Trial Outcomes & Findings for Safety and Tolerability of PRO 140 in HIV Uninfected Male Volunteers (NCT NCT00110591)

NCT ID: NCT00110591

Last Updated: 2023-03-14

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 20 participants
• Primary outcome timeframe: 60 days
• Results posted on: 2023-03-14

Participant Flow

Participant milestones

Measure	Placebo Intravenous placebo for PRO 140 PRO 140: Monoclonal antibody to CCR5	PRO 140 Dose 1 0.1 mg/kg PRO 140 by intravenous infusion PRO 140: Monoclonal antibody to CCR5	PRO 140 Dose 2 0.5 mg/kg PRO 140 by intravenous infusion PRO 140: Monoclonal antibody to CCR5	PRO 140 Dose 3 2.0 mg/kg PRO 140 by intravenous infusion PRO 140: Monoclonal antibody to CCR5	PRO 140 Dose 4 5.0 mg/kg PRO 140 by intravenous infusion PRO 140: Monoclonal antibody to CCR5
Overall Study STARTED	4	4	4	4	4
Overall Study COMPLETED	4	4	4	4	4
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Tolerability of PRO 140 in HIV Uninfected Male Volunteers

Baseline characteristics by cohort

Measure	Placebo n=4 Participants Intravenous placebo for PRO 140 PRO 140: Monoclonal antibody to CCR5	PRO 140 Dose 1 n=4 Participants 0.1 mg/kg PRO 140 by intravenous infusion PRO 140: Monoclonal antibody to CCR5	PRO 140 Dose 2 n=4 Participants 0.5 mg/kg PRO 140 by intravenous infusion PRO 140: Monoclonal antibody to CCR5	PRO 140 Dose 3 n=4 Participants 2.0 mg/kg PRO 140 by intravenous infusion PRO 140: Monoclonal antibody to CCR5	PRO 140 Dose 4 n=4 Participants 5.0 mg/kg PRO 140 by intravenous infusion PRO 140: Monoclonal antibody to CCR5	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants	20 Participants n=10 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Age, Continuous	26 years STANDARD_DEVIATION 7 • n=5 Participants	34 years STANDARD_DEVIATION 13 • n=7 Participants	30 years STANDARD_DEVIATION 12 • n=5 Participants	22 years STANDARD_DEVIATION 2 • n=4 Participants	21 years STANDARD_DEVIATION 2 • n=21 Participants	27 years STANDARD_DEVIATION 9 • n=10 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants	20 Participants n=10 Participants
Region of Enrollment United States	4 participants n=5 Participants	4 participants n=7 Participants	4 participants n=5 Participants	4 participants n=4 Participants	4 participants n=21 Participants	20 participants n=10 Participants

PRIMARY outcome

Timeframe: 60 days

Outcome measures

Measure	Placebo n=4 Participants Intravenous placebo for PRO 140 PRO 140: Monoclonal antibody to CCR5	PRO 140 Dose 1 n=4 Participants 0.1 mg/kg PRO 140 by intravenous infusion PRO 140: Monoclonal antibody to CCR5	PRO 140 Dose 2 n=4 Participants 0.5 mg/kg PRO 140 by intravenous infusion PRO 140: Monoclonal antibody to CCR5	PRO 140 Dose 3 n=4 Participants 2.0 mg/kg PRO 140 by intravenous infusion PRO 140: Monoclonal antibody to CCR5	PRO 140 Dose 4 n=4 Participants 5.0 mg/kg PRO 140 by intravenous infusion PRO 140: Monoclonal antibody to CCR5
Safety and Tolerability of PRO 140	4 number of subjects reporting AEs	4 number of subjects reporting AEs	0 number of subjects reporting AEs	4 number of subjects reporting AEs	3 number of subjects reporting AEs

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

PRO 140 Dose 1

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

PRO 140 Dose 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PRO 140 Dose 3

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

PRO 140 Dose 4

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=4 participants at risk Intravenous placebo for PRO 140 PRO 140: Monoclonal antibody to CCR5	PRO 140 Dose 1 n=4 participants at risk 0.1 mg/kg PRO 140 by intravenous infusion PRO 140: Monoclonal antibody to CCR5	PRO 140 Dose 2 n=4 participants at risk 0.5 mg/kg PRO 140 by intravenous infusion PRO 140: Monoclonal antibody to CCR5	PRO 140 Dose 3 n=4 participants at risk 2.0 mg/kg PRO 140 by intravenous infusion PRO 140: Monoclonal antibody to CCR5	PRO 140 Dose 4 n=4 participants at risk 5.0 mg/kg PRO 140 by intravenous infusion PRO 140: Monoclonal antibody to CCR5
Cardiac disorders Myocardial infarction	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	25.0% 1/4 • Number of events 1 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.

Other adverse events

Measure	Placebo n=4 participants at risk Intravenous placebo for PRO 140 PRO 140: Monoclonal antibody to CCR5	PRO 140 Dose 1 n=4 participants at risk 0.1 mg/kg PRO 140 by intravenous infusion PRO 140: Monoclonal antibody to CCR5	PRO 140 Dose 2 n=4 participants at risk 0.5 mg/kg PRO 140 by intravenous infusion PRO 140: Monoclonal antibody to CCR5	PRO 140 Dose 3 n=4 participants at risk 2.0 mg/kg PRO 140 by intravenous infusion PRO 140: Monoclonal antibody to CCR5	PRO 140 Dose 4 n=4 participants at risk 5.0 mg/kg PRO 140 by intravenous infusion PRO 140: Monoclonal antibody to CCR5
Cardiac disorders Fatal Myocardial infarction	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	25.0% 1/4 • Number of events 1 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.
Investigations high creatine phosphokinase level	50.0% 2/4 • Number of events 4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	50.0% 2/4 • Number of events 3 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	25.0% 1/4 • Number of events 1 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.
Gastrointestinal disorders Loose stools	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	25.0% 1/4 • Number of events 3 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.
Gastrointestinal disorders Nausea	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	25.0% 1/4 • Number of events 1 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.
Injury, poisoning and procedural complications Joint sprain	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	25.0% 1/4 • Number of events 2 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.
Investigations Alanine aminotransferase increased	25.0% 1/4 • Number of events 1 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.
Investigations Aspartate aminotransferase increased	50.0% 2/4 • Number of events 4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.
Investigations Blood alkaline phosphatase increased	25.0% 1/4 • Number of events 1 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.
Investigations Electrocardiogram T wave inversion	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	25.0% 1/4 • Number of events 1 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.
Investigations Gamma-glutamyltransferase increased	25.0% 1/4 • Number of events 3 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.
Investigations White blood cell count decreased	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	25.0% 1/4 • Number of events 1 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.
Musculoskeletal and connective tissue disorders Back Pain	25.0% 1/4 • Number of events 2 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	25.0% 1/4 • Number of events 1 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.
Musculoskeletal and connective tissue disorders Muscle rigidity	25.0% 1/4 • Number of events 1 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.
Musculoskeletal and connective tissue disorders Myalgia	25.0% 1/4 • Number of events 1 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.
Nervous system disorders Dizziness	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	25.0% 1/4 • Number of events 1 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.
Nervous system disorders Headache	25.0% 1/4 • Number of events 1 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	25.0% 1/4 • Number of events 1 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	50.0% 2/4 • Number of events 6 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	25.0% 1/4 • Number of events 1 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.
Nervous system disorders Paraesthesia	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	25.0% 1/4 • Number of events 1 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	25.0% 1/4 • Number of events 1 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	25.0% 1/4 • Number of events 1 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.
Respiratory, thoracic and mediastinal disorders Dry Throat	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	25.0% 1/4 • Number of events 1 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.
Respiratory, thoracic and mediastinal disorders Epistaxis	25.0% 1/4 • Number of events 7 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	25.0% 1/4 • Number of events 1 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	75.0% 3/4 • Number of events 3 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	25.0% 1/4 • Number of events 1 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	25.0% 1/4 • Number of events 1 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	25.0% 1/4 • Number of events 1 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	25.0% 1/4 • Number of events 1 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.	0.00% 0/4 • Adverse event data was collected over an 18-month period. Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.

Additional Information

Joe Meidling

CytoDyn, Inc.

Phone: 360-980-8524

Email: jmeidling@cytodyn.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER