A 3-part study in healthy male volunteers to assess the safety and tolerability of the test medicine TQS-168 and how it is taken up by the body when given as single and multiple doses
- Conditions
- Safety and tolerability of the test medicine TQS-168Not Applicable
- Registration Number
- ISRCTN46651459
- Lead Sponsor
- Tranquis Therapeutics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 77
1. Healthy male subjects
2. Aged 18 to 55 years inclusive at the time of signing informed consent
3. Body mass index (BMI) of 18.0 to 32.0 kg/m² as measured at screening
4. Weight =55 kg at screening
5. Must be willing and able to communicate and participate in the whole study
6. Must provide written informed consent
1. Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1
2. Subjects who are, or are immediate family members of, a study site or sponsor employee
3. Parts 1 and 2 Only: Subjects who have previously been administered IMP in this study
4. Evidence of current SARS-CoV-2 infection
5. History of any drug or alcohol abuse in the past 2 years
6. Regular alcohol consumption >21 units per week (1 unit = pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method