Study of CT001 in Healthy Volunteers

• Status: Completed
• Trial end date: 2021-06-02
• Target enrollment: 0
• Participant gender: Male

Summary

A phase 1, three arms, cross over comparison study to evaluate bioavailability, pharmacokinetics and safety of intra nasal CT001 in healthy volunteers.

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

Details

• Lead Sponsor: Cessatech A/S
• Collaborators: Dantrials Aps; Smerud Medical Research International AS
• Treatments: Ketamine; Sufentanil

Criteria

Inclusion Criteria:

• Age from 18 up to 55 years

• Non-smokers

• Body mass index (BMI) from 18.5 kg/m2 up to 30 kg/m2 v) Categorized as American Society of Anesthesiologists (ASA)

• Physical Status Class 1 or 2

• Clinically normal medical history, physical findings, vital signs, ECG and laboratory values.

Exclusion Criteria:

• Mental illness

• Opioid Risk Tool score of >3

• Pain Catastrophizing Scale score, total points >30

• Hospital Anxiety and Depression Scale (HADS), points ≥11 for anxiety or ≥11 points for depression

• Daily intake of analgesics

• History of alcohol or drug abuse or use of illicit drugs.

• Use of prescription drugs within 14 days or over-the-counter drugs 24 hours (intranasal medication 48 hours) prior to the first dose of study medication.

• Participant showing abnormal nasal cavity/airway

• History or presence of allergy to the study drug or drugs of this class, or a history of drug or other allergy.

• Positive tests for HIV, hepatitis B and hepatitis C

• Positive COVID-19 test or clinical symptoms of COVID-19

• Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 30 days of signing the informed consent for this trial

• Blood donation within 4 weeks prior to the first dosing visit