| Eligibility |
Inclusion Criteria:
1. Male or female healthy volunteer.
2. Aged 18-65 years.
3. A body mass index (BMI; Quetelet index) in the range 18.0-30.9. Body Mass Index =
weight (kg)/(height[m]^2
4. Ability to understand the nature of the trial and any hazards of participating in it.
Ability to communicate satisfactorily with the investigator and to participate in, and
comply with the requirements of, the entire trial.
5. Willingness to give written consent to participate after reading the information and
consent form (ICF), and after having the opportunity to discuss the trial with the
investigator or their delegate.
6. Agree to follow the contraception requirements of the trial
7. Agree not to donate blood or blood products during the study and for up to 3 months
after the administration of the trial medication or until the final follow-up visit
(whichever is longer).
8. Registered with a General Practitioner (GP) in the United Kingdom.
9. Willingness to give written consent to have data entered into The Overvolunteering
Prevention System (TOPS).
Exclusion Criteria:
1. Woman who is pregnant or lactating, or pre-menopausal woman who is sexually active and
not using a reliable method of contraception.
2. Clinically relevant abnormal history, physical findings, ECG, or laboratory values at
the pre-trial screening assessment that could interfere with the objectives of the
trial or the safety of the volunteer.
3. Isolated bilirubin > 1.5 x upper limit of normal (ULN). Isolated bilirubin > 1.5 x ULN
is acceptable if bilirubin is fractionated and direct bilirubin is < 35% indicative of
Gilbert's syndrome.
4. Presence of acute or chronic illness or history of chronic illness sufficient to
invalidate the volunteer's participation in the trial or make it unnecessarily
hazardous.
5. Impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes
mellitus, coronary heart disease, allergic diseases such as asthma or atopic
dermatitis requiring medication, or history of any psychotic mental illness.
6. Presence or history of severe adverse reaction to any drug or a history of sensitivity
to any CBS001 excipient.
7. Use of a prescription medicine (except hormone contraceptives or hormone replacement
therapy [HRT] in women) during the 28 days before the (first) dose of trial
medication, or use of an over-the-counter medicine (except acetaminophen
[paracetamol], dietary supplement, or herbal remedy) including St John's Wort during
the 7 days before the (first) dose of trial medication.
8. Receipt of an investigational product (including prescription medicines) as part of
another clinical trial within the 3 months before [first] admission to this study; in
the follow-up period of another clinical trial at the time of screening for this
study.
9. Receipt of an approved or investigational biological product within the 12 months
before screening.
10. Receipt of a vaccination (except COVID-19 vaccine) within 28 days before (first) dose
of trial medication, or planned vaccination during the study.
11. Presence or history of drug or alcohol abuse, or intake of more than 14 units of
alcohol weekly, or more than 10 cigarettes or 6.25 g of tobacco daily.
12. Blood pressure and heart rate in supine position at the screening examination outside
the ranges: blood pressure 90-140 mm Hg systolic, 40-90 mm Hg diastolic; heart rate
40-100 beats/min. Repeat measurements are permitted if values are borderline (ie
values that are within 5 mm Hg for blood pressure or 5 beats/min for heart rate) or if
requested
13. Corrected QT interval (QTcF) value greater than 450 msec (men) or greater than 470
msec (women) measured on 12-lead ECG at the screening examination. Triplicate
measurements will be made, and a mean value used to determine eligibility. A repeat
(in triplicate) is also allowed on 1 occasion for determination of eligibility.
Participants can be included if the repeat value is within range or still borderline,
but deemed not clinically significant by the investigator.
14. Possibility that the volunteer will not cooperate with the requirements of the
protocol.
15. Evidence of drug abuse on urine testing.
16. Positive test for hepatitis B, hepatitis C (unless has received curative antiviral
treatment and has a negative polymerase chain reaction [PCR] for viral load) or HIV.
Loss of more than 400 mL blood during the 3 months before the study, eg as a blood
donor.
17. Objection by GP to volunteer entering study.
|
