Healthy volunteers. Ulcerative colitis (UC). Digestive System
Conditions
Interventions
The study is in 3 parts: Part A (single doses), Part B (food effect) and Part C (repeated doses).
In Part A, up to 64 participants will be enrolled, in 6 groups of 8 (called Groups A1–A6) and 2 opti
we plan to increase the dose as the study progresses. We plan to give the following doses:
1. Group A1: 2 mg
2. Group A2: 6 mg
3. Group A3: 20 mg
4. Group A4: 40 mg
5. Group A5: 80 mg
6. Group A6:
Sponsors
BenevolentAI Cambridge Ltd
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Safety and tolerability (Parts A and C): safety and tolerability of BEN8744, will be measured by standard Phase I unit monitoring. 1.1. Vital signs (blood pressure, pulse rate, tympanic temperature, and respiratory rate), 12-lead electrocardiogram (ECG), cardiac telemetry (Part A only), physical examination, laboratory safety tests (haematology, clinical chemistry, and urinalysis), and adverse events will be measured at screening, before dosing, at regular intervals up to 72 h after dosing and at the final follow-up visit 1.2. Observer's Assessment of Alertness/Sedation scale (OAAS/S), visual analogue scale (VAS) to monitor sedation will be measured before dosing, and at regular intervals after dosing 1.33. Columbia-Suicide Severity Rating Scale (C-SSRS) will be measured at screening, at 72 h after last dose and at the final follow-up visit (Part C only) 2. Pharmacokinetic parameters (Part B): plasma pharmacokinetic parameters of BEN8744 will be measured by solid phase extraction and liquid chromatography with tandem mass spectrometry before dosing, and at regular intervals up to 72 h after dosing in each treatment session. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pharmacokinetic parameters (Parts A and C): Plasma pharmacokinetic parameters of BEN8744 will be measured by solid phase extraction and liquid chromatography with tandem mass spectrometry before dosing and frequently up to 72 h after dosing. 2. Safety and tolerability (Part B): Safety and tolerability of BEN8744 will be measured by standard Phase I unit monitoring 2.1. Vital signs (blood pressure, pulse rate, tympanic temperature, and respiratory rate), 12-lead ECG, physical examination, laboratory safety tests (haematology, clinical chemistry, and urinalysis), and adverse events will be measured at screening, before dosing, at regular intervals up to 72 h after dosing in each treatment session and at the final follow-up visit 2.2. OAAS/S and VAS to monitor sedation will be measured before dosing, and at regular intervals up to 72 h after dosing in each treatment session | — |
Countries
England, United Kingdom
Outcome results
None listed