. Healthy males or non-pregnant, non-lactating healthy females
2. Aged 18 to 55 years old for Part 1 and aged 25 to 55 years old for Part 2 inclusive at the time of signing informed consent
3. Body mass index (BMI) of 18.0 to 32.0 kg/m2 as measured at screening
4. Weight =50 kg at screening
5. Must be willing and able to communicate and participate in the whole study
6. Must provide written informed consent
7. Must agree to adhere to the contraception requirements defined in the clinical protocol
Previous participant inclusion criteria:
Healthy volunteer
Current participant exclusion criteria as of 21/04/2023:
1. Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1, or less than 5 elimination half-lives prior to Day 1, whichever is longer
2. Subjects who are, or are immediate family members of, a study site or sponsor employee
3. Subjects who have previously received 5-HTP/Carbidopa in study EVX101-101/QSC201140
4. Subjects who have previously been administered IMP (5-HTP/carbidopa GR tablet or placebo) in this study. Subjects who have taken part in Part 1 are not permitted to take part in Part 2
5. Evidence of current SARS-CoV-2 infection within 4 weeks of Day 1
6. History of any drug or alcohol abuse in the past 2 years
7. Regular alcohol consumption in males >21 units per week and females >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)
8. A confirmed positive alcohol breath test at screening or Day 1
9. Results at screening indicative of chronic excess alcohol intake
10. Current smokers and those who have smoked within the last 12 months. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or Day 1
11. Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
12. Females who are pregnant or lactating (all female subjects must have a negative highly sensitive pregnancy test)
13. Male subjects with pregnant or lactating partners
14. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening
15. Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the investigator. Subjects with Gilbert’s Syndrome are allowed
16. Platelet count, serum sodium, potassium or magnesium below the lower limit of the reference range at screening. For Part 2 only, haemoglobin below the lower limit of the reference range at screening
17. Clinically significant findings on ECG or vital signs as assessed by the investigator at screening or Day 1
18. QTcF >450 msec at screening or Day 1 or known QT interval prolongation or congenital long QT syndrome
19. Confirmed positive drugs of abuse test result
20. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results
21. History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or neurological disorder, as judged by the investigator
22. History of any psychiatric disease requiring treatment in the last 5 years
23. Known history of glaucoma or raised intraocular pressure
24. Presence or history of any GI disease including peptic ulceration, GI bleeding, ulcerative colitis, Crohn’s Disease
25. Subjects with a history of cholecystectomy or gall stones
26. Subjects unwilling to eat at least 90% of the pre-dose meals
27. Subject answers yes to Suicidal Ideation Items 1 or 2 on the C-SSRS (lifetime) at screening or Day 1
28. Serious adverse reaction or serious hypersensitivity to any drug (including serotonergic drugs such as anti-depressants and migraine medication) or the formulation excipients
29. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
30. Donation of blood or plasma within the previous 3 months or loss of g
Study & Design
- Study Type
- Other
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method