Trial Outcomes & Findings for MGD014 in HIV-Infected Individuals on Suppressive Antiretroviral Therapy (NCT NCT03570918)
NCT ID: NCT03570918
Last Updated: 2022-09-02
Results Overview
Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of study drug administration through the End of Study visit.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
21 participants
Primary outcome timeframe
up to 77 days
Results posted on
2022-09-02
Participant Flow
Three participants who were treated in Period 1 (single dose) in the 10, 100, or 300 mcg/kg dose cohorts were also treated in Period 2 (multiple dose) in the 300 mcg/kg dose cohort.
Participant milestones
| Measure |
MGD014 0.1 Micrograms/Kilogram (mcg/kg)
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 0.3 mcg/kg
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 1.0 mcg/kg
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 3.0 mcg/kg
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 10.0 mcg/kg
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 30.0 mcg/kg
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 100.0 mcg/kg
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 300.0 mcg/kg
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 300 mcg/kg Multiple Doses
3 infusions given every 2 weeks over 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
1
|
1
|
4
|
3
|
3
|
3
|
3
|
3
|
0
|
|
Period 1
COMPLETED
|
1
|
1
|
4
|
3
|
3
|
3
|
3
|
3
|
0
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
|
Period 2
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The 3 participants treated with multiple doses of MGD014 were also treated with single doses of MGD014 at 10, 100 and 300 mg, respectively
Baseline characteristics by cohort
| Measure |
MGD014 0.1 mcg/kg
n=1 Participants
Single infusion of MGD014
|
MGD014 0.3 mcg/kg
n=1 Participants
Single infusion of MGD014
|
MGD014 1.0 mcg/kg
n=4 Participants
Single infusion of MGD014
|
MGD014 3.0 mcg/kg
n=3 Participants
Single infusion of MGD014
|
MGD014 10.0 mcg/kg
n=3 Participants
Single infusion of MGD014
|
MGD014 30 mcg/kg
n=3 Participants
Single infusion of MGD014
|
MGD014 100 mcg/kg
n=3 Participants
Single infusion of MGD014
|
MGD014 300 mcg/kg
n=3 Participants
Single infusion of MGD014
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
Period 1: Single Dose
|
40.0 years
STANDARD_DEVIATION NA • n=5 Participants • The 3 participants treated with multiple doses of MGD014 were also treated with single doses of MGD014 at 10, 100 and 300 mg, respectively
|
53.0 years
STANDARD_DEVIATION NA • n=7 Participants • The 3 participants treated with multiple doses of MGD014 were also treated with single doses of MGD014 at 10, 100 and 300 mg, respectively
|
49.8 years
STANDARD_DEVIATION 9.18 • n=5 Participants • The 3 participants treated with multiple doses of MGD014 were also treated with single doses of MGD014 at 10, 100 and 300 mg, respectively
|
37.9 years
STANDARD_DEVIATION 5.51 • n=4 Participants • The 3 participants treated with multiple doses of MGD014 were also treated with single doses of MGD014 at 10, 100 and 300 mg, respectively
|
56.7 years
STANDARD_DEVIATION 7.09 • n=21 Participants • The 3 participants treated with multiple doses of MGD014 were also treated with single doses of MGD014 at 10, 100 and 300 mg, respectively
|
41.0 years
STANDARD_DEVIATION 10.82 • n=8 Participants • The 3 participants treated with multiple doses of MGD014 were also treated with single doses of MGD014 at 10, 100 and 300 mg, respectively
|
33.7 years
STANDARD_DEVIATION 5.86 • n=8 Participants • The 3 participants treated with multiple doses of MGD014 were also treated with single doses of MGD014 at 10, 100 and 300 mg, respectively
|
42.3 years
STANDARD_DEVIATION 17.10 • n=24 Participants • The 3 participants treated with multiple doses of MGD014 were also treated with single doses of MGD014 at 10, 100 and 300 mg, respectively
|
44.4 years
STANDARD_DEVIATION 11.00 • n=42 Participants • The 3 participants treated with multiple doses of MGD014 were also treated with single doses of MGD014 at 10, 100 and 300 mg, respectively
|
|
Sex: Female, Male
Single dose · 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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Sex: Female, Male
Single dose · Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
21 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
19 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
13 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
3 participants
n=4 Participants
|
3 participants
n=21 Participants
|
3 participants
n=8 Participants
|
3 participants
n=8 Participants
|
3 participants
n=24 Participants
|
3 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: up to 77 daysSafety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of study drug administration through the End of Study visit.
Outcome measures
| Measure |
MGD014 0.1 Micrograms/Kilogram (mcg/kg)
n=1 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 0.3 mcg/kg
n=1 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 1.0 mcg/kg
n=4 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 3.0 mcg/kg
n=3 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 10.0 mcg/kg
n=3 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 30.0 mcg/kg
n=3 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 100.0 mcg/kg
n=3 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 300.0 mcg/kg
n=3 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 300.0 mcg/kg Multiple Doses
n=3 Participants
2-hour infusion every 2 weeks for 3 infusions
MGD014: HIV-1 x CD3 bispecific DART molecule
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emerging Adverse Events
|
1 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Study Day 0 to 42AUCinf, area under the concentration-time curve from the time of dose extrapolated to time infinity and reflects total drug exposure
Outcome measures
| Measure |
MGD014 0.1 Micrograms/Kilogram (mcg/kg)
n=1 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 0.3 mcg/kg
n=1 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 1.0 mcg/kg
n=4 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 3.0 mcg/kg
n=3 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 10.0 mcg/kg
n=3 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 30.0 mcg/kg
n=3 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 100.0 mcg/kg
n=3 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 300.0 mcg/kg
n=6 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 300.0 mcg/kg Multiple Doses
2-hour infusion every 2 weeks for 3 infusions
MGD014: HIV-1 x CD3 bispecific DART molecule
|
|---|---|---|---|---|---|---|---|---|---|
|
AUC Inf: Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity of MGD014
|
134 mcg/L*hr
not calculable for single participant
|
313 mcg/L*hr
not calculable for single participant
|
2610 mcg/L*hr
Interval 1230.0 to 3990.0
|
6360 mcg/L*hr
Interval 5420.0 to 7300.0
|
22300 mcg/L*hr
Interval 20600.0 to 23900.0
|
50900 mcg/L*hr
Interval 43600.0 to 58200.0
|
170000 mcg/L*hr
Interval 129000.0 to 210000.0
|
497000 mcg/L*hr
Interval 445000.0 to 549000.0
|
—
|
SECONDARY outcome
Timeframe: Study Day 0Cmax is the maximum (or peak) serum concentration of a drug in the body after the drug has been administered
Outcome measures
| Measure |
MGD014 0.1 Micrograms/Kilogram (mcg/kg)
n=1 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 0.3 mcg/kg
n=1 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 1.0 mcg/kg
n=4 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 3.0 mcg/kg
n=3 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 10.0 mcg/kg
n=3 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 30.0 mcg/kg
n=3 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 100.0 mcg/kg
n=3 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 300.0 mcg/kg
n=6 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 300.0 mcg/kg Multiple Doses
2-hour infusion every 2 weeks for 3 infusions
MGD014: HIV-1 x CD3 bispecific DART molecule
|
|---|---|---|---|---|---|---|---|---|---|
|
Cmax: Maximum Plasma Concentration
|
2.9 mcg/L
Not calculable for 1 participant
|
5.8 mcg/L
Not calculable for 1 participant
|
24.5 mcg/L
Interval 13.7 to 35.3
|
67.7 mcg/L
Interval 50.3 to 85.1
|
181 mcg/L
Interval 161.0 to 200.0
|
469 mcg/L
Interval 390.0 to 548.0
|
1640 mcg/L
Interval 1130.0 to 2160.0
|
5288.4 mcg/L
Interval 4590.0 to 5870.0
|
—
|
SECONDARY outcome
Timeframe: Study Day 0Tmax is the time it takes a drug to reach the maximum concentration
Outcome measures
| Measure |
MGD014 0.1 Micrograms/Kilogram (mcg/kg)
n=1 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 0.3 mcg/kg
n=1 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 1.0 mcg/kg
n=4 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 3.0 mcg/kg
n=3 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 10.0 mcg/kg
n=3 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 30.0 mcg/kg
n=3 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 100.0 mcg/kg
n=3 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 300.0 mcg/kg
n=6 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 300.0 mcg/kg Multiple Doses
2-hour infusion every 2 weeks for 3 infusions
MGD014: HIV-1 x CD3 bispecific DART molecule
|
|---|---|---|---|---|---|---|---|---|---|
|
Tmax: Time to Maximum Concentration
|
3.0 hours
not calculable for one participant
|
1.9 hours
not calculable for one participant
|
2.4 hours
Interval 1.6 to 3.1
|
2.0 hours
Interval 1.9 to 2.0
|
2.7 hours
Interval 1.9 to 3.4
|
1.9 hours
Interval 1.9 to 2.0
|
2.6 hours
Interval 1.9 to 3.4
|
2.5 hours
Interval 2.0 to 2.9
|
—
|
SECONDARY outcome
Timeframe: Study Day 14Population: Mean trough concentration for the 300 mcg/kg dose is from the first MGD014 infusion (taken at Day 14) for participants (n=3) in Part 2 only. Trough concentration is not applicable for single-dose cohorts.
a trough level or trough concentration (Ctrough) is the concentration reached by a drug immediately before the next dose is administered,
Outcome measures
| Measure |
MGD014 0.1 Micrograms/Kilogram (mcg/kg)
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 0.3 mcg/kg
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 1.0 mcg/kg
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 3.0 mcg/kg
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 10.0 mcg/kg
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 30.0 mcg/kg
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 100.0 mcg/kg
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 300.0 mcg/kg
n=3 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 300.0 mcg/kg Multiple Doses
2-hour infusion every 2 weeks for 3 infusions
MGD014: HIV-1 x CD3 bispecific DART molecule
|
|---|---|---|---|---|---|---|---|---|---|
|
Ctrough: Trough Level Concentration
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
320 mcg/L
Interval 252.0 to 338.0
|
—
|
SECONDARY outcome
Timeframe: Study Day 0 to 42Total body clearance of the drug from plasma of MGD014
Outcome measures
| Measure |
MGD014 0.1 Micrograms/Kilogram (mcg/kg)
n=1 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 0.3 mcg/kg
n=1 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 1.0 mcg/kg
n=4 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 3.0 mcg/kg
n=3 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 10.0 mcg/kg
n=3 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 30.0 mcg/kg
n=3 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 100.0 mcg/kg
n=3 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 300.0 mcg/kg
n=6 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 300.0 mcg/kg Multiple Doses
2-hour infusion every 2 weeks for 3 infusions
MGD014: HIV-1 x CD3 bispecific DART molecule
|
|---|---|---|---|---|---|---|---|---|---|
|
Clearance
|
0.04 L/hr
not calculable for one participant
|
0.07 L/hr
not calculable for one participant
|
0.03 L/hr
Interval 0.02 to 0.04
|
0.05 L/hr
Interval 0.04 to 0.05
|
0.04 L/hr
Interval 0.04 to 0.05
|
0.04 L/hr
Interval 0.04 to 0.05
|
0.05 L/hr
Interval 0.04 to 0.06
|
0.05 L/hr
Interval 0.05 to 0.06
|
—
|
SECONDARY outcome
Timeframe: Study Day 1, 2, 7, 14, 21, 28, and 42 (single infusion) and Study Day 1, 3, 14, 28, 42, and 77 (multiple infusions)The ratio of the total quantity of drug in the body to drug plasma concentration during the elimination
Outcome measures
| Measure |
MGD014 0.1 Micrograms/Kilogram (mcg/kg)
n=1 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 0.3 mcg/kg
n=1 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 1.0 mcg/kg
n=4 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 3.0 mcg/kg
n=3 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 10.0 mcg/kg
n=3 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 30.0 mcg/kg
n=3 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 100.0 mcg/kg
n=3 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 300.0 mcg/kg
n=6 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 300.0 mcg/kg Multiple Doses
2-hour infusion every 2 weeks for 3 infusions
MGD014: HIV-1 x CD3 bispecific DART molecule
|
|---|---|---|---|---|---|---|---|---|---|
|
Vz: Terminal Phase Volume of Distribution of MGD014
|
2.1 liters
not calculable for one participant
|
4.1 liters
not calculable for one participant.
|
8.7 liters
Interval 6.2 to 11.2
|
19.7 liters
Interval 14.2 to 25.2
|
17.5 liters
Interval 16.9 to 18.2
|
17.4 liters
Interval 15.4 to 19.3
|
21.6 liters
Interval 16.9 to 26.2
|
15.8 liters
Interval 9.1 to 22.5
|
—
|
SECONDARY outcome
Timeframe: Study Day 0 to Study Day 42Population: Average terminal half-life did not include participants in Part 2 (n=3) due to a shortened PK schedule that did not support estimation of half-life
The half-life is the amount of time required for 50% of the drug to be removed from the body
Outcome measures
| Measure |
MGD014 0.1 Micrograms/Kilogram (mcg/kg)
n=1 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 0.3 mcg/kg
n=1 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 1.0 mcg/kg
n=4 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 3.0 mcg/kg
n=3 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 10.0 mcg/kg
n=3 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 30.0 mcg/kg
n=3 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 100.0 mcg/kg
n=3 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 300.0 mcg/kg
n=6 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 300.0 mcg/kg Multiple Doses
2-hour infusion every 2 weeks for 3 infusions
MGD014: HIV-1 x CD3 bispecific DART molecule
|
|---|---|---|---|---|---|---|---|---|---|
|
Terminal Half Life of MGD014
|
32.0 hours
not calculable for one participant
|
38.6 hours
not calculable for one participant
|
244 hours
Interval 136.0 to 351.0
|
300 hours
Interval 227.0 to 373.0
|
295 hours
Interval 266.0 to 323.0
|
282 hours
Interval 276.0 to 288.0
|
285 hours
Interval 269.0 to 300.0
|
295 hours
Interval 289.0 to 305.0
|
—
|
SECONDARY outcome
Timeframe: Study Day 1, 14, 28 and 42 (single infusion) and Study Day 1, 14, 28 and 77 (multiple infusions)Number of participants with antidrug antibodies to MGD014
Outcome measures
| Measure |
MGD014 0.1 Micrograms/Kilogram (mcg/kg)
n=1 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 0.3 mcg/kg
n=1 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 1.0 mcg/kg
n=4 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 3.0 mcg/kg
n=3 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 10.0 mcg/kg
n=3 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 30.0 mcg/kg
n=3 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 100.0 mcg/kg
n=3 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 300.0 mcg/kg
n=6 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 300.0 mcg/kg Multiple Doses
2-hour infusion every 2 weeks for 3 infusions
MGD014: HIV-1 x CD3 bispecific DART molecule
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants That Developed Antidrug Antibodies to MGD014
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Study Day 1, 2 and 7 (single infusion) and Study Day 1, 3, 14 and 28 (multiple infusions)Number of participants with increased cytokine levels from baseline after MGD014 administration. This safety measure compares serum cytokine levels obtained prior to dosing with levels obtained after dosing. Increased cytokines can be a measure of T-cell activation in response to MGD014 binding. Cytokines analyzed included interferon-gamma, tumor necrosis factor-alpha, interleukin (IL)2, IL-5, IL-6, and IL-10.
Outcome measures
| Measure |
MGD014 0.1 Micrograms/Kilogram (mcg/kg)
n=1 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 0.3 mcg/kg
n=1 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 1.0 mcg/kg
n=4 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 3.0 mcg/kg
n=3 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 10.0 mcg/kg
n=3 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 30.0 mcg/kg
n=3 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 100.0 mcg/kg
n=3 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 300.0 mcg/kg
n=6 Participants
a single 2-hour infusion
MGD014: HIV-1 x CD3 bispecific DART molecule
|
MGD014 300.0 mcg/kg Multiple Doses
2-hour infusion every 2 weeks for 3 infusions
MGD014: HIV-1 x CD3 bispecific DART molecule
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Increased Cytokine Levels
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
Adverse Events
MGD014 0.1 mcg/kg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
MGD014 0.3 mcg/kg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
MGD014 1.0 mcg/kg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
MGD014 3.0 mcg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
MGD014 10.0 mcg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
MGD014 30 mcg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
MGD014 100 mcg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
MGD014 300 mcg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Multiple Dose MGD014 300 mcg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MGD014 0.1 mcg/kg
n=1 participants at risk
Single infusion of MGD014
|
MGD014 0.3 mcg/kg
n=1 participants at risk
Single infusion of MGD014
|
MGD014 1.0 mcg/kg
n=4 participants at risk
Single infusion of MGD014
|
MGD014 3.0 mcg/kg
n=3 participants at risk
Single infusion of MGD014
|
MGD014 10.0 mcg/kg
n=3 participants at risk
Single infusion of MGD014
|
MGD014 30 mcg/kg
n=3 participants at risk
Single infusion of MGD014
|
MGD014 100 mcg/kg
n=3 participants at risk
Single infusion of MGD014
|
MGD014 300 mcg/kg
n=3 participants at risk
Single infusion of MGD014
|
Multiple Dose MGD014 300 mcg/kg
n=3 participants at risk
Infusion every 2 weeks for 3 infusions.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/4 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/4 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/1 • up to 19 weeks
|
25.0%
1/4 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/1 • up to 19 weeks
|
25.0%
1/4 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/1 • up to 19 weeks
|
25.0%
1/4 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/1 • up to 19 weeks
|
25.0%
1/4 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/1 • up to 19 weeks
|
25.0%
1/4 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/4 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
|
General disorders
Application site erythema
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/4 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
|
General disorders
Fatigue
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/1 • up to 19 weeks
|
25.0%
1/4 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/1 • up to 19 weeks
|
100.0%
1/1 • up to 19 weeks
|
25.0%
1/4 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/1 • up to 19 weeks
|
100.0%
1/1 • up to 19 weeks
|
50.0%
2/4 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
|
General disorders
Infusion site bruising
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/4 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
66.7%
2/3 • up to 19 weeks
|
|
General disorders
Feeling hot
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/4 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
|
General disorders
Pyrexia
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/4 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
|
General disorders
Vessel puncture site haemorrhage
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/4 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/4 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/4 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/4 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/4 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
|
Injury, poisoning and procedural complications
Eye contusion
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/4 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/1 • up to 19 weeks
|
25.0%
1/4 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/4 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/4 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/4 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
|
Investigations
Electrocardiogram QT prolonged
|
100.0%
1/1 • up to 19 weeks
|
100.0%
1/1 • up to 19 weeks
|
0.00%
0/4 • up to 19 weeks
|
66.7%
2/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
|
Investigations
Blood creatinine increased
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/4 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
|
Investigations
Blood pressure increased
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/4 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/4 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/4 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/4 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/4 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/4 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/4 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/1 • up to 19 weeks
|
50.0%
2/4 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
|
Nervous system disorders
Seizure
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/1 • up to 19 weeks
|
25.0%
1/4 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/4 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
|
Psychiatric disorders
Emotional distress
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/4 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/4 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/4 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/4 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/4 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/4 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/4 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/4 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/4 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
|
Vascular disorders
Flushing
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/4 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/1 • up to 19 weeks
|
0.00%
0/4 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
33.3%
1/3 • up to 19 weeks
|
0.00%
0/3 • up to 19 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60