7. The
process of achieving Informed Consent from the participants.
Achieving informed consent is a process that begins when initial contact is
made with the prospective subjects and continues throughout the course of the
study. The investigator must put effort to improve the comprehension of the
prospective subjects. By informing them, by repetition and explanation, by
answering their questions as they arise, and by ensuring that each individual
understands each procedure, investigators obtain the informed consent of the
participants. In doing so, investigators manifest respect for the dignity and
autonomy of the participants. Each individual must be given as much time as is
needed to reach a decision, including time for consultation with family members
or others (Association of Clinical Research
Professionals, 2013). Prospective participants who are
vulnerable or lack decision making capacity must receive particular attention.
Subsequently, the investigator must assess the decision making capacity of the
prospective participant by employing, for instance, a questionnaire. Finally,
the prospective participant, the legal representative or consultee must be
allowed to make a free and voluntary decision to participate or withdraw by
minimizing possible coercion or undue influence. The informed consent is
formally sealed with the signature of the participant, the legal representative
or consultee and the researcher who carried out the process (Adom Agyeman
& Ofori-Asenso, 2017).

The
ethical issues when selecting human subjects for the Phase I study.
Phase I, or First-in-Human (FiH) trials, raise a couple of ethical issues. An
ethical standard is that clinical trials require to have a favourable
risk-to-benefit ratio. Participants also must be protected from excessive risks
and burdens. But, both of these standards may be difficult to assess and to
achieve in FiH trials. There are no widely accepted standards for judgments
concerning risk, benefit, and value in FiH trials. Also, the question of how to
conceptualize and compute benefit has been a subject of ethical debate for FiH
trials in particular where the chance of therapeutic benefit to participants is
very slim as they are being exposed to an uncertain and high level of risk. Then,
there is the question as to how to communicate accurate and meaningful
information about the uncertainty, risk of adverse events, and the very
meaningful informed consent process. The fact that FiH trials, involving new
medical products, often enrol participants with serious unmet needs,
complicates the process further (Chapman, 2011). The main purpose of
clinical trials is after all to ”study” new medical products in people.
Therefore, it is important for people who are considering participation in a
clinical trial to understand their role, as a ”subject of research” and not
as a patient  (FDA, n.d.).

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(Arrien Pharmaceuticals, 2017) (Centre Hospitalier Universitaire Vaudois,
2015)

·        
Unable to communicate or cooperate with the investigator.

·        
History or a positive test result for hepatitis B, C, or HIV infection.

·        
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.  

·        
Use of any medication in 2 weeks prior to study and
throughout study.

·        
Participation in another clinical trial within 30 days prior to the study.

·        
Smoked or used nicotine-containing products within 30 days prior to the study.

·        
Clinically significant abnormal finding on the physical exam, medical
history, ECG, or clinical laboratory results.

·        
Blood (500 mL) donation or haemorrhage during the
previous 3 months

·        
History of alcohol or drug abuse within the past 2 years.

·        
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
drug.

Exclusion Criteria:

 

·        
Results of liver function tests within normal range.

·        
Results of hematology tests within normal range.

·        
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.

·        
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
administration.

·        
Provided informed consent.

·        
Body Mass Index (BMI) between 19 and 30 kg/m2.

·        
Aged between 18 to 55 years.

Inclusion Criteria:

Cohorts:
Group 1:              12 active + 4 placebo
Group 2:              12 active + 4
placebo
Group 3:              12 active + 4
placebo
Group 4:              12 active + 4
placebo

Subjects must
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).  

3. The
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 us 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,
2009).

The aim of Phase
I clinical trials are to determine the safety, tolerability and
pharmacokinetics of a compound.

 

B1 Clinical Development:
Phase I & GCP