B1 Clinical Development:
Phase I & GCP
The aim of Phase
I clinical trials are to determine the safety, tolerability and
pharmacokinetics of a compound.
characteristics of the study population.
A randomised, placebo-controlled, safety, tolerability, dose escalation,
pharmacokinetic study of various doses of subcutaneous SAL97 (anti-?4?1integrin)
will be conducted in 64 healthy male volunteers. We need healthy volunteers to
help us define the limits of ”normal”. Healthy volunteers can provide the
”cleanest” data. Using a patient can be difficult to separate the effects of
a study intervention from the effects caused by the disease or medications of
the patient. Healthy people can also tolerate adverse effects from the
experimental interventions more easily than patients can. The reason is because
drug toxicity can exacerbate the existing medical problems of patients (Dresser,
be aged between 18-55. The reason for choosing this age group is because people
can develop the disease at any age (Pietrangelo & Higuera, 2015). Due to safety
concerns, women are excluded from participation in this phase I trial. Lastly,
we do not make a distinction in ethnicity (Travis, 2004).
Group 1: 12 active + 4 placebo
Group 2: 12 active + 4
Group 3: 12 active + 4
Group 4: 12 active + 4
Aged between 18 to 55 years.
Body Mass Index (BMI) between 19 and 30 kg/m2.
Provided informed consent.
Subject is willing and able to remain in the study for the entire study
period and returns for an outpatient visit 7 days after study treatment
Vital signs of subject must be within the following ranges: heart rate:
40-100 beats per minute; systolic blood pressure: 90-145 mmHg; diastolic blood
pressure: 50-95 mmHg.
Results of hematology tests within normal range.
Results of liver function tests within normal range.
History of cardiac, immunologic, renal or any other major diseaes that would likely have
interfered with the absorption, disposition, metabolism, or excretion of the study
History of alcohol or drug abuse within the past 2 years.
Blood (500 mL) donation or haemorrhage during the
previous 3 months
Clinically significant abnormal finding on the physical exam, medical
history, ECG, or clinical laboratory results.
Smoked or used nicotine-containing products within 30 days prior to the study.
Participation in another clinical trial within 30 days prior to the study.
Use of any medication in 2 weeks prior to study and
Treatment in any drugs that are inhibitors of cytochrome P450 (CYP) enzymes
within 30 days prior to study and that may have an impact on the safety of the
subjects and validity of the study results.
History or a positive test result for hepatitis B, C, or HIV infection.
Unable to communicate or cooperate with the investigator.
(Arrien Pharmaceuticals, 2017) (Centre
Hospitalier Universitaire Vaudois, 2015)