BEN8744 - First doses in humans
- Conditions
- Healthy volunteers. Ulcerative colitis (UC).Digestive System
- Registration Number
- ISRCTN57043417
- Lead Sponsor
- BenevolentAI Cambridge Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 76
1. Aged 18–65 years
2. Body mass index 18.0–30.9 kg/m2
3. In good health, as judged by medical history, medical examination, vital signs, ECG and clinical laboratory tests
4. Able to communicate with study personnel
5. Reliable, willing, and likely to comply with the protocol
6. Willing to comply with the contraception of the protocol
7. Consent to our informing their GP of their participation in the study, and to our entering their details into the over-volunteering database (TOPS)
1. Not healthy (clinically significant abnormality in our screening tests, which include ECG, vital signs, physical examination, and laboratory safety tests of blood and urine);
2. Abuse of alcohol or drugs
3. Taken prescription medicine or a COVID-19 vaccine during the 28 days before dosing; taken other medicine (except up to 2 g paracetamol), herbal remedies or dietary supplements during the 7 days before dosing; have had a serious reaction to any medicine
4. Have had any condition or operation that might affect the way the body absorbs medicines or have had any clinically significant disease
5. History of seizures or at risk of seizure (eg history of significant head trauma)
6. Significant suicidality history or suicidality risk (assessed by C-SSRS)
7. Objection by GP on medical grounds — because they might increase the risk, or confound the assessment of BEN8744. Mental illness might compromise consent.
8. Pregnant or breastfeeding or unwilling to comply with the contraception requirements of the protocol — because of the potential risk to the unborn or breastfed baby
9. Have donated blood, or taken part in another study, within the past 3 months or don't agree not to donate blood, or take part in another study, during the 3 months after this study
10. Regular users of cigarettes or tobacco and/or nicotine-containing products (including e-cigarettes) in the 3 months before screening. Social smokers or vapers who smoke/vape in the 1 month before screening.
11. Unwilling to eat a high-fat breakfast containing bacon — because, to study the effects of food on blood levels of the study medicine, we must give all participants the standard high-fat breakfast specified by the US Food and Drug Administration (Part B only)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method