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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04901078




Registration number
NCT04901078
Ethics application status
Date submitted
9/05/2021
Date registered
25/05/2021

Titles & IDs
Public title
A Phase 1 Study Investigating the Safety, Tolerability and Pharmacokinetics of KNX100 in Healthy Volunteers
Scientific title
A Phase 1 Study Investigating the Safety, Tolerability and Pharmacokinetics of KNX100 in Healthy Volunteers
Secondary ID [1] 0 0
1UG3DA048743-01
Secondary ID [2] 0 0
KTX101
Universal Trial Number (UTN)
Trial acronym
KTX101
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteer Study 0 0
Opioid-use Disorder 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - KNX100

Experimental: Active - KNX100 which will be provided in capsule form as 5, 25 and 100 mg capsules for oral administration. Study drug will be encapsulated in hydroxypropyl methylcellulose (HPMC) dark green opaque size 0 capsules and packaged in 100 mL high density polyethylene (HDPE) bottles with polypropylene (PP) twist-off closures.

Placebo comparator: Placebo - KNX100 matching placebo will be provided in capsule form for oral administration. The placebo will be encapsulated in HPMC dark green opaque size 0 capsules and packaged in 100 mL HDPE bottles with PP twist-off closures.


Treatment: Drugs: KNX100
KNX100 will be provided in capsule form as 5, 25 and 100 mg capsules for oral administration. Study drug will be encapsulated in hydroxypropyl methylcellulose (HPMC) dark green opaque size 0 capsules and packaged in 100 mL high density polyethylene (HDPE) bottles with polypropylene (PP) twist-off closures.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from Baseline to safety parameters
Timepoint [1] 0 0
From Time of Consent to Follow Up Visit (38 days)
Primary outcome [2] 0 0
Change from Baseline to safety parameters
Timepoint [2] 0 0
From Time of Consent to Follow Up Visit (44 days)
Secondary outcome [1] 0 0
Proportion of Treatment Emergent Adverse Events (TEAE's) in subjects treated with KNX100 as compared to placebo
Timepoint [1] 0 0
From Time of Consent to Follow Up Visit (38 and 44 days)
Secondary outcome [2] 0 0
Pharmacokinetics properties of KNX100
Timepoint [2] 0 0
From Time of Consent to Follow Up Visit (38 and 44 days)
Secondary outcome [3] 0 0
Pharmacokinetics properties of KNX100
Timepoint [3] 0 0
From Time of Consent to Follow Up Visit (38 and 44 days)
Secondary outcome [4] 0 0
Pharmacokinetics properties of KNX100
Timepoint [4] 0 0
From Time of Consent to Follow Up Visit (38 and 44 days)
Secondary outcome [5] 0 0
Proportion of Treatment Emergent Adverse Events (TEAE's) in subjects treated with KNX100 as compared to placebo
Timepoint [5] 0 0
From Time of Consent to Follow Up Visit (38 and 44 days)

Eligibility
Key inclusion criteria
1. Ability to understand and provide written informed consent.
2. Body mass index (BMI) within the range of 18-32 (inclusive).
3. Healthy male and female volunteers =18 and =55 years old at Screening.
4. Able and willing to comply with the requirements of the study and complete the full sequence of protocol related doses, procedures, and evaluations.
5. Willing to agree not to use alcohol or recreational drugs and willing to have drug screening, prior to the first dose of KNX100 and if drug use is suspected while active in the study.
6. Willing to agree not to smoke cigarettes or use tobacco based products prior to the first dose of KNX100 and for the entire duration of the study.
7. Males who are sexually active must use a condom OR be abstinent OR have the same sex partner OR be surgically sterile OR have partner who is of non-childbearing potential, for at least 90 days after the last dose of investigational drug. If female partner is a Woman of Child-Bearing Potential (WOCBP), the female partner must use highly effective methods of contraception, defined as below:

* Hormonal methods of contraception including oral contraceptives containing combined estrogen and progesterone, a vaginal ring, injectable and implantable hormonal contraceptives, intrauterine hormone-releasing system (e.g., Mirena) and progestogen-only hormonal contraception associated with inhibition of ovulation.
* Nonhormonal intrauterine device,
* Bilateral tubal occlusion.
Minimum age
18 Years
Maximum age
55 Years
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, hematological, neurological, or psychiatric disorder. 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. Subjects who have a sitting or semi-supine blood pressure at screening or Day-1, after resting for at least 3 minutes of systolic blood pressure >140 or <100 mmHg, or diastolic blood pressure >90 or <60 mmHg.
3. Subjects who have a sitting or semi-supine pulse rate at screening or Day-1, after resting for at least 3 minutes, outside the range of <50 or >90 beats/minute
4. Subjects who donated blood or who had a comparable blood loss (approximately 500 mL) during the last 30 days prior to start of this study and while on study.
5. Clinically significant findings on the screening, Day -1, or predose Day 1 electrocardiogram (ECG) or physical examination, including QTcF duration >450 ms for males and >470 ms for females on ECG.
6. Thyroid function tests outside the normal reference ranges and deemed clinically significant by the study PI (and upon repeat).
7. Safety laboratory tests that are outside the normal reference ranges and deemed clinically significant by the study PI (and upon repeat).
8. Any history of meningitis, septicemia, or pneumonia.
9. Any history or family history (first or second degree relative) of seizure disorder, febrile convulsions.
10. Any clinically significant medical history of closed head trauma.
11. Any history of anaphylaxis or other significant allergy.
12. 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 Diagnostic and statistical manual of mental disorders 5th edition (DSM-5).
13. Subjects with a history of chronic alcohol (regular daily intake of more than three standard drinks) or drug abuse within the last 6 months prior to first administration, or evidence of such abuse as indicated by the laboratory profile conducted during the screening examination.
14. Subjects who have received prescription drugs or over-the-counter (OTC) medication including dietary supplements, COVID-19 vaccine, standard dose vitamins, or herbal products within 14 days prior to the first administration (with the exception of the oral contraceptive pill).
15. Subjects who received any treatment agents known to alter the major organs or systems within 30 days prior to the first administration (e.g., diuretics, nephro- or liver toxic medication, barbiturates, phenothiazines, cimetidine, more than 1.0 L of caffeine-containing beverages per day, etc.).
16. Diagnosed infection of any kind, e.g., viral, bacterial, fungal, or mycobacterial within 1 month prior to the first dose of KNX100 or current fever or clinical signs or symptoms of infection at screening or Day -1.
17. Treatment with an unapproved investigational therapeutic agent within 30 days (or 5 half-lives for small molecule agents) prior to the first dose of KNX100.
18. Females who are pregnant (positive pregnancy test at screening or prior to first dose), lactating or unable/unwilling to use defined methods of contraception throughout 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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/09/2023
Sample size
Target
Accrual to date
Final
64
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Kinoxis Therapeutics Pty Ltd
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Institute on Drug Abuse (NIDA)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Tina Soulis, PhD
Address 0 0
Kinoxis Therapeutics Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04901078