AB103 Peptide Antagonist in Healthy Volunteers

• Sponsor: Atox Bio Ltd (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01166984
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Arms: 5
• Duration (Months): 9
• Patients Per Site Per Month: 2.8

Study Details

Study Description

Brief Summary

The primary objective of this study is to establish the safety profile and maximum tolerated dose (MTD) of AB103 given as a single intravenous (IV) infusion in healthy volunteers.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteer Safety Study	Drug: AB103; Drug: Placebo	Phase 1

Detailed Description

After consent and establishing eligibility for the study, each subject received a single IV infusion of escalating doses of AB103 (7.5, 37.5, 150, 450 μg/kg in 5 subjects at each dose) or placebo (n=5). Screening blood chemistry, hematology, coagulation, urinalysis, vital signs, and electrocardiogram (ECG) were used to assure medical fitness to participate in the study. These measures were repeated during and after treatment with AB103 to monitor for adverse events (AEs). ECG and pulse oximetry was monitored continuously starting 15 minutes before the infusion and for 2 hours after each infusion. Vital signs (sitting blood pressure, temperature, heart rate, respiratory rate, and pulse oximetry) and ECG measurements were recorded every 15 minutes for the first two hours starting from the beginning of the infusion and then approximately 24 hours later. Blood chemistry, hematology, coagulation, and urinalysis, were repeated one day and one week after infusions. AEs either observed by the investigator or reported spontaneously by the subjects were recorded at each study visit. Subjects kept a 7-day diary starting on the day of infusion to record any AEs. The primary basis on which escalation was based was dose limiting toxicities (DLTs) defined as the emergence of one or more selected AEs that reached a threshold which justified stopping the trial. After safety monitoring committee review of safety data, progression to the next cohort was to occur as follows:

1. If none of the 5 AB103 subjects in a cohort experienced a non-extreme DLT, escalation to the next dose cohort was to occur.

2. If 1 of 5 subjects receiving AB103 in a cohort experienced a non-extreme DLT, then a total of 8 subjects (6 active: 2 placebo) were to be enrolled in that cohort before escalating to the next dose (escalation will only occur if no additional subjects (2 total) have a non-extreme DLT).

3. If there were 0/6 or 1/6 active subjects with a non-extreme DLT at the highest dose, the highest dose was to be considered the MTD. If there were 2/6 active subjects with a non-extreme DLT in a cohort, then the next lowest dose was to be considered the MTD.

4. If an extreme DLT occurred, the study was to be halted immediately.

Subjects in Cohorts #1 to #3 had a blood sample (40 milliliters, mL) drawn pre-infusion, 24 hours after the infusion (Day 2), and a final sample at the Day 6-8 clinic visit (total of 120 mL) for leukocyte phenotyping by flow cytometry. Subjects in Cohort #4 had a blood sample (40 mL) drawn pre-infusion, 1 hour after the infusion, and a final sample at the Day 6-8 clinic visit (total of 120 mL) for leukocyte phenotyping by flow cytometry.

For the pharmacokinetic (PK) analysis, blood was collected at the mid-point of the infusion and 1, 2, 5, 10, 20, 30, and 60 minutes and approximately 24 hours post-infusion, and plasma was isolated for quantitation of AB103 peptide concentrations.

Study Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Phase 1, Double Blind, Placebo-Controlled, Dose Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Clinical Trial of AB103, A Peptide Antagonist in Healthy Volunteers
• Study Start Date: Sep 1, 2010
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AB103 7.5 µg/kg AB103 7.5 µg/kg administered as a single IV infusion	Drug: AB103; Single intravenous infusion at doses of 7.5 µg/kg, 37.5 µg/kg, 150 µg/kg, or 450 µg/kg administered over approximately 10 minutes
Experimental: AB103 37.5 µg/kg AB103 37.5 µg/kg administered as a single IV infusion	Drug: AB103; Single intravenous infusion at doses of 7.5 µg/kg, 37.5 µg/kg, 150 µg/kg, or 450 µg/kg administered over approximately 10 minutes
Experimental: AB103 150 µg/kg AB103 150 µg/kg administered as a single IV infusion	Drug: AB103; Single intravenous infusion at doses of 7.5 µg/kg, 37.5 µg/kg, 150 µg/kg, or 450 µg/kg administered over approximately 10 minutes
Experimental: AB103 450 µg/kg AB103 450 µg/kg administered as a single IV infusion	Drug: AB103; Single intravenous infusion at doses of 7.5 µg/kg, 37.5 µg/kg, 150 µg/kg, or 450 µg/kg administered over approximately 10 minutes
Placebo Comparator: Placebo Normal saline (0.9% sodium chloride) administered as a single IV infusion	Drug: Placebo; Single intravenous infusion of normal saline (0.9% sodium chloride) administered over approximately 10 minutes

Outcome Measures

Primary Outcome Measures

1. Number Adverse Events (AEs) [2 weeks]

   An AE is any untoward medical occurrence in a subject administered study drug and that does not necessarily have a causal relationship with the study drug. An AE could therefore be any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the study drug.

2. Number of Serious Adverse Events (SAEs) [2 weeks]

   A serious adverse event (SAE) is an AE occurring during any study phase and at any dose of the study drug (AB103 or placebo) that fulfills one or more of the following criteria: Results in death Is life-threatening (i.e., the subject was, in the opinion of the Investigator, at immediate risk of death from the event as it occurred) Requires or prolongs hospitalization Results in persistent or significant disability or incapacity (i.e., the event causes a substantial disruption of a person's ability to conduct normal life functions) Is a congenital anomaly or birth defect, or Is an important and significant medical event.

3. Number of Dose-limiting Toxicities (DLTs) [2 weeks]

   DLTs were defined as the emergence of one or more selected AEs that reached a threshold that may justify stopping the trial.

Secondary Outcome Measures

1. Area Under the Plasma Concentration-time Curve (AUC) [Whole blood was collected pre-dose; at the mid-point of the infusion; at 1, 2, 5, 10, 20, 30, and 60 minutes post-infusion; and at approximately 24 hours post-infusion for the measurement of AB103 plasma concentrations.]

   Area under the plasma concentration-time curve (AUC) from time zero to infinity following a single dose of study drug, obtained via noncompartmental methods. It is an integrated measure of study drug plasma exposure.

2. Cmax [Whole blood was collected pre-dose; at the mid-point of the infusion; at 1, 2, 5, 10, 20, 30, and 60 minutes post-infusion; and at approximately 24 hours post-infusion for the measurement of AB103 plasma concentrations.]

   Maximum plasma concentration

3. Apparent Terminal Plasma Half-life (T1/2) [Whole blood was collected pre-dose; at the mid-point of the infusion; at 1, 2, 5, 10, 20, 30, and 60 minutes post-infusion; and at approximately 24 hours post-infusion for the measurement of AB103 plasma concentrations.]

   Apparent terminal plasma half-life (T1/2) is the amount of time for plasma concentrations to decline by 50%.

4. Clearance (CL) [Whole blood was collected pre-dose; at the mid-point of the infusion; at 1, 2, 5, 10, 20, 30, and 60 minutes post-infusion; and at approximately 24 hours post-infusion for the measurement of AB103 plasma concentrations.]

   Clearance (CL) is the volume of plasma completely cleared of drug per unit of time.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Be able to read, understand and sign the Informed Consent form and be willing to participate in all study procedures for the duration of the study.

• Be 18-to-40 years-of-age.

• Have adequate venous access.

• Have a body mass index between 20 and 29 kg/m2.

• Have a history and physical examination that demonstrate no clinically significant contraindication for participating in the study, in the judgment of the admitting physician and/or the site investigator.

• Have vital signs as follows: resting heart rate between 50 and 90 beats per minute (bpm), systolic blood pressure (BP) below 150 mm Hg and diastolic BP below 90 mm Hg.

• Have all blood chemistry, hematology, coagulation, and urinalysis analyte levels within 10% of normal laboratory limits.

• If female, not be pregnant or breast-feeding, nor plan to become pregnant for the duration of the study, have a negative pregnancy test.

• Agree to exercise adequate birth control from the time of the screening procedures to 14 days after the investigational agent administration (both males and females).

• Have an electrocardiogram (ECG) performed that demonstrates normal sinus rhythm, normal conductivity, and no clinically significant arrhythmias.

Exclusion Criteria:

• Be pregnant or lactating.

• Have autoimmune disease or asthma.

• Have been febrile within 3-days of the first infusion.

• Have a history of migraine headaches, as diagnosed by a physician.

• Have any acute or chronic medical illnesses or other condition that, in the opinion of the Investigator, might jeopardize the safety of the patient, or the adequate evaluation of study results.

• Be taking any medications to treat a chronic medical condition.

• Have participated in a research study where they received any experimental products within 30 days prior to study entry.

• Have ongoing drug abuse/dependence (including alcohol) by medical history.

• Have taken, within 14 days of planned dosing, any prescription or non-prescription medication (including ibuprofen, aspirin, of non-steroidal anti-inflammatory drugs) unless the Principal Investigator/Sub-Investigator, in consultation with the Medical Monitor, provides a statement justifying that the medication taken will not impact the results of this study (with rare exceptions taking prescription drugs will be grounds for exclusion).

• Have donated a unit of blood within the preceding 4-week period.

• Have allergy to either sulfa- or penicillin-based drugs.

• Have a history of vagal responses resulting in bradycardia.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Maryland School of Medicine	Baltimore	Maryland	United States	21201

Sponsors and Collaborators

• Atox Bio Ltd

Investigators

• Principal Investigator: Alan Cross, MD, University of Maryland, College Park

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Atox Bio Ltd
• ClinicalTrials.gov Identifier: NCT01166984
• Other Study ID Numbers: ATB-001
• First Posted: Jul 21, 2010
• Last Update Posted: Jun 9, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Atox Bio Ltd: sepsis; septic shock

Study Results

Participant Flow

Recruitment Details	Subjects were recruited at the University of Maryland School of Medicine starting 7 September 2010. The study concluded 10 April 2011.
Pre-assignment Detail	One consented and screened subject found to be eligible was not randomized into the study because the target number of subjects had already been achieved.

Arm/Group Title	AB103 7.5 µg/kg	AB103 37.5 µg/kg	AB103 150 µg/kg	AB103 450 µg/kg	Placebo
Arm/Group Description	AB103 7.5 µg/kg single IV infusion	AB103 37.5 µg/kg single IV infusion	AB103 150 µg/kg single IV infusion	AB103 450 µg/kg single IV infusion	Normal saline (0.9% sodium chloride) single IV infusion
Period Title: Overall Study
STARTED	5	5	5	5	5
COMPLETED	5	5	5	5	5
NOT COMPLETED	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	AB103 7.5 µg/kg	AB103 37.5 µg/kg	AB103 150 µg/kg	AB103 450 µg/kg	Placebo	Total
Arm/Group Description	AB103 7.5 µg/kg administered as a single IV infusion	AB103 37.5 µg/kg administered as a single IV infusion	AB103 150 µg/kg administered as a single IV infusion	AB103 450 µg/kg administered as a single IV infusion	Normal saline (0.9% sodium chloride) administered as a single IV infusion	Total of all reporting groups
Overall Participants	5	5	5	5	5	25
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	5 100%	5 100%	5 100%	5 100%	5 100%	25 100%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	28 (7)	29 (6)	34 (5)	30 (4)	30 (8)	30 (6)
Sex: Female, Male (Count of Participants)
Female	2 40%	1 20%	1 20%	3 60%	1 20%	8 32%
Male	3 60%	4 80%	4 80%	2 40%	4 80%	17 68%
Region of Enrollment (participants) [Number]
United States	5 100%	5 100%	5 100%	5 100%	5 100%	25 100%

Outcome Measures

1. Primary Outcome

Title	Number Adverse Events (AEs)
Description	An AE is any untoward medical occurrence in a subject administered study drug and that does not necessarily have a causal relationship with the study drug. An AE could therefore be any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the study drug.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

The analysis population consisted of all subjects who received a dose of study drug.

Arm/Group Title	AB103 7.5 µg/kg	AB103 37.5 µg/kg	AB103 150 µg/kg	AB103 450 µg/kg	Placebo
Arm/Group Description	Each subject received a single IV infusion of AB103 7.5 µg/kg	Each subject received a single IV infusion of AB103 37.5 µg/kg	Each subject received a single IV infusion of 150 µg/kg	Each subject received a single IV infusion of 450 µg/kg	Each subject received a single IV infusion of normal saline (0.9% sodium chloride)
Measure Participants	5	5	5	5	5
Number [adverse events]	7	2	1	9	3

2. Primary Outcome

Title	Number of Serious Adverse Events (SAEs)
Description	A serious adverse event (SAE) is an AE occurring during any study phase and at any dose of the study drug (AB103 or placebo) that fulfills one or more of the following criteria: Results in death Is life-threatening (i.e., the subject was, in the opinion of the Investigator, at immediate risk of death from the event as it occurred) Requires or prolongs hospitalization Results in persistent or significant disability or incapacity (i.e., the event causes a substantial disruption of a person's ability to conduct normal life functions) Is a congenital anomaly or birth defect, or Is an important and significant medical event.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

The analysis population consisted of all subjects receiving a dose of study drug.

Arm/Group Title	AB103 7.5 µg/kg	AB103 37.5 µg/kg	AB103 150 µg/kg	AB103 450 µg/kg	Placebo
Arm/Group Description	AB103 single IV infusion of 7.5 µg/kg	AB103 single IV infusion of 37.5 µg/kg	AB103 single IV infusion of 150 µg/kg	AB103 single IV infusion of 450 µg/kg	Normal saline (0.9% sodium chloride) single IV infusion
Measure Participants	5	5	5	5	5
Number [serious adverse events]	0	0	0	0	0

3. Primary Outcome

Title	Number of Dose-limiting Toxicities (DLTs)
Description	DLTs were defined as the emergence of one or more selected AEs that reached a threshold that may justify stopping the trial.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AB103 7.5 µg/kg	AB103 37.5 µg/kg	AB103 150 µg/kg	AB103 450 µg/kg	Placebo
Arm/Group Description	AB103 single IV infusion of 7.5 µg/kg	AB103 single IV infusion of 37.5 µg/kg	AB103 single IV infusion of 150 µg/kg	AB103 single IV infusion of 450 µg/kg	Normal saline (0.9% sodium chloride) single IV infusion
Measure Participants	5	5	5	5	5
Number [DLTs]	0	0	0	0	0

4. Secondary Outcome

Title	Area Under the Plasma Concentration-time Curve (AUC)
Description	Area under the plasma concentration-time curve (AUC) from time zero to infinity following a single dose of study drug, obtained via noncompartmental methods. It is an integrated measure of study drug plasma exposure.
Time Frame	Whole blood was collected pre-dose; at the mid-point of the infusion; at 1, 2, 5, 10, 20, 30, and 60 minutes post-infusion; and at approximately 24 hours post-infusion for the measurement of AB103 plasma concentrations.

Outcome Measure Data

Analysis Population Description

AUC could not be determined in the AB103 7.5 µg/kg group and the placebo group because of the number of plasma concentration results that were undetectable.

Arm/Group Title	AB103 37.5 µg/kg	AB103 150 µg/kg	AB103 450 µg/kg
Arm/Group Description	Each subject received a single IV infusion of AB103 37.5 µg/kg	Each subject received a single IV infusion of AB103 150 µg/kg	Each subject received a single IV infusion of AB103 450 µg/kg
Measure Participants	5	5	5
Median (Full Range) [ng*min/mL]	527	2085	5831

5. Secondary Outcome

Title	Cmax
Description	Maximum plasma concentration
Time Frame	Whole blood was collected pre-dose; at the mid-point of the infusion; at 1, 2, 5, 10, 20, 30, and 60 minutes post-infusion; and at approximately 24 hours post-infusion for the measurement of AB103 plasma concentrations.

Outcome Measure Data

Analysis Population Description

Cmax is not available (applicable) to placebo patients (no detectable plasma concentrations).

Arm/Group Title	AB103 7.5 µg/kg	AB103 37.5 µg/kg	AB103 150 µg/kg	AB103 450 µg/kg
Arm/Group Description	Each subject received a single IV infusion of AB103 7.5 µg/kg	Each subject received a single IV infusion of AB103 37.5 µg/kg	Each subject received a single IV infusion of AB103 150 µg/kg	Each subject received a single IV infusion of AB103 450 µg/kg
Measure Participants	5	5	5	5
Median (Full Range) [ng/mL]	10.63	52.67	190.90	611.19

6. Secondary Outcome

Title	Apparent Terminal Plasma Half-life (T1/2)
Description	Apparent terminal plasma half-life (T1/2) is the amount of time for plasma concentrations to decline by 50%.
Time Frame	Whole blood was collected pre-dose; at the mid-point of the infusion; at 1, 2, 5, 10, 20, 30, and 60 minutes post-infusion; and at approximately 24 hours post-infusion for the measurement of AB103 plasma concentrations.

Outcome Measure Data

Analysis Population Description

This outcome measure could not be determined in the 7.5 µg/kg dose group because of the frequency of undetectable plasma concentrations. It was not determined for placebo subjects (undetectable plasma concentrations).

Arm/Group Title	AB103 37.5 µg/kg	AB103 150 µg/kg	AB103 450 µg/kg
Arm/Group Description	Each subject received a single IV infusion of AB103 37.5 µg/kg	Each subject received a single IV infusion of AB103 150 µg/kg	Each subject received a single IV infusion of AB103 450 µg/kg
Measure Participants	5	5	5
Median (Full Range) [hours (h)]	1.42	1.36	1.28

7. Secondary Outcome

Title	Clearance (CL)
Description	Clearance (CL) is the volume of plasma completely cleared of drug per unit of time.
Time Frame	Whole blood was collected pre-dose; at the mid-point of the infusion; at 1, 2, 5, 10, 20, 30, and 60 minutes post-infusion; and at approximately 24 hours post-infusion for the measurement of AB103 plasma concentrations.

Outcome Measure Data

Analysis Population Description

Clearance was not determined in the 7.5 µg/kg dose group because of the frequency of undetectable AB103 plasma concentrations. Clearance was not determined in the placebo group (undetectable plasma concentrations).

Arm/Group Title	AB103 37.5 µg/kg	AB103 150 µg/kg	AB103 450 µg/kg
Arm/Group Description	Each subject received a single IV infusion of AB103 37.5 µg/kg	Each subject received a single IV infusion of AB103 150 µg/kg	Each subject received a single IV infusion of AB103 450 µg/kg
Measure Participants	5	5	5
Median (Full Range) [mL/min/kg]	71	72	77

Adverse Events

Time Frame	2 weeks
Arm/Group Title	AB103 7.5 µg/kg		AB103 37.5 µg/kg		AB103 150 µg/kg		AB103 450 µg/kg		Placebo
Arm/Group Description	AB103 7.5 µg/kg administered as a single IV infusion		AB103 37.5 µg/kg administered as a single IV infusion		AB103 150 µg/kg administered as a single IV infusion		AB103 450 µg/kg administered as a single IV infusion		Normal saline (0.9% sodium chloride) administered as a single IV infusion
All Cause Mortality
	AB103 7.5 µg/kg		AB103 37.5 µg/kg		AB103 150 µg/kg		AB103 450 µg/kg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/5 (0%)		0/5 (0%)		0/5 (0%)		0/5 (0%)
Serious Adverse Events
	AB103 7.5 µg/kg		AB103 37.5 µg/kg		AB103 150 µg/kg		AB103 450 µg/kg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/5 (0%)		0/5 (0%)		0/5 (0%)		0/5 (0%)
Other (Not Including Serious) Adverse Events
	AB103 7.5 µg/kg		AB103 37.5 µg/kg		AB103 150 µg/kg		AB103 450 µg/kg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/5 (20%)		1/5 (20%)		1/5 (20%)		2/5 (40%)		2/5 (40%)
Eye disorders
Lacrimation increased	1/5 (20%)		0/5 (0%)		0/5 (0%)		0/5 (0%)		0/5 (0%)
Gastrointestinal disorders
Abdominal pain	1/5 (20%)		0/5 (0%)		0/5 (0%)		0/5 (0%)		0/5 (0%)
Flatulence	1/5 (20%)		0/5 (0%)		0/5 (0%)		0/5 (0%)		0/5 (0%)
General disorders
Fatigue	1/5 (20%)		0/5 (0%)		0/5 (0%)		1/5 (20%)		0/5 (0%)
Pyrexia	0/5 (0%)		0/5 (0%)		0/5 (0%)		1/5 (20%)		0/5 (0%)
Infections and infestations
Upper respiratory tract infection	0/5 (0%)		0/5 (0%)		0/5 (0%)		1/5 (20%)		0/5 (0%)
Musculoskeletal and connective tissue disorders
Myalgia	0/5 (0%)		0/5 (0%)		1/5 (20%)		1/5 (20%)		0/5 (0%)
Arthralgia	0/5 (0%)		0/5 (0%)		0/5 (0%)		0/5 (0%)		1/5 (20%)
Nervous system disorders
Headache	1/5 (20%)		0/5 (0%)		0/5 (0%)		0/5 (0%)		0/5 (0%)
Renal and urinary disorders
Pyuria	0/5 (0%)		0/5 (0%)		0/5 (0%)		1/5 (20%)		0/5 (0%)
Reproductive system and breast disorders
Pruritis genital	0/5 (0%)		0/5 (0%)		0/5 (0%)		1/5 (20%)		0/5 (0%)
Respiratory, thoracic and mediastinal disorders
Nasal congestion	1/5 (20%)		0/5 (0%)		0/5 (0%)		0/5 (0%)		1/5 (20%)
Sneezing	1/5 (20%)		0/5 (0%)		0/5 (0%)		0/5 (0%)		0/5 (0%)
Skin and subcutaneous tissue disorders
Rash papular	0/5 (0%)		1/5 (20%)		0/5 (0%)		0/5 (0%)		0/5 (0%)
Pruritis	0/5 (0%)		1/5 (20%)		0/5 (0%)		0/5 (0%)		0/5 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.