Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000454370
Ethics application status
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Approved
Date submitted
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24/03/2026
Date registered
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10/04/2026
Date last updated
Help: Date last updated
10/04/2026
Date data sharing statement initially provided
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10/04/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Chir-110 in Healthy Adult Participants
Scientific title
A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Chir-110 in Healthy Adult Participants
Additional trial identifiers [1] 316858 0
Chir110-001
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Treatment-Resistant Depression 341232 0
Condition category
Condition code
Mental Health 337325 337325 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Chir-110 is an oral capsule formulation of esketamine hydrochloride. Each capsule contains 50 mg esketamine hydrochloride. Participants randomized to active treatment will receive a single oral dose of Chir-110 on Day 1 under direct medical supervision at the study site. Planned single ascending dose cohorts are 50 mg (1 capsule), 100 mg (2 capsules), and subsequent cohorts up to a planned maximum of 300 mg, with later dose levels determined by review of emerging safety, pharmacokinetic and pharmacodynamic data by the Safety Review Committee. Dose escalation may be modified, repeated, reduced, or increased above 300 mg if prespecified pharmacokinetic safety thresholds are not exceeded.
The intervention is delivered at a single clinical study site to healthy adult participants. Dosing occurs after eligibility reconfirmation and randomization. Participants fast for at least 10 hours before dosing and continue fasting until at least 4 hours after dosing. Fluids are restricted from 1 hour before until 1 hour after dosing, except for 240 mL water given with study drug. Participants remain at the site for a 12-hour post-dose confinement/observation period on Day 1. Trained clinical staff are present throughout confinement, and the investigator or designee is on site for dosing and for at least 6 hours post-dose.
The intervention schedule includes screening from Day -28 to Day -2, optional eligibility reconfirmation on Day -1, dosing on Day 1, and follow-up visits on Days 2, 4 and 7, with an additional Day 3 pharmacokinetic sampling visit at either the study site or a designated local pathology centre. The protocol includes intensive post-dose assessments to characterise safety, tolerability, pharmacokinetics and pharmacodynamics, including blood and urine pharmacokinetic sampling and pharmacodynamic questionnaires (DEQ and CADSS).
Each cohort includes 2 sentinel participants dosed first (1 active, 1 placebo), followed at least 48 hours later by the remaining participants if safety is acceptable. The Safety Review Committee reviews blinded safety, tolerability, pharmacokinetic and pharmacodynamic data after each cohort and may escalate, de-escalate, repeat, or stop dose progression according to prespecified rules.
Intervention adherence/fidelity is ensured by on-site administration under supervision, with dosing time recorded as the time all capsule(s) are swallowed. Fidelity is further supported through controlled fasting/fluid requirements, direct clinical observation during confinement, protocol-specified assessment windows, and drug accountability procedures managed by designated site/pharmacy staff. Safety monitoring includes adverse event review, physical examination, vital signs, ECGs, clinical laboratory testing, and suicidality assessment (C-SSRS).
Intervention code [1] 333559 0
Treatment: Drugs
Description of the comparator or control
Participants randomized to the control arm will receive a single oral dose of matching placebo capsule(s) on Day 1 under direct medical supervision at the study site. Placebo capsules are matched to Chir-110 in appearance, weight, and excipients, but contain no active pharmaceutical ingredient. The placebo treatment is an oral capsule containing only inactive ingredient: Microcrystalline Cellulose 102 BP (MCC), 50 mg per capsule, in an HPMC capsule shell.
Administration conditions are identical to the intervention arm. Participants will fast for at least 10 hours prior to dosing and for at least 4 hours post-dose, with fluids restricted from 1 hour before to 1 hour after dosing, except for 240 mL of water administered with study drug. Participants will remain under continuous clinical observation for 12 hours post-dose.
Participants will undergo the same study procedures and assessments as the active arm, including safety monitoring (adverse events, vital signs, ECGs, laboratory tests, and suicidality assessments), pharmacokinetic blood and urine sampling, and pharmacodynamic assessments. Follow-up visits will occur on Days 2, 3, 4, and 7.
Allocation to placebo occurs within each cohort, including sentinel dosing (1 active:1 placebo) followed by remaining participants after safety review. This ensures comparability of safety and pharmacokinetic outcomes between treatment groups.
Control group
Placebo

Outcomes
Primary outcome [1] 344832 0
To evaluate the safety and tolerability of Chir-110 following oral administration of single ascending doses in healthy adult participants - composite outcome.
Timepoint [1] 344832 0
Baseline, Day 1, 2, 3, 4, and 7 post dose administration,
Secondary outcome [1] 459485 0
To characterize the pharmacokinetics (PK) profile of Chir-110 (esketamine) and its primary metabolites norketamine, hydroxynorketamine and hydroxyketamine following single ascending oral doses in healthy adult participants - composite outcome
Timepoint [1] 459485 0
PK blood samples will be collected pre-dose (within 45 minutes prior to dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, and 144 hours post-dose. Urine PK samples will be collected pre-dose and over 0–2, 2–4, 4–8, 8–12, 12–24, and 24–48 hour intervals post-dose.
Secondary outcome [2] 459486 0
To characterize pharmacodynamic (PD) profile of Chir-110 following single ascending oral doses in healthy adult participants.
Timepoint [2] 459486 0
Baseline (pre-dose), Day 1, 2, 3 post dose administration
Secondary outcome [3] 460269 0
To characterize pharmacodynamic (PD) profile of Chir-110 following single ascending oral doses in healthy adult participants.
Timepoint [3] 460269 0
Baseline (pre-dose), Day 1, 2, 3 post dose administration

Eligibility
Key inclusion criteria
1. Male or female, non-smoker (no use of tobacco or nicotine products within 6 months prior to first dose)
2. Aged more than or equal to 18 and less than or equal to 55 years
3. BMI more than 18.0 and less than 32.0 kg/m2 and body weight more than or equal to 50.0 kg.
4. Participant is judged by the Investigator to be in generally good health on the basis of medical history, physical examination, or clinical laboratory results during the screening.
5. Pulse between 45 and 100 beats per minute (bpm) at screening (inclusive)
6. Seated systolic BP between 90 and 160 mmHg, diastolic BP between 50 and 95 mmHg inclusive, at screening. For the purpose of qualifying any given participant for study participation, out-of-range vital signs may be repeated once.
7. No known history or family history of schizophrenia or other psychotic illness; history or presence of severe personality disorder or other significant psychiatric history or mental illness (in the opinion the Investigator).
8. Must have hepatic and renal clinical laboratory test results (ALT, AST, total bilirubin and eGFR) within a laboratory defined normal range.
9. Must not be pregnant, breastfeeding (non-lactating), or planning pregnancy.
10. Female participants must have negative serum hCG pregnancy test at screening and negative urine test at check-in.
11. Females of childbearing potential who are sexually active with a non-sterile male partner (sterile male partners are defined as men vasectomised at least 6 months prior to the first study drug administration) must be willing to use one of the following acceptable contraceptive methods throughout the study and for at least 3 months after the last study drug administration:
a. Simultaneous use of intrauterine contraceptive device without hormone release system placed at least 4 weeks prior to the first study drug administration; or intrauterine contraceptive device with hormone release system placed at least 12 weeks prior to first study drug administration; or oral hormonal contraceptives (minimum 12 week use without issue), and a condom for the male partner.
12. Females of non-childbearing potential must be:
a. Post-menopausal (absence of menses for at least 12 months prior to the first study drug administration) with confirmation of the post menopausal status by documented FSH level more than or equal to 40 mIU/mL; or
b. Surgically sterile (complete hysterectomy or bilateral oophorectomy at least 3 months prior to the first study drug administration).
13. Female participants must be willing not to donate ova for 30 days after the last dose
14. All male participants (including men who have had a vasectomy) must agree to use a condom from the first dose and for 90 days after the last dose.
15. Male participants who are not vasectomised for at least 3 months prior to dosing and who are sexually active with a female partner of childbearing potential must be willing to use one of the following acceptable contraceptive methods from the first dose and for 90 days after the last dose:
a. Simultaneous use of condom and established use of oral, injected or implanted hormonal contraceptive or placement of intrauterine device (IUD) or intrauterine system (IUS) for the female partner;
16. Male participants must be willing not to donate sperm for 90 days after the last dose.
17. Willing and able to adhere to all study requirements, including willingness to remain in the study unit for the requested duration of the confinement period on Day 1 1.
18. Able to understand the study procedures and provide signed and dated participant informed consent form (PICF) to participate in the study prior to screening.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
1. History of any clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, or cardiovascular disease or other condition which would jeopardize safety or impact validity of results (in the opinion the Investigator).
2. History of severe allergic or anaphylactic reactions, known intolerance, allergy or hypersensitivity reactions to Esketamine
3. History of coronary disease, peripheral vascular disease, cerebrovascular accident, transient ischemic attack, uncontrolled hypertension or signs/symptoms of ischemic heart disease.
4. Participant has any documented history of, or currently active, seizure disorder or history of clinically significant head injury or history of intracerebral hemorrhage
5. Has undergone surgery requiring or has received (for any reason) anesthetic within 30 days of Day 1, or has planned surgery during the study
6. Participant has an active malignancy of any type or has been diagnosed with cancer within 5 years prior to screening (excluding squamous or basal cell carcinoma of the skin).
7. Any laboratory test results deemed clinically significant by the Investigator or positive test serology test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen and antibody at screening.
8. Clinically significant ECG abnormalities (Fridericia’s corrected QT interval [QTcF] more than 450 ms for males and more than more than 470 ms for females), PR more than 210 ms, QRS interval more than 120 ms at screening.
9. Clinically significant bradycardia or tachycardia defined as resting heart rate (HR) less than 40 bpm or more than 100 bpm, respectively.
10. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels more than 1.50 times the upper limit of normal at screening.
11. Positive urine drug screen, urine cotinine and urine alcohol test and at screening or check-in.
Testing for any out-of-range laboratory tests (ex.criteria # 8-11) values may be repeated once at the discretion of the Investigator.
12. Known allergic reactions to any excipient in the formulations.
13. History of significant drug abuse such as cocaine, phencyclidine (PCP), crack, opioid derivatives including heroin, and amphetamine derivatives within 1 year prior to screening.
14. Use of marijuana (directly or indirectly) within 90 days prior to drug administration and during the course of the study.
15. History of significant alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to the screening visit that exceeds 14 units of alcohol per week (1 unit equals 150 mL of wine, 375 mL of mid strength beer, or 30 mL of distilled alcohol 40%).
16. Use of medications for the timeframes specified below, with the exception of medications exempted by the Investigator on a case-by-case basis because they are judged unlikely to affect the PK profile of the study drug or participant safety (e.g., topical drug products without significant systemic absorption):
a. Prescription medications (except for non-hormonal contraceptives) within 14 days prior to the first dose until end of the study.
b. Monoamine oxidase inhibitors (MAOIs) within 28 days prior to dosing.
c. Over-the-counter products and natural health products (including herbal remedies such as St. John’s wort, homeopathic and traditional medicines), and antacid preparations within 14 days prior to the first dose up to end of study. Vitamins used as nutritional supplements in non-therapeutic doses (judged by the qualified Investigator or designee) may be accepted, but they must be stopped at least 48 hours before dosing and during the study.
d. Any drugs known to induce or inhibit hepatic and renal drug metabolism within 30 days prior to the first dose and during the study.
e. Any drugs that have a significant impact on the CNS including benzodiazepines (e.g., Diazepam, Alprazolam, Lorazepam), Antipsychotic medications (e.g., Haloperidol, Risperidone, Quetiapine), Antidepressants (e.g., Sertraline, Fluoxetine, Escitalopram), Antiepileptic drugs (e.g., Phenytoin, Carbamazepine, Valproate) or Sedative-hypnotics (e.g., Zolpidem, Zopiclone, Eszopiclone) within 30 days prior to the first dose and during the study.
f. Use of macrolide antibiotics (e.g., Erythromycin), azole antifungal agents (e.g., Ketoconazole) or protease inhibitors (e.g., Ritonavir) within 30 days of Day 1.
17. Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dose, administration of a biological product in the context of a clinical research study within 90 days prior to the first dose, or concomitant participation in an investigational study involving no drug or device administration.
18. Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or more of whole blood within 56 days prior to Day -1.
19. Any reason which, in the opinion of the Investigator, would compromise the participant from participating in the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central electronic randomisation system
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated randomisation sequence via an electronic randomisation system.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/04/2026
Actual
Date of last participant enrolment
Anticipated
31/03/2027
Actual
Date of last data collection
Anticipated
9/04/2027
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 321457 0
Commercial sector/Industry
Name [1] 321457 0
Chiral Biotech Pharma
Country [1] 321457 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Chiral Biotech Pharma
Address
Country
Australia
Secondary sponsor category [1] 324205 0
None
Name [1] 324205 0
Address [1] 324205 0
Country [1] 324205 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319991 0
Bellberry Human Research Ethics Committee D
Ethics committee address [1] 319991 0
Ethics committee country [1] 319991 0
Australia
Date submitted for ethics approval [1] 319991 0
23/07/2025
Approval date [1] 319991 0
23/03/2026
Ethics approval number [1] 319991 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 149066 0
Dr Sathyendran Sathi Seevanayagam
Address 149066 0
Vitalis Clinical Research Unit 15 456 St Kilda Rd, Melbourne VIC 3004
Country 149066 0
Australia
Phone 149066 0
+610418600016
Fax 149066 0
Email 149066 0
[email protected]
Contact person for public queries
Name 149067 0
Darryl Davies
Address 149067 0
iNGENu CRO, Unit 22/456 St Kilda Rd, Melbourne VIC 3004
Country 149067 0
Australia
Phone 149067 0
+61 1300 030 380
Fax 149067 0
Email 149067 0
[email protected]
Contact person for scientific queries
Name 149068 0
Darryl Davies
Address 149068 0
iNGENu CRO, Unit 22/456 St Kilda Rd, Melbourne VIC 3004
Country 149068 0
Australia
Phone 149068 0
+61 1300 030 380
Fax 149068 0
Email 149068 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.