A Phase 1, Two Part Study Investigating the Safety, Tolerability and Pharmacokinetics of KNX100 in Healthy Volunteers

• Status: Not yet recruiting
• Trial end date: 2022-09-15
• Target enrollment: 0
• Participant gender: All

Summary

The primary objectives of this study are to evaluate the safety and tolerability of KNX100 administered orally as a single ascending dose and as multiple ascending doses in healthy volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Kinoxis Therapeutics Pty Ltd
• Collaborator: National Institute on Drug Abuse (NIDA)

Criteria

Inclusion Criteria:

1. Healthy male and female volunteers ≥ 18 years old.

2. If female, must be postmenopausal, surgically sterilized, or willing and able to use 2 methods of contraception throughout the study and for one month after the final follow up visit (2 months after the last dose).

3. Able to comply with the requirements of the study and complete the full sequence of protocol related doses, procedures, and evaluations.

4. Willing to agree not to use alcohol, tobacco, or recreational drugs and willing to have drug toxicity at screening, prior to the first dose of KNX100 and if drug use is suspected while active in the study.

5. Willing to discontinue use of nutritional supplements at the screening visit and throughout the study (multivitamin is allowed).

6. Ability to understand and provide written informed consent.

7. BMI within the range of 18-30 (inclusive).

Exclusion Criteria:

1. Clinically significant undercurrent illness or medical condition (including mental illness, suicide attempt, HIV infection, hepatitis), seizures, cardiovascular disease, including a history of syncope (fainting), unstable or low blood pressure readings, malignancy, or a medical history that would jeopardize the safety of the subject, limit participation or compromise the interpretation of the safety data derived from the subject.

2. Clinically significant findings on the screening or Day -1 ECG or physical examination, including QTcF duration >450 ms for males and >470 ms for females on ECG.

3. Clinically significant abnormalities on the screening or Day -1 laboratory findings.

4. Any history of meningitis, septicemia, or pneumonia.

5. Any history or family history (first or second degree relative) of seizure disorder or closed head trauma.

6. Any history of alcohol use disorder or substance use disorder.

7. Clinically significant 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.

8. 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.

9. Females who are pregnant (positive pregnancy test at screening or prior to first dose), lactating or unable / unwilling to use 2 methods of contraception throughout the study.