Focal Onset SeizurePhase 1NCT07918469
A Clinical Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered Cannabidiol Capsules (AVAT-121) and Epidyolex® in Healthy Adults
A Phase 1 study testing AVAT-121 and AVAT-121 and Epidyolex® in people with Focal Onset Seizure, run by Avata Biosciences Holdings Ltd.
Trial summary
This Phase 1 study will evaluate the safety, tolerability, and pharmacokinetics of AVAT-121 in healthy adults. The study includes three parts: Part A: single ascending dose. Part B: comparison of AVAT-121 with Epidyolex®, under fed and fasted conditions. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Focal Onset Seizure
- What is being tested?
- AVAT-121 and AVAT-121 and Epidyolex®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2026to 30 Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) between ≥ 18.0 and ≤ 32.0 kg/m2 and weight ≥ 60 kg
- Not pregnant or breastfeeding, or willing to cease breastfeeding
- Woman of childbearing potential (WOCBP) or fertile man agrees to use a male condom combined with a highly effective method of contraception from the start of Screening (hormonal contraceptives must have commenced at least 30 days prior to Screening) until 90 days after the last dose of IP.
- Adequate venous access in both arms.
- Japanese participants must be up to third generation Japanese lineage, which is defined as, the participant's, biological grandparents as 100% Japanese, and were all born in Japan. Non-Japanese participants must not meet these criteria.
Who cannot join
- Any history or evidence of any clinically significant renal, hepatic, gastrointestinal (history of appendectomy is permitted), cardiovascular, respiratory (history of childhood asthma is permitted), hematologic, dermatologic (history of eczema is permitted provided there has been no use of topical steroid creams within 3 months prior to Screening), autoimmune, endocrine (history of fully resolved gestational diabetes is permitted), inflammatory, neurological, or any uncontrolled medical condition that, in the opinion of the PI or designee, could jeopardize the safety of the participant, prevent complete participation in the study, or compromise interpretation of study data.
- Any psychiatric condition requiring pharmacological management within 6 months prior to Screening, current or prior psychotic disorder, schizophrenia or bipolar disorders, or current suicidal ideation or behavior including a response of "Yes" to C-SSRS Questions 4 or 5, or any positive response to the suicidal behavior section of the C-SSRS.
- Participants with current or past history of acute or chronic liver disease of any etiology.
- Donation of plasma within 7 days prior to first administration of IP or donation or loss of 500 mL or more of whole blood within 30 days prior to first administration of IP.
- Fever (tympanic temperature > 38°C) or symptomatic viral or bacterial infection within 14 days prior to Screening.
- History of malignancy, except for non-melanoma skin cancer, excised more than 2 years ago and cervical intraepithelial neoplasia that has been successfully cured more than 5 years prior to Screening.
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- History or presence of a condition associated with significant immunosuppression.
- Positive urine drug test (including barbiturates, tetrahydrocannabinol [THC], amphetamines, methamphetamines, methadone, methylenedioxymethamphetamine [MDMA], phencyclidine [PCP] benzodiazepines, opiates, tricyclic antidepressants and cocaine), urine cotinine test or alcohol breath test
- History or evidence or renal disease or estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 at Screening, calculated by the 2021 chronic kidney disease epidemiology collaboration (CKD-EPI) creatinine equation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 1, Single Center, Open-Label, Single Ascending Dose and Multiple Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral Cannabidiol Capsules (AVAT-121) and Epidyolex® in Healthy Male and Female Adult Participants, Including Japanese Adults
This Phase 1 study will evaluate the safety, tolerability, and pharmacokinetics of AVAT-121 in healthy adults.
The study includes three parts:
Part A: single ascending dose.
Part B: comparison of AVAT-121 with Epidyolex®, under fed and fasted conditions.
Part C: multiple-dose testing
Up to 44 participants will be enrolled in this study.
- Conditions
- Focal Onset Seizure
- Being tested
- AVAT-121, AVAT-121 and Epidyolex®
- Medical subject headings
- Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVAT-121Drug
12 participants will receive single ascending doses of AVAT-121 (200 mg, 400 mg, and 800 mg).
Route of administration: Oral
AVAT-121 and Epidyolex®Drug
12 participants will receive single doses of 600 mg AVAT-121 and 600mg Epidyolex® under both fed and fasted conditions.
Route of administration: Oral
AVAT-121Drug
20 participants (12 non-Japanese and 8 Japanese) will receive AVAT-121 administered under fed conditions using a multiple-dose titration regimen of 200 mg twice daily for 2 days (400mg/day), followed by 400 mg twice daily for 2 days (800mg/day), followed by 600 mg twice daily for 6 days(1200mg/day).
Route of administration: Oral
| Study group | Role | What they receive |
|---|---|---|
| Part A- Single ascending doses of AVAT-121. | Experimental | Not described Receives: Drug: AVAT-121 |
| Part B - Relative Bioavailability and Food Effect Evaluation | Experimental | Not described Receives: Drug: AVAT-121 and Epidyolex® |
| Part C - Multiple ascending doses of AVAT-121 | Experimental | Not described Receives: Drug: AVAT-121 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of TEAEs (Part A)
Measured: From Day 1 to Day 14 (EOS visit)
Incidence of TEAEs (Part B)
Measured: From Day 1 to Day 14 (EOS visit)
Incidence of TEAEs (Part C)
Measured: From Day 1 to Day 31 (EOS visit)
Incidence of SAEs (Part A)
Measured: From Day 1 to Day 14 (EOS visit)
Incidence of SAEs (Part B)
Measured: From Day 1 to Day 14 (EOS visit)
Incidence of SAEs (Part C)
Measured: From Day 1 to Day 31 (EOS visit)
Number of participants with abnormal vital signs (Part A)
Measured: Days 1,2,3,4,5,6,7 and Day 14 (EOS visit)
Number of participants with abnormal vital signs (Part B)
Measured: Days 1,2,3,4,5,6,7 and Day 14 (EOS visit)
Number of participants with abnormal vital signs (Part C)
Measured: From Day 1 to Day 31 (EOS visit)
Number of participants with abnormal Physical examination findings (Part A)
Measured: Day 1 and Day 14 (EOS visit)
Number of participants with abnormal Physical examination findings (Part B)
Measured: Day 1 and Day 14 (EOS visit)
Number of participants with abnormal Physical examination findings (part C)
Measured: Days 1, 11, 16 and Day 31 (EOS visit)
Number of participants with abnormal laboratory tests results (Part A)
Measured: Days 1,2 4,7 and Day 14 (EOS visit)
Number of participants with abnormal laboratory tests results (Part B)
Measured: Days 1,2 4,7 and Day 14 (EOS visit)
Number of participants with abnormal laboratory tests results (Part C)
Measured: Days 1,2,3,4,5,6,7,8,9,10,11,14,16 and Day 31 (EOS visit)
Number of participants with abnormal ECG readings (Part A)
Measured: Days 1,2,7 and Day 14 (EOS visit)
Number of participants with abnormal ECG readings (Part B)
Measured: Days 1,2,7 and Day 14 (EOS visit)
Number of participants with abnormal ECG readings (Part C)
Measured: Days 1, 11, 16 and Day 31 (EOS visit)
Secondary outcomes (14)
Plasma PK parameters- Cmax (Maximum observed plasma drug concentration) (Part A)
Measured: From Day 1 to Day 7
Plasma PK parameters- Cmax (Maximum observed plasma drug concentration) (Part B)
Measured: From Day 1 to Day 7
Plasma PK parameters- Tmax (Time to maximum observed plasma drug concentration) (Part A)
Measured: From Day 1 to Day 7
Plasma PK parameters- Tmax (Time to maximum observed plasma drug concentration) (Part B)
Measured: From Day 1 to Day 7
Plasma PK parameters-AUCt (Area under the plasma concentration-time curve, from time 0 to the last time point with measurable analyte concentration) (Part A)
Measured: From Day 1 to Day 7
Plasma PK parameters-AUCt (Area under the plasma concentration-time curve, from time 0 to the last time point with measurable analyte concentration) (Part B)
Measured: From Day 1 to Day 7
Plasma PK parameters- AUC∞ (Area under the plasma concentration-time curve from time 0 extrapolated to infinity) (Part A)
Measured: From Day 1 to Day 7
Plasma PK parameters- AUC∞ (Area under the plasma concentration-time curve from time 0 extrapolated to infinity) (Part B)
Measured: From Day 1 to Day 7
Plasma PK parameters- AUC%extrap (The percentage of the AUC that was extrapolated beyond the last observed data point) (Part A)
Measured: From Day 1 to Day 7
Plasma PK parameters- AUC%extrap (The percentage of the AUC that was extrapolated beyond the last observed data point) (Part B)
Measured: From Day 1 to Day 7
Plasma PK parameters- Cmin,ss (Observed minimum plasma drug concentration in the dosing interval at steady-state) (Part C)
Measured: From Day 1 to Day 31 (EOS visit)
Plasma PK parameters- Cavg (Average steady-state concentration) (Part C)
Measured: From Day 1 to Day 31 (EOS visit)
Plasma PK parameters- Tmin,ss (Time of minimum observed concentration at steady-state) (Part C)
Measured: From Day 1 to Day 31 (EOS visit)
Plasma PK parameters- AUCtau (Area under the plasma concentration-time curve over the dosing interval (12 hours) at steady-state) (Part C)
Measured: From Day 1 to Day 31 (EOS visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start20 Oct 2026 (estimated)
- Primary completion15 Mar 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focal Onset SeizureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Avata Biosciences Holdings Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Victor Wong, Dr., Principal investigator, Nucleus Network, NSW, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07918469
- Sponsor's protocol ID
- AVBIO-004-121
- Status last verified
- Nov 2026
- First submitted
- 1 Nov 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single Center, Open-Label, Single Ascending Dose and Multiple Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral Cannabidiol Capsules (AVAT-121) and Epidyolex® in Healthy Male and Female Adult Participants, Including Japanese Adults
- ClinicalTrials.gov ID
- NCT07918469
- Acronym / sponsor ID
- AVBIO-004-121
- Conditions
- Focal Onset Seizure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Avata Biosciences Holdings LtdIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2026 (estimated)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 5 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 1 study will evaluate the safety, tolerability, and pharmacokinetics of AVAT-121 in healthy adults.
The study includes three parts:
Part A: single ascending dose.
Part B: comparison of AVAT-121 with Epidyolex®, under fed and fasted conditions.
Part C: multiple-dose testing
Up to 44 participants will be enrolled in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A- Single ascending doses of AVAT-121. | Experimental | Drug: AVAT-121 |
| Part B - Relative Bioavailability and Food Effect Evaluation | Experimental | Drug: AVAT-121 and Epidyolex® |
| Part C - Multiple ascending doses of AVAT-121 | Experimental | Drug: AVAT-121 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Body mass index (BMI) between ≥ 18.0 and ≤ 32.0 kg/m2 and weight ≥ 60 kg
- Not pregnant or breastfeeding, or willing to cease breastfeeding
- Woman of childbearing potential (WOCBP) or fertile man agrees to use a male condom combined with a highly effective method of contraception from the start of Screening (hormonal contraceptives must have commenced at least 30 days prior to Screening) until 90 days after the last dose of IP.
- Adequate venous access in both arms.
- Japanese participants must be up to third generation Japanese lineage, which is defined as, the participant's, biological grandparents as 100% Japanese, and were all born in Japan. Non-Japanese participants must not meet these criteria.
Key exclusion criteria (9 listed)
- Any history or evidence of any clinically significant renal, hepatic, gastrointestinal (history of appendectomy is permitted), cardiovascular, respiratory (history of childhood asthma is permitted), hematologic, dermatologic (history of eczema is permitted provided there has been no use of topical steroid creams within 3 months prior to Screening), autoimmune, endocrine (history of fully resolved gestational diabetes is permitted), inflammatory, neurological, or any uncontrolled medical condition that, in the opinion of the PI or designee, could jeopardize the safety of the participant, prevent complete participation in the study, or compromise interpretation of study data.
- Any psychiatric condition requiring pharmacological management within 6 months prior to Screening, current or prior psychotic disorder, schizophrenia or bipolar disorders, or current suicidal ideation or behavior including a response of "Yes" to C-SSRS Questions 4 or 5, or any positive response to the suicidal behavior section of the C-SSRS.
- Participants with current or past history of acute or chronic liver disease of any etiology.
- Donation of plasma within 7 days prior to first administration of IP or donation or loss of 500 mL or more of whole blood within 30 days prior to first administration of IP.
- Fever (tympanic temperature > 38°C) or symptomatic viral or bacterial infection within 14 days prior to Screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AVAT-12112 participants will receive single ascending doses of AVAT-121 (200 mg, 400 mg, and 800 mg). Route of administration: Oral | Drug | Part A- Single ascending doses of AVAT-121. |
| AVAT-121 and Epidyolex®12 participants will receive single doses of 600 mg AVAT-121 and 600mg Epidyolex® under both fed and fasted conditions. Route of administration: Oral | Drug | Part B - Relative Bioavailability and Food Effect Evaluation |
| AVAT-12120 participants (12 non-Japanese and 8 Japanese) will receive AVAT-121 administered under fed conditions using a multiple-dose titration regimen of 200 mg twice daily for 2 days (400mg/day), followed by 400 mg twice daily for 2 days (800mg/day), followed by 600 mg twice daily for 6 days(1200mg/day). Route of administration: Oral | Drug | Part C - Multiple ascending doses of AVAT-121 |
Primary outcome
Incidence of TEAEs (Part A)
Time frame: From Day 1 to Day 14 (EOS visit)
Incidence of TEAEs (Part B)
Time frame: From Day 1 to Day 14 (EOS visit)
Incidence of TEAEs (Part C)
Time frame: From Day 1 to Day 31 (EOS visit)
Incidence of SAEs (Part A)
Time frame: From Day 1 to Day 14 (EOS visit)
Incidence of SAEs (Part B)
Time frame: From Day 1 to Day 14 (EOS visit)
Incidence of SAEs (Part C)
Time frame: From Day 1 to Day 31 (EOS visit)
Number of participants with abnormal vital signs (Part A)
Time frame: Days 1,2,3,4,5,6,7 and Day 14 (EOS visit)
Number of participants with abnormal vital signs (Part B)
Time frame: Days 1,2,3,4,5,6,7 and Day 14 (EOS visit)
Number of participants with abnormal vital signs (Part C)
Time frame: From Day 1 to Day 31 (EOS visit)
Number of participants with abnormal Physical examination findings (Part A)
Time frame: Day 1 and Day 14 (EOS visit)
Number of participants with abnormal Physical examination findings (Part B)
Time frame: Day 1 and Day 14 (EOS visit)
Number of participants with abnormal Physical examination findings (part C)
Time frame: Days 1, 11, 16 and Day 31 (EOS visit)
Number of participants with abnormal laboratory tests results (Part A)
Time frame: Days 1,2 4,7 and Day 14 (EOS visit)
Number of participants with abnormal laboratory tests results (Part B)
Time frame: Days 1,2 4,7 and Day 14 (EOS visit)
Number of participants with abnormal laboratory tests results (Part C)
Time frame: Days 1,2,3,4,5,6,7,8,9,10,11,14,16 and Day 31 (EOS visit)
Number of participants with abnormal ECG readings (Part A)
Time frame: Days 1,2,7 and Day 14 (EOS visit)
Number of participants with abnormal ECG readings (Part B)
Time frame: Days 1,2,7 and Day 14 (EOS visit)
Number of participants with abnormal ECG readings (Part C)
Time frame: Days 1, 11, 16 and Day 31 (EOS visit)
14 secondary outcomes
Plasma PK parameters- Cmax (Maximum observed plasma drug concentration) (Part A)
Time frame: From Day 1 to Day 7
Plasma PK parameters- Cmax (Maximum observed plasma drug concentration) (Part B)
Time frame: From Day 1 to Day 7
Plasma PK parameters- Tmax (Time to maximum observed plasma drug concentration) (Part A)
Time frame: From Day 1 to Day 7
Plasma PK parameters- Tmax (Time to maximum observed plasma drug concentration) (Part B)
Time frame: From Day 1 to Day 7
Plasma PK parameters-AUCt (Area under the plasma concentration-time curve, from time 0 to the last time point with measurable analyte concentration) (Part A)
Time frame: From Day 1 to Day 7
Plasma PK parameters-AUCt (Area under the plasma concentration-time curve, from time 0 to the last time point with measurable analyte concentration) (Part B)
Time frame: From Day 1 to Day 7
Plasma PK parameters- AUC∞ (Area under the plasma concentration-time curve from time 0 extrapolated to infinity) (Part A)
Time frame: From Day 1 to Day 7
Plasma PK parameters- AUC∞ (Area under the plasma concentration-time curve from time 0 extrapolated to infinity) (Part B)
Time frame: From Day 1 to Day 7
Plasma PK parameters- AUC%extrap (The percentage of the AUC that was extrapolated beyond the last observed data point) (Part A)
Time frame: From Day 1 to Day 7
Plasma PK parameters- AUC%extrap (The percentage of the AUC that was extrapolated beyond the last observed data point) (Part B)
Time frame: From Day 1 to Day 7
Plasma PK parameters- Cmin,ss (Observed minimum plasma drug concentration in the dosing interval at steady-state) (Part C)
Time frame: From Day 1 to Day 31 (EOS visit)
Plasma PK parameters- Cavg (Average steady-state concentration) (Part C)
Time frame: From Day 1 to Day 31 (EOS visit)
Plasma PK parameters- Tmin,ss (Time of minimum observed concentration at steady-state) (Part C)
Time frame: From Day 1 to Day 31 (EOS visit)
Plasma PK parameters- AUCtau (Area under the plasma concentration-time curve over the dosing interval (12 hours) at steady-state) (Part C)
Time frame: From Day 1 to Day 31 (EOS visit)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Victor Wong, Dr. principal investigator
Nucleus Network, NSW, Australia
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AVAT-121 and AVAT-121 and Epidyolex® in people with Focal Onset Seizure, run by Avata Biosciences Holdings Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pia Varsamis (+61 407 199 010, h.varsamis@nucleusnetwork.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of TEAEs (Part A) (time frame: From Day 1 to Day 14 (EOS visit)). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.