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Contact Information:

Dr Jacob Jacobson
None provided
jacob.jacobsen@evecxia.com


Dr Jacob Jacobson
None provided
jacob.jacobsen@evecxia.com


Dr Jacob Jacobson
None provided
jacob.jacobsen@evecxia.com


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Be Part of Research - Trial Details - Phase I Single- and Multiple-Ascending Dose Trial of EVX-101
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Phase I Single- and Multiple-Ascending Dose Trial of EVX-101

Not Recruiting

Open to: All Genders

Age: Adult

Nottingham

Medical Conditions

Depression

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Background and study aims
The Sponsor is developing the test medicine, EVX-101, as a potential adjunctive treatment of depression. Adjunctive treatment is something that is given in addition to initial primary treatment e.g therapy, when the initial treatment is only partially effective. Depression is a common mental health problem that causes people to experience low mood, loss of interest or pleasure, feelings of guilt or low self-worth, disturbed sleep or appetite, low energy and poor concentration. This two-part healthy volunteer study will try to identify what the body does to the test medicine (pharmacokinetics) and to assess the safety and tolerability of the test medicine, given as single and multiple doses.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

15 Mar 2022 20 Oct 2022

This study will take place at one non-NHS site, enrolling up to 40 participants. In order to reflect the intended clinical use of EVX-101, volunteers will receive pre-treatment and co-treatment, at approved doses, to stable blood levels with escitalopram (a marketed product for treatment of depression), both at outpatient visits and at home dosing, before and after test medicine/placebo dosing, for up to 28 days in Part 1 and up to 54 days in Part 2.

Volunteers in Part 1 will receive two doses of the test medicine or placebo on Day 21, which will be given as two equal administrations approx. 12 hours apart. Volunteers return to the unit approximately 7 days after test medicine/placebo dosing and received a follow up phone call 7 to 14 days after their final dose of escitalopram.

Volunteers in Part 2 will receive multiple doses of the test medicine or placebo from Day 21 up to and including Day 47. Doses will be given twice daily as two equal administrations approx. 12 hours apart, with the dose level increased every 7 days. Volunteers returned to the unit approximately 5 days after discharge, received follow up phone calls every 2 days for 6 days and returned for a final follow up visit on Day 61 7.

Volunteer’s blood and urine will be taken throughout the study for analysis of the test medicine and for their safety.

Volunteers are expected to be involved in this study for approximately 12 weeks from screening to the follow up call.


Male and female volunteers aged between 18 to 55 years old.

You can take part if:



You may not be able to take part if:


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 longer2. Subjects who are, or are immediate family members of, a study site or sponsor employee3. Subjects who have previously received 5-HTP/Carbidopa in study EVX101-101/QSC2011404. 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 25. Evidence of current SARS-CoV-2 infection within 4 weeks of Day 16. History of any drug or alcohol abuse in the past 2 years7. 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 19. Results at screening indicative of chronic excess alcohol intake10. 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 111. Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months12. Females who are pregnant or lactating (all female subjects must have a negative highly sensitive pregnancy test)13. Male subjects with pregnant or lactating partners14. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening15. Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the investigator. Subjects with Gilbert’s Syndrome are allowed16. 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 screening17. Clinically significant findings on ECG or vital signs as assessed by the investigator at screening or Day 118. QTcF >450 msec at screening or Day 1 or known QT interval prolongation or congenital long QT syndrome19. 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 results21. History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or neurological disorder, as judged by the investigator22. History of any psychiatric disease requiring treatment in the last 5 years23. Known history of glaucoma or raised intraocular pressure24. Presence or history of any GI disease including peptic ulceration, GI bleeding, ulcerative colitis, Crohn’s Disease25. Subjects with a history of cholecystectomy or gall stones26. 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 128. Serious adverse reaction or serious hypersensitivity to any drug (including serotonergic drugs such as anti-depressants and migraine medication) or the formulation excipients29. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active30. Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood prior to Day 131. Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than up to 4 g of paracetamol per day, contraceptive pill/hormonal contraception or HRT) in the 14 days before escitalopram administration on Day 1. COVID-19 vaccines are accepted concomitant medications. Exceptions may apply, as determined by the investigator, if each of the following criteria are met: medication with a short half-life if the washout is such that no PD activity is expected by the time of dosing with IMP; and if the use of medication does not jeopardise the safety of the trial subject; and if the use of medication is not considered to interfere with the objectives of the study32. Failure to satisfy the investigator of fitness to participate for any other reason



Previous participant exclusion criteria:Healthy volunteer


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Quotient Sciences Limited
    Trent House Mere Way Ruddington Fields Business Park
    Nottingham
    NG11 6JS

Participants will get no medical benefit from taking part in this study. We hope that the development of a product to improve the treatment of depression will be of benefit to patients with this condition
As this is a Phase I study, the most relevant population is healthy volunteers, and it is considered that the risk/benefit evaluation supports this. Females of childbearing potential (non-pregnant or lactating) will be allowed to participate as long as they comply with the contraception requirements detailed in the clinical protocol. There is always a risk that the stipend in healthy volunteer studies could represent coercion. The time spent in the clinic, travel, inconvenience and other expenses factor in calculating the stipend. Perception of risk is not considered in this calculation. Volunteers may experience side effects from the test medicine and/or escitalopram in this study. Full information on possible side effects is provided to volunteers in the Participant Information Sheet and Informed Consent Forms. When investigating new medicines there is always a risk of unexpected side effects and occasionally allergic reactions. Volunteers will be closely monitored during the study. Risks are further mitigated by ensuring that only volunteers who meet all inclusion/exclusion criteria are included and that if the safety of any volunteer represents a concern they will be withdrawn. There will be an extended period of fasting for the volunteers taking part in this study. To ensure an adequate fluid intake, the volunteers will be allowed ad libitum fluids and will be monitored for signs of dehydration and fatigue. Blood samples will be collected during the study. Collection of these samples can cause soreness and bruising of the arms but these problems usually clear up within a few days to a few weeks. ECG stickers on volunteers' chests and limbs may cause some local irritation and may be uncomfortable to remove but volunteers will be closely monitored to ensure any local irritation does not persist. As the test medicine and escitalopram are CNS acting and may have an effect on the volunteers’ mental health, an appropriately trained physician will assess their mood using the C-SSRS questionnaire at regular intervals during the study.

Dr Jacob Jacobson
None provided
jacob.jacobsen@evecxia.com


Dr Jacob Jacobson
None provided
jacob.jacobsen@evecxia.com


Dr Jacob Jacobson
None provided
jacob.jacobsen@evecxia.com



The study is sponsored by Evecxia Therapeutics Inc. and funded by Evecxia Therapeutics Inc..



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Read full details for Trial ID: ISRCTN42835524
Last updated 21 April 2023

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