None listed
Conditions
Brief summary
Depression and anxiety are common mental health disorders that result in individual suffering and have a significant socio-economic impact. In New Zealand, approximately 1 in 7 people will experience depression during their lifetime. Traditional antidepressants often take weeks to months to positively affect mood but are ineffective in approximately 30% of all patients, which often leads to treatment resistant depression (TRD). Treatment of TRD is difficult and may include different pharmacological treatments, or brain stimulation therapies (which are often accompanied by intolerable side effects). However, no single treatment is effective for all TRD patients and there is a significant medical need for effective TRD therapies that are fast-acting and less invasive. As such, there is an urgent need to improve and expand therapeutic options for these TRD patients. This study will provide critical data and will inform the ongoing development of VLS-01 in the treatment of TRD.
Interventions
VLS-01 is being developed as a potential anti-depressant treatment for Treatment-resistant depression (TRD). This Phase 1 study will investigate the effects of VLS-01 in healthy participants, when administered buccally (between the cheeks and gums) as “VLS-01-BU” and when administered via intravenous infusion (infusion into the vein) as “VLS-01-IV”.
The study will be comprised of two parts (Part 1 and Part 2) and will include 48 healthy participants, from New Zealand Clinical Research (NZCR). P
VLS-01 is being developed as a potential anti-depressant treatment for Treatment-resistant depression (TRD). This Phase 1 study will investigate the effects of VLS-01 in healthy participants, when administered buccally (between the cheeks and gums) as “VLS-01-BU” and when administered via intravenous infusion (infusion into the vein) as “VLS-01-IV”. The study will be comprised of two parts (Part 1 and Part 2) and will include 48 healthy participants, from New Zealand Clinical Research (NZCR). Part 1 will be comprised of 8 participants, all of whom will receive a single 30mg dose of VLS-01 as an intravenous (IV) infusion (VLS-01-IV). Part 1 will be split into 2 groups of 4 participants each, and all safety and pharmacokinetic (PK) data from the first 4 participants will be reviewed before enrolling the remaining 4 participants in Part 1. Part 2 will be consist of 5 cohorts, with each cohort being comprised of 8 participants each. The cohorts within Part 2 will enroll in sequential order, and depending on when participants join the study, they will enroll in either Cohort 1, 2, 3, 4, or 5 to receive 10mg, 25mg, 45mg, 65mg, or 80mg, respectively. Participant's in Part 2 will receive a single dose of VLS-01 (at the respective dose) via the buccal route (a thin buccal strip(s) placed between the cheeks and gums). After the last participant in each cohort has dosed, all available safety data will be reviewed by the Safety monitoring group (SMG) to determine whether to proceed to the next cohort. Part 1 and 2 will run parallel to each other and the next cohort will not begin until SMG review has been completed and it is confirmed dosing can continue. The stategies that will used to monitor adherance to the intervention would be monitored dosing where all doses of VLS-01-IV and VLS-01-BU will be administered in the presence of the Investigator or their designee.
Sponsors
Viridia Life Sciences Australia Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
21 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female 21 to 45 years of age, inclusive, at time of consent. 2. Female participants must have a negative serum pregnancy test result at Screening and a negative urine pregnancy test at admission to the CRU, are not currently breast-feeding, and must meet one of the following criteria: a. Undergone 1 of the following sterilization procedures at least 6 months before the first dosing: i. hysteroscopic sterilization ii. bilateral tubal ligation or bilateral salpingectomy iii. hysterectomy iv. bilateral oophorectomy v. Essure sterilization; or b. Be postmenopausal with amenorrhea for at least 1 year before the first dosing and follicle-stimulating hormone (FSH) serum levels consistent with postmenopausal status. c. Female participants of childbearing potential must use at least one of the following protocol-specified highly effective methods or effective methods of birth control and must agree to use barrier contraception (male condom) during heterosexual intercourse, from the time of Screening until at least 90 days after VLS-01 administration as described in the protocol.. 3. Participant weighs more than or equal to 50 kg and less than or equal to 100 kg and has a body mass index (BMI) more than or equal to 18.0 kg/m2 and less than or equal to 32.0 kg/m2, inclusive, at Screening. 4. Participants who smoke no more than 2 cigarettes, pipes, cigars, e-cigarettes or equivalent per week, including nicotine products, can be included in the study but must be willing to abstain from smoking/using nicotine products for 24 hours before VLS-01 administration and during the confinement period.
Exclusion criteria
Participants who meet any of the following criteria will be excluded from this study: 1. Known allergy or hypersensitivity to VLS-01-BU and VLS-01-IV (DMT) or any of the excipients in the formulation. 2. History of clinically significant cardiovascular, cerebrovascular, or peripheral vascular disease, including but not limited to unstable angina, myocardial infarction, congestive heart failure, cardiac arrhythmia, hypertension, hypotension, bradycardia, or tachycardia. and as determined by the protocol. 3. History of seizures, convulsions, or increased intra-cranial pressure with the exception of pediatric febrile seizures. 4. Poor venous access for participants administered VLS-01-IV, or participants with existing buccal lesions or abnormalities that could confound the oral administration of VLS-01-BU or the oral examination. 5. Has an active malignancy, or history of malignancy, excluding basal or squamous cell carcinoma of the skin, within 2 years before screening. 6. Positive test results for hepatitis B surface antigen, hepatitis C virus antibody, or anti-human immunodeficiency virus (HIV) type 1 antibody; participants with prior recovered HBV infection will be included with confirmed normal liver function tests; and participants with positive hepatitis C virus antibody results, but who have been effectively treated for hepatitis C as evidenced by a negative hepatitis C ribonucleic acid (RNA) confirmation test, and who no longer require antiviral therapy, are eligible for participation. 7. Has taken compound(s) known to induce or inhibit cytochrome P450 (CYP) drug metabolizing enzymes (eg, rifampin, cimetidine, or barbiturates) within 30 days before dosing, including herbal supplements, grapefruit juice or products, Seville orange juice or related products, or St. John’s wort. 8. Has received a monoamine oxidase inhibitor within 14 days of screening. 9. Has received treatment with another investigational drug, investigational device, or approved therapy for investigational use within 30 days or 5 half-lives (whichever is longer) before dosing; prior participation at any time in non-invasive methodology trials in which no drugs were given is acceptable. 10. Has donated blood or plasma within 30 days before screening, or had a loss of whole blood of more than 500 mL within the 30 days before screening, or receipt of a blood transfusion within one year before screening. 11. Has experienced symptoms of acute illness or chronic disease within 14 days before Screening, or any disease or condition (medical or surgical) that, by the determination of the PI, might compromise interpretation of safety or PK data, or would place the participant at risk as a result of participation in the study.
Outcome results
None listed