Trial Outcomes & Findings for TMB-365 and TMB-380 in Suppressed HIV-1 Infected Individuals (NCT NCT05275998)
NCT ID: NCT05275998
Last Updated: 2025-10-22
Results Overview
Grade 3, Grade 4, Serious Adverse reactions related to TMB-365 and TMB-380 infusions
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
51 participants
Primary outcome timeframe
12 weeks (Sentinel Group 1), 16 weeks (Sentinel Group 2, 3), 28 weeks (Core Group)
Results posted on
2025-10-22
Participant Flow
Participant milestones
| Measure |
Sentinel Group 1
10 HIV-1 infected subjects will receive one infusion of 2400 mg of each antibody, TMB-365 and TMB-380 and be followed for safety and pharmacokinetics. Oral suppressive cART will be continued throughout the course of the study participation.
TMB-365/TMB-380: Monoclonal antibodies to be given intravenously
|
Sentinel Group 2
10 HIV-1 infected subjects will receive one infusion of 3200 mg of each antibody, TMB-365 and TMB-380 and be followed for safety and pharmacokinetics. Oral suppressive cART will be continued throughout the course of the study participation.
TMB-365/TMB-380: Monoclonal antibodies to be given intravenously
|
Sentinel Group 3
10 HIV-1 infected subjects will receive one infusion of 4800 mg of each antibody, TMB-365 and TMB-380 and be followed for safety and pharmacokinetics. Oral suppressive cART will be continued throughout the course of the study participation.
TMB-365/TMB-380: Monoclonal antibodies to be given intravenously
|
Core Group 1
21 HIV-1 infected subjects will receive 4800 mg infusions of each antibody, TMB-365 and TMB-380 every 8 weeks and be followed for safety, pharmacokinetics, and ability to maintain antiviral activity. Oral suppressive cART will be discontinued for 24 weeks then resumed at week 24 with follow-up at week 28.
TMB-365/TMB-380: Monoclonal antibodies to be given intravenously
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
21
|
|
Overall Study
COMPLETED
|
10
|
10
|
9
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
3
|
Reasons for withdrawal
| Measure |
Sentinel Group 1
10 HIV-1 infected subjects will receive one infusion of 2400 mg of each antibody, TMB-365 and TMB-380 and be followed for safety and pharmacokinetics. Oral suppressive cART will be continued throughout the course of the study participation.
TMB-365/TMB-380: Monoclonal antibodies to be given intravenously
|
Sentinel Group 2
10 HIV-1 infected subjects will receive one infusion of 3200 mg of each antibody, TMB-365 and TMB-380 and be followed for safety and pharmacokinetics. Oral suppressive cART will be continued throughout the course of the study participation.
TMB-365/TMB-380: Monoclonal antibodies to be given intravenously
|
Sentinel Group 3
10 HIV-1 infected subjects will receive one infusion of 4800 mg of each antibody, TMB-365 and TMB-380 and be followed for safety and pharmacokinetics. Oral suppressive cART will be continued throughout the course of the study participation.
TMB-365/TMB-380: Monoclonal antibodies to be given intravenously
|
Core Group 1
21 HIV-1 infected subjects will receive 4800 mg infusions of each antibody, TMB-365 and TMB-380 every 8 weeks and be followed for safety, pharmacokinetics, and ability to maintain antiviral activity. Oral suppressive cART will be discontinued for 24 weeks then resumed at week 24 with follow-up at week 28.
TMB-365/TMB-380: Monoclonal antibodies to be given intravenously
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
0
|
Baseline Characteristics
TMB-365 and TMB-380 in Suppressed HIV-1 Infected Individuals
Baseline characteristics by cohort
| Measure |
Sentinel Group 1
n=10 Participants
10 HIV-1 infected subjects will receive one infusion of 2400 mg of each antibody, TMB-365 and TMB-380 and be followed for safety and pharmacokinetics. Oral suppressive cART will be continued throughout the course of the study participation.
TMB-365/TMB-380: Monoclonal antibodies to be given intravenously
|
Sentinel Group 2
n=10 Participants
10 HIV-1 infected subjects will receive one infusion of 3200 mg of each antibody, TMB-365 and TMB-380 and be followed for safety and pharmacokinetics. Oral suppressive cART will be continued throughout the course of the study participation.
TMB-365/TMB-380: Monoclonal antibodies to be given intravenously
|
Sentinel Group 3
n=10 Participants
10 HIV-1 infected subjects will receive one infusion of 4800 mg of each antibody, TMB-365 and TMB-380 and be followed for safety and pharmacokinetics. Oral suppressive cART will be continued throughout the course of the study participation.
TMB-365/TMB-380: Monoclonal antibodies to be given intravenously
|
Core Group 1
n=21 Participants
20 HIV-1 infected subjects will receive 4800 mg infusions of each antibody, TMB-365 and TMB-380 every 8 weeks and be followed for safety, pharmacokinetics, and ability to maintain antiviral activity. Oral suppressive cART will be discontinued for 24 weeks then resumed at week 24 with follow-up at week 28.
TMB-365/TMB-380: Monoclonal antibodies to be given intravenously
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
44.5 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
43.1 years
STANDARD_DEVIATION 12.1 • n=7 Participants
|
44 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
49.3 years
STANDARD_DEVIATION 12.4 • n=4 Participants
|
46.1 years
STANDARD_DEVIATION 10.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12 weeks (Sentinel Group 1), 16 weeks (Sentinel Group 2, 3), 28 weeks (Core Group)Population: Target enrollment in Core Group 1 is 20 participants. 21 were enrolled as one subject developed a serious medical condition between screen and baseline and was replaced. Therefore Core Group 1 consists of 20 evaluable participants.
Grade 3, Grade 4, Serious Adverse reactions related to TMB-365 and TMB-380 infusions
Outcome measures
| Measure |
Sentinel Group 1
n=10 Participants
10 HIV-1 infected subjects will receive one infusion of 2400 mg of each antibody, TMB-365 and TMB-380 and be followed for safety and pharmacokinetics. Oral suppressive cART will be continued throughout the course of the study participation.
TMB-365/TMB-380: Monoclonal antibodies to be given intravenously
|
Sentinel Group 2
n=10 Participants
10 HIV-1 infected subjects will receive one infusion of 3200 mg of each antibody, TMB-365 and TMB-380 and be followed for safety and pharmacokinetics. Oral suppressive cART will be continued throughout the course of the study participation.
TMB-365/TMB-380: Monoclonal antibodies to be given intravenously
|
Sentinel Group 3
n=10 Participants
10 HIV-1 infected subjects will receive one infusion of 4800 mg of each antibody, TMB-365 and TMB-380 and be followed for safety and pharmacokinetics. Oral suppressive cART will be continued throughout the course of the study participation.
TMB-365/TMB-380: Monoclonal antibodies to be given intravenously
|
Core Group 1
n=20 Participants
20 HIV-1 infected subjects will receive 4800 mg infusions of each antibody, TMB-365 and TMB-380 every 8 weeks and be followed for safety, pharmacokinetics, and ability to maintain antiviral activity. Oral suppressive cART will be discontinued for 24 weeks then resumed at week 24 with follow-up at week 52.
TMB-365/TMB-380: Monoclonal antibodies to be given intravenously
|
|---|---|---|---|---|
|
Safety of TMB-365 and TMB-380 Given Intravenously (Sentinel and Core)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: One participant enrolled in Sentinel Group 3 was erroneously dosed with 1600 mg and was excluded from the analysis.
In the Sentinel Group, participants received a single dose of TMB-365 and TMB-380 at 2400 mg, 3200 mg, or 4800 mg each. TMB-365 concentrations were measured using a validated ELISA, and the Week 8 concentration was used to guide dose selection for the Core Group.
Outcome measures
| Measure |
Sentinel Group 1
n=10 Participants
10 HIV-1 infected subjects will receive one infusion of 2400 mg of each antibody, TMB-365 and TMB-380 and be followed for safety and pharmacokinetics. Oral suppressive cART will be continued throughout the course of the study participation.
TMB-365/TMB-380: Monoclonal antibodies to be given intravenously
|
Sentinel Group 2
n=10 Participants
10 HIV-1 infected subjects will receive one infusion of 3200 mg of each antibody, TMB-365 and TMB-380 and be followed for safety and pharmacokinetics. Oral suppressive cART will be continued throughout the course of the study participation.
TMB-365/TMB-380: Monoclonal antibodies to be given intravenously
|
Sentinel Group 3
n=9 Participants
10 HIV-1 infected subjects will receive one infusion of 4800 mg of each antibody, TMB-365 and TMB-380 and be followed for safety and pharmacokinetics. Oral suppressive cART will be continued throughout the course of the study participation.
TMB-365/TMB-380: Monoclonal antibodies to be given intravenously
|
Core Group 1
20 HIV-1 infected subjects will receive 4800 mg infusions of each antibody, TMB-365 and TMB-380 every 8 weeks and be followed for safety, pharmacokinetics, and ability to maintain antiviral activity. Oral suppressive cART will be discontinued for 24 weeks then resumed at week 24 with follow-up at week 52.
TMB-365/TMB-380: Monoclonal antibodies to be given intravenously
|
|---|---|---|---|---|
|
Pharmacokinetics of a Single Dose TMB-365 Given Intravenously (Sentinel)
|
0.50 mcg/mL
Standard Deviation 1.23
|
1.91 mcg/mL
Standard Deviation 3.19
|
15.13 mcg/mL
Standard Deviation 13.45
|
—
|
PRIMARY outcome
Timeframe: Week 8, 16, and 24Population: The Core Group enrolled 21 participants (one discontinued and was replaced), and 20 were considered evaluable. Two discontinued immediately after the Week 8 infusion, and one had no Week 24 data.
Core Group participants received 4800 mg every 8 weeks.TMB-365 concentrations were measured using a validated ELISA. Trough concentrations are reported.
Outcome measures
| Measure |
Sentinel Group 1
n=20 Participants
10 HIV-1 infected subjects will receive one infusion of 2400 mg of each antibody, TMB-365 and TMB-380 and be followed for safety and pharmacokinetics. Oral suppressive cART will be continued throughout the course of the study participation.
TMB-365/TMB-380: Monoclonal antibodies to be given intravenously
|
Sentinel Group 2
10 HIV-1 infected subjects will receive one infusion of 3200 mg of each antibody, TMB-365 and TMB-380 and be followed for safety and pharmacokinetics. Oral suppressive cART will be continued throughout the course of the study participation.
TMB-365/TMB-380: Monoclonal antibodies to be given intravenously
|
Sentinel Group 3
10 HIV-1 infected subjects will receive one infusion of 4800 mg of each antibody, TMB-365 and TMB-380 and be followed for safety and pharmacokinetics. Oral suppressive cART will be continued throughout the course of the study participation.
TMB-365/TMB-380: Monoclonal antibodies to be given intravenously
|
Core Group 1
20 HIV-1 infected subjects will receive 4800 mg infusions of each antibody, TMB-365 and TMB-380 every 8 weeks and be followed for safety, pharmacokinetics, and ability to maintain antiviral activity. Oral suppressive cART will be discontinued for 24 weeks then resumed at week 24 with follow-up at week 52.
TMB-365/TMB-380: Monoclonal antibodies to be given intravenously
|
|---|---|---|---|---|
|
Pharmacokinetics of TMB-365 Given Intravenously Every 8 Weeks (Core)
Week 8 pre-dose concentration
|
29.54 mcg/mL
Standard Deviation 30.18
|
—
|
—
|
—
|
|
Pharmacokinetics of TMB-365 Given Intravenously Every 8 Weeks (Core)
Week 16 pre-dose concentration
|
29.12 mcg/mL
Standard Deviation 31.25
|
—
|
—
|
—
|
|
Pharmacokinetics of TMB-365 Given Intravenously Every 8 Weeks (Core)
Week 24 trough concentration
|
29.11 mcg/mL
Standard Deviation 35.94
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 8Population: One participant enrolled in Sentinel Group 3 was erroneously dosed with 1600 mg and was excluded from the analysis.
In the Sentinel Group, participants received a single dose of TMB-365 and TMB-380 at 2400 mg, 3200 mg, or 4800 mg each. TMB-380 concentrations were measured using a validated ELISA, and the Week 8 concentration was used to guide dose selection for the Core Group.
Outcome measures
| Measure |
Sentinel Group 1
n=10 Participants
10 HIV-1 infected subjects will receive one infusion of 2400 mg of each antibody, TMB-365 and TMB-380 and be followed for safety and pharmacokinetics. Oral suppressive cART will be continued throughout the course of the study participation.
TMB-365/TMB-380: Monoclonal antibodies to be given intravenously
|
Sentinel Group 2
n=10 Participants
10 HIV-1 infected subjects will receive one infusion of 3200 mg of each antibody, TMB-365 and TMB-380 and be followed for safety and pharmacokinetics. Oral suppressive cART will be continued throughout the course of the study participation.
TMB-365/TMB-380: Monoclonal antibodies to be given intravenously
|
Sentinel Group 3
n=9 Participants
10 HIV-1 infected subjects will receive one infusion of 4800 mg of each antibody, TMB-365 and TMB-380 and be followed for safety and pharmacokinetics. Oral suppressive cART will be continued throughout the course of the study participation.
TMB-365/TMB-380: Monoclonal antibodies to be given intravenously
|
Core Group 1
20 HIV-1 infected subjects will receive 4800 mg infusions of each antibody, TMB-365 and TMB-380 every 8 weeks and be followed for safety, pharmacokinetics, and ability to maintain antiviral activity. Oral suppressive cART will be discontinued for 24 weeks then resumed at week 24 with follow-up at week 52.
TMB-365/TMB-380: Monoclonal antibodies to be given intravenously
|
|---|---|---|---|---|
|
Pharmacokinetics of a Single Dose TMB-380 Given Intravenously (Sentinel)
|
59.59 mcg/mL
Standard Deviation 14.59
|
63.05 mcg/mL
Standard Deviation 16.47
|
86.43 mcg/mL
Standard Deviation 24.09
|
—
|
PRIMARY outcome
Timeframe: Weeks 8, 16, and 24Population: The Core Group enrolled 21 participants (one discontinued and was replaced), and 20 were considered evaluable. Two discontinued immediately after the Week 8 infusion, and one had no Week 24 data.
Core Group participants received 4800 mg every 8 weeks.TMB-380 concentrations were measured using a validated ELISA. Trough concentrations are reported.
Outcome measures
| Measure |
Sentinel Group 1
n=20 Participants
10 HIV-1 infected subjects will receive one infusion of 2400 mg of each antibody, TMB-365 and TMB-380 and be followed for safety and pharmacokinetics. Oral suppressive cART will be continued throughout the course of the study participation.
TMB-365/TMB-380: Monoclonal antibodies to be given intravenously
|
Sentinel Group 2
10 HIV-1 infected subjects will receive one infusion of 3200 mg of each antibody, TMB-365 and TMB-380 and be followed for safety and pharmacokinetics. Oral suppressive cART will be continued throughout the course of the study participation.
TMB-365/TMB-380: Monoclonal antibodies to be given intravenously
|
Sentinel Group 3
10 HIV-1 infected subjects will receive one infusion of 4800 mg of each antibody, TMB-365 and TMB-380 and be followed for safety and pharmacokinetics. Oral suppressive cART will be continued throughout the course of the study participation.
TMB-365/TMB-380: Monoclonal antibodies to be given intravenously
|
Core Group 1
20 HIV-1 infected subjects will receive 4800 mg infusions of each antibody, TMB-365 and TMB-380 every 8 weeks and be followed for safety, pharmacokinetics, and ability to maintain antiviral activity. Oral suppressive cART will be discontinued for 24 weeks then resumed at week 24 with follow-up at week 52.
TMB-365/TMB-380: Monoclonal antibodies to be given intravenously
|
|---|---|---|---|---|
|
Pharmacokinetics of TMB-380 Given Intravenously Every 8 Weeks (Core)
Week 8 pre-dose concentration
|
83.72 mcg/mL
Standard Deviation 25.13
|
—
|
—
|
—
|
|
Pharmacokinetics of TMB-380 Given Intravenously Every 8 Weeks (Core)
Week 16 pre-dose concentration
|
91.48 mcg/mL
Standard Deviation 21.93
|
—
|
—
|
—
|
|
Pharmacokinetics of TMB-380 Given Intravenously Every 8 Weeks (Core)
Week 24 trough concentration
|
107.12 mcg/mL
Standard Deviation 28.44
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 24Population: The Core Group enrolled 21 participants (one discontinued and was replaced), and 20 were considered evaluable. Two discontinued prematurely and one had no Week 24 data. The Sentinel Group participants received TMB-365 and TMB-380 while continuing cART, so antiviral activity was not assessed.
Plasma HIV-1 level below 50 copies/mL in study subjects at week 24 during maintenance therapy with TMB-365/TMB-380 infusions in Core Subjects only.
Outcome measures
| Measure |
Sentinel Group 1
n=17 Participants
10 HIV-1 infected subjects will receive one infusion of 2400 mg of each antibody, TMB-365 and TMB-380 and be followed for safety and pharmacokinetics. Oral suppressive cART will be continued throughout the course of the study participation.
TMB-365/TMB-380: Monoclonal antibodies to be given intravenously
|
Sentinel Group 2
10 HIV-1 infected subjects will receive one infusion of 3200 mg of each antibody, TMB-365 and TMB-380 and be followed for safety and pharmacokinetics. Oral suppressive cART will be continued throughout the course of the study participation.
TMB-365/TMB-380: Monoclonal antibodies to be given intravenously
|
Sentinel Group 3
10 HIV-1 infected subjects will receive one infusion of 4800 mg of each antibody, TMB-365 and TMB-380 and be followed for safety and pharmacokinetics. Oral suppressive cART will be continued throughout the course of the study participation.
TMB-365/TMB-380: Monoclonal antibodies to be given intravenously
|
Core Group 1
20 HIV-1 infected subjects will receive 4800 mg infusions of each antibody, TMB-365 and TMB-380 every 8 weeks and be followed for safety, pharmacokinetics, and ability to maintain antiviral activity. Oral suppressive cART will be discontinued for 24 weeks then resumed at week 24 with follow-up at week 52.
TMB-365/TMB-380: Monoclonal antibodies to be given intravenously
|
|---|---|---|---|---|
|
Antiviral Activity of the Combination of TMB-365 in Combination With TMB-380 as Maintenance Therapy (Core)
|
16 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Resistance testing was conducted only in Core participants with virologic failure. As no virologic failures were observed, no resistance analyses were performed. Sentinel Group participants received TMB-365 or TMB-380 while continuing cART; therefore, resistance was not assessed.
Phenotype and genotype of HIV-1 variants in study subjects who fail to maintain antiviral response on infusions of TMB-365 and TMB-380
Outcome measures
| Measure |
Sentinel Group 1
10 HIV-1 infected subjects will receive one infusion of 2400 mg of each antibody, TMB-365 and TMB-380 and be followed for safety and pharmacokinetics. Oral suppressive cART will be continued throughout the course of the study participation.
TMB-365/TMB-380: Monoclonal antibodies to be given intravenously
|
Sentinel Group 2
10 HIV-1 infected subjects will receive one infusion of 3200 mg of each antibody, TMB-365 and TMB-380 and be followed for safety and pharmacokinetics. Oral suppressive cART will be continued throughout the course of the study participation.
TMB-365/TMB-380: Monoclonal antibodies to be given intravenously
|
Sentinel Group 3
10 HIV-1 infected subjects will receive one infusion of 4800 mg of each antibody, TMB-365 and TMB-380 and be followed for safety and pharmacokinetics. Oral suppressive cART will be continued throughout the course of the study participation.
TMB-365/TMB-380: Monoclonal antibodies to be given intravenously
|
Core Group 1
20 HIV-1 infected subjects will receive 4800 mg infusions of each antibody, TMB-365 and TMB-380 every 8 weeks and be followed for safety, pharmacokinetics, and ability to maintain antiviral activity. Oral suppressive cART will be discontinued for 24 weeks then resumed at week 24 with follow-up at week 52.
TMB-365/TMB-380: Monoclonal antibodies to be given intravenously
|
|---|---|---|---|---|
|
Resistance to TMB-365 and TMB-380 (Core)
|
0 Participants
|
—
|
—
|
—
|
Adverse Events
Sentinel Group 1
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Sentinel Group 2
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Sentinel Group 3
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Core Group 1
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sentinel Group 1
n=10 participants at risk
10 HIV-1 infected subjects will receive one infusion of 2400 mg of each antibody, TMB-365 and TMB-380 and be followed for safety and pharmacokinetics. Oral suppressive cART will be continued throughout the course of the study participation.
TMB-365/TMB-380: Monoclonal antibodies to be given intravenously
|
Sentinel Group 2
n=10 participants at risk
10 HIV-1 infected subjects will receive one infusion of 3200 mg of each antibody, TMB-365 and TMB-380 and be followed for safety and pharmacokinetics. Oral suppressive cART will be continued throughout the course of the study participation.
TMB-365/TMB-380: Monoclonal antibodies to be given intravenously
|
Sentinel Group 3
n=10 participants at risk
10 HIV-1 infected subjects will receive one infusion of 4800 mg of each antibody, TMB-365 and TMB-380 and be followed for safety and pharmacokinetics. Oral suppressive cART will be continued throughout the course of the study participation.
TMB-365/TMB-380: Monoclonal antibodies to be given intravenously
|
Core Group 1
n=21 participants at risk
21 HIV-1 infected subjects will receive 4800 mg infusions of each antibody, TMB-365 and TMB-380 every 8 weeks and be followed for safety, pharmacokinetics, and ability to maintain antiviral activity. Oral suppressive cART will be discontinued for 24 weeks then resumed at week 24 with follow-up at week 28.
TMB-365/TMB-380: Monoclonal antibodies to be given intravenously
|
|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
30.0%
3/10 • Number of events 3 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
0.00%
0/10 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
4.8%
1/21 • Number of events 1 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
|
Skin and subcutaneous tissue disorders
rash
|
0.00%
0/10 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
14.3%
3/21 • Number of events 3 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
|
General disorders
fatigue
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
20.0%
2/10 • Number of events 2 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
0.00%
0/10 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
19.0%
4/21 • Number of events 4 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
|
Skin and subcutaneous tissue disorders
papules
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
0.00%
0/10 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
0.00%
0/21 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
|
Nervous system disorders
headache
|
0.00%
0/10 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
0.00%
0/10 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
14.3%
3/21 • Number of events 3 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
|
Psychiatric disorders
attention deficit disorder
|
0.00%
0/10 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
0.00%
0/10 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
0.00%
0/10 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
9.5%
2/21 • Number of events 2 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
|
Psychiatric disorders
depression
|
0.00%
0/10 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
0.00%
0/10 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
0.00%
0/10 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
4.8%
1/21 • Number of events 1 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
|
Immune system disorders
hypersensitivity
|
0.00%
0/10 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
20.0%
2/10 • Number of events 2 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
0.00%
0/10 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
0.00%
0/21 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
|
Infections and infestations
upper respiratory infection
|
0.00%
0/10 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
20.0%
2/10 • Number of events 2 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
9.5%
2/21 • Number of events 2 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
|
Infections and infestations
syphilis
|
0.00%
0/10 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
0.00%
0/10 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
0.00%
0/21 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
|
Infections and infestations
streptococcal pharyngitis
|
0.00%
0/10 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
0.00%
0/10 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
0.00%
0/21 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
|
Skin and subcutaneous tissue disorders
eczema
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
0.00%
0/10 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
0.00%
0/10 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
0.00%
0/21 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
oral pain
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
0.00%
0/10 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
0.00%
0/21 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
|
Vascular disorders
flushing
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
0.00%
0/10 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
0.00%
0/10 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
9.5%
2/21 • Number of events 2 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
|
Vascular disorders
coldness
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
0.00%
0/10 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
0.00%
0/10 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
0.00%
0/21 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
basal cell carcinoma
|
0.00%
0/10 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
0.00%
0/10 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
0.00%
0/21 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/10 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
0.00%
0/10 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
0.00%
0/10 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
4.8%
1/21 • Number of events 1 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
|
Gastrointestinal disorders
esophageal stenosis
|
0.00%
0/10 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
0.00%
0/10 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
0.00%
0/10 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
4.8%
1/21 • Number of events 1 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
|
Infections and infestations
fungal infection
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
0.00%
0/10 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
0.00%
0/10 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
9.5%
2/21 • Number of events 2 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
|
Infections and infestations
conjunctivitis
|
0.00%
0/10 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
0.00%
0/10 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
0.00%
0/21 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
0.00%
0/10 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
0.00%
0/10 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
0.00%
0/10 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
9.5%
2/21 • Number of events 2 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
|
Blood and lymphatic system disorders
anemia
|
0.00%
0/10 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
0.00%
0/10 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
0.00%
0/10 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
4.8%
1/21 • Number of events 1 • Adverse events were collected for the duration of the study which included a screening period of 6 weeks, 12 weeks for the 2400 mg and 3200 mg single dose group, 16 weeks for the 4800 mg single dose group, and 28 weeks for the 4800 mg multiple dose group (infusions for 24 weeks and 4 weeks of follow up)
Adverse event reporting definitions do not differ from that described by clinicaltrials.gov
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Multi-Center Study Data are sponsor's property and sponsor must authorize publication. Sponsor and PIs together determine how a manuscript is written, edited and the publication to which it is submitted. Sponsor has final determination in these matters. PIs may publish or discuss their own study data with sponsor review at least 30 days in advance. Sponsor may require deletion of sponsor's confidential information and correction of inaccuracies, and request an embargo up to 60 additional days.
- Publication restrictions are in place
Restriction type: OTHER