A Phase 1 interventional study of AVAT-121 and AVAT-121 and Epidyolex® in Focal Onset Seizure, sponsored by Avata Biosciences Holdings Ltd. Not yet recruiting. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Avata Biosciences Holdings Ltd · Phase 1, Interventional, and Treatment
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.
766 studies on the registry are indexed under Seizures; 136 are open to participants now.
This study's planned enrollment of 44 is below the median of 64 across 519 interventional studies indexed under Seizures.
Browse Seizures studies →This is the only study on the registry with Avata Biosciences Holdings Ltd as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Inclusion Criteria Specific to Part C:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: AVAT-121
Drug: AVAT-121 and Epidyolex®
Drug: AVAT-121
12 participants will receive single ascending doses of AVAT-121 (200 mg, 400 mg, and 800 mg). Route of administration: Oral
12 participants will receive single doses of 600 mg AVAT-121 and 600mg Epidyolex® under both fed and fasted conditions. Route of administration: Oral
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
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)
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)
No study locations are listed for this record.
Start is estimated for Oct 2026; primary completion for Mar 2027, 4 months later.
Of 16 phase 1 interventional studies under Seizures, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 56. This study's planned 4 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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