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Trial registered on ANZCTR


Registration number
ACTRN12625000020482p
Ethics application status
Submitted, not yet approved
Date submitted
11/12/2024
Date registered
13/01/2025
Date last updated
13/01/2025
Date data sharing statement initially provided
13/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Study to Examine the Safety, Tolerability and Pharmacokinetics of ascending doses of KNX100 in healthy volunteers.
Scientific title
KTX-003: A Phase 1 Study evaluating the Safety, Tolerability and Pharmacokinetics of ascending doses of KNX100 in healthy young and elderly volunteers.
Secondary ID [1] 313503 0
Nil known
Universal Trial Number (UTN)
U1111-1316-2265
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Health 335932 0
Condition category
Condition code
Mental Health 332517 332517 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drug KNX-100, 30mg and 50mg oral capsules
Experimental: Group 1: 5 single ascending doses of KNX100: Day 1: 30mg twice daily (60mg), Day 2: 50mg twice daily (100mg), Day 3: 100mg once daily, Day 30: 80mg twice daily (160mg) and Day 31: 150mg once daily.
Group 2: 2 single ascending doses of KNX100: Day 1: 30mg twice daily (60mg) and Day 20: 80mg twice daily (160mg).
Description: The study will have 2 parts, Part A and Part B. The same set of participants will be involved in both parts. The participants will attend in the clinic and stay inpatient during the dosing. In part A inpatient period for Group 1 is 4 nights. On Days 1-3 the participants will be administered KNX100 oral capsules in ascending fashion starting from 30mg twice daily to 100mg once daily. In part A for Group 2 inpatient period is 2 nights. On Day 1 participants will be administered KNX100 oral capsules 30mg twice daily. There will be break between Part A and Part B to review safety and plasma concentration data of the participants prior to bringing the same set of participants to Part B of the study, The participants will also return to safety monitoring visit prior to start of the Part B. In Part B the inpatient period for Group 1 is 3 nights. On days 30 and 31 the participants will be administered KNX100 oral capsule in ascending fashion starting from 80mg twice daily to 150mg once daily. In Part B for Group 2 the inpatient period is 2 nights. On Day 30 the participants will be administered KNX100 oral capsule 80mg twice daily. The participants will be monitored for safety and return to a follow up visit 7 days after the last dose.
Intervention code [1] 330074 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340037 0
Safety and tolerability of ascending doses of KNX100 administered as a single dose once daily or twice daily.
Timepoint [1] 340037 0
TEAE/SAE reports from first dose up to follow up, change in laboratory testing and in clinical observations from baseline.
The participants will be monitored for above safety and tolerability assessments throughout their in-patient stay (Group 1: Part A: Days 1 to 4 and Part B: Days 30-32 and Group 2: Part A: Days 1 to 2 and Part B: Days 30 to 31) in the clinical unit, and will have a follow up outpatient visit a week after Part A and a week after Part B have completed.
Secondary outcome [1] 442787 0
The secondary objective is to determine the Pharmacokinetic (PK) profile of KNX100 following administration of ascending doses of KNX100 administered orally as a single dose once daily or twice daily.
Timepoint [1] 442787 0
PK samples will be collected pre-dose and up to 12h post-dose on dosing days. During the dosing days (Group 1: Days 1-3 and Days 30-31 and Group 2: Day 1 and Day 30) when the dose is administered twice daily, the PK samples are collected at following timepoints: pre-dose, 0.5h, 1h, 2h, 4h and 8h post dose. When the dose is administered once daily, the PK samples are collected at following timepoints: pre-dose, 0.25h, 0.5h, 1h, 2h, 4h and 8h and 12h post dose.

Eligibility
Key inclusion criteria
1. Healthy male and female volunteers greater than or equal to 18 and less than or equal to 64 years old (Group 1) and greater than or equal to 65 years old (Group 2) at Screening.
2. Ability to understand and provide written informed consent.
3. Body mass index within the range of 18-32 (inclusive).
4. Able and willing to comply with the requirements of the study and complete the full sequence of protocol related doses, procedures, and evaluations.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Clinically significant history or presence of significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, haematological, neurological, or psychiatric disorder making implementation of the protocol or interpretation of the study results difficult, or that would put participants at risk in the opinion of the Investigator. Any surgical or medical history which may significantly alter the absorption, metabolism, or elimination of drugs or constitute a risk when taking the study intervention; or interfering with the interpretation of data (e.g., gastric bypass, cyclical vomiting, etc.). This includes a history of lymphoma, leukemia, or any malignancy within 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
2. Any history or family history (first or second degree relative) of seizure disorder, febrile convulsions or any clinically significant abnormal EEG findings at Screening.
3. Any clinically significant medical history of closed head trauma.
4. Any history of anaphylaxis or other significant allergy.
5. Any current diagnosis or clinically significant medical history of psychiatric illness as diagnosed and documented by a medical practitioner and as defined by the American Psychiatric Association DSM-5 making implementation of the protocol or interpretation of the study results difficult, or that would put the participant at risk in the opinion of the Investigator.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
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
24/03/2025
Actual
Date of last participant enrolment
Anticipated
30/04/2025
Actual
Date of last data collection
Anticipated
4/06/2025
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 317950 0
Commercial sector/Industry
Name [1] 317950 0
Kinoxis Therapeutics Pty Ltd
Country [1] 317950 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Kinoxis Therapeutics Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 320287 0
None
Name [1] 320287 0
Address [1] 320287 0
Country [1] 320287 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316626 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 316626 0
https://www.alfredhealth.org.au/research/ethics-research-governance
Ethics committee country [1] 316626 0
Australia
Date submitted for ethics approval [1] 316626 0
09/12/2024
Approval date [1] 316626 0
Ethics approval number [1] 316626 0

Summary
Brief summary
This is Phase 1, single treatment, two-period (Part A and B), two-group (Group 1 and 2), open-label study of ascending doses of KNX100 administered to healthy volunteers once or twice daily. Up to 5 dose cohorts, ranging from 30mg twice daily (60mg) to 80 mg twice daily (160 mg) of KNX100 will be evaluated. Approximately 6 male and female adult healthy volunteers will be enrolled in Group 1, and approximately 6 elderly, male and female healthy volunteers, 65 years of age and over, will be enrolled in Group 2. The same set of participants will be involved in both parts A and B. The participants will attend in the clinic and stay inpatient during the dosing. In part A inpatient period for Group 1 is 4 nights and for Group 2 it is 2 nights. There will be approximately 3 weeks rest period between Part A and Part B. In Part B inpatient period for Group 1 is 3 nights and for Group 2 it is 2 nights.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138450 0
Dr Philip Ryan
Address 138450 0
Nucleus Network Melbourne, Level 5, Burnet Tower, 89 Commercial Rd, Melbourne, Victoria, 3004
Country 138450 0
Australia
Phone 138450 0
+61 03 8593 9801
Fax 138450 0
Email 138450 0
[email protected]
Contact person for public queries
Name 138451 0
Tiina Ahveninen
Address 138451 0
Kinoxis Therapeutics, Suite 201, 697 Burke Road, Camberwell, VIC 3124
Country 138451 0
Australia
Phone 138451 0
+61 1800 460 409
Fax 138451 0
Email 138451 0
[email protected]
Contact person for scientific queries
Name 138452 0
Tiina Ahveninen
Address 138452 0
Kinoxis Therapeutics, Suite 201, 697 Burke Road, Camberwell, VIC 3124
Country 138452 0
Australia
Phone 138452 0
+61 1800 460 409
Fax 138452 0
Email 138452 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.