Trial Outcomes & Findings for Safety, Tolerability, and Pharmacokinetics of IXT-m200 (NCT NCT05027451)
NCT ID: NCT05027451
Last Updated: 2023-06-01
Results Overview
Physical examinations
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
9 participants
Primary outcome timeframe
127 days
Results posted on
2023-06-01
Participant Flow
Participants underwent screening procedures to check eligibility criteria within 30 days prior to randomization.
Participant milestones
| Measure |
IXT-m200
3 g of IXT-m200 given once by 30-min intravenous infusion
IXT-m200: Anti-methamphetamine chimeric monoclonal antibody (mAb)
|
Placebo
Normal saline
Placebo: Normal saline
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
2
|
|
Overall Study
COMPLETED
|
6
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
IXT-m200
3 g of IXT-m200 given once by 30-min intravenous infusion
IXT-m200: Anti-methamphetamine chimeric monoclonal antibody (mAb)
|
Placebo
Normal saline
Placebo: Normal saline
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Safety, Tolerability, and Pharmacokinetics of IXT-m200
Baseline characteristics by cohort
| Measure |
IXT-m200
n=7 Participants
3 g of IXT-m200 given once by 30-min intravenous infusion
IXT-m200: Anti-methamphetamine chimeric monoclonal antibody (mAb)
|
Placebo
n=2 Participants
Normal saline
Placebo: Normal saline
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.9 years
STANDARD_DEVIATION 8.75 • n=5 Participants
|
42.5 years
STANDARD_DEVIATION 13.44 • n=7 Participants
|
42.0 years
STANDARD_DEVIATION 8.94 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
2 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
BMI
|
29.7 kg/m^2
STANDARD_DEVIATION 2.67 • n=5 Participants
|
24.38 kg/m^2
STANDARD_DEVIATION 4.91 • n=7 Participants
|
28.52 kg/m^2
STANDARD_DEVIATION 3.72 • n=5 Participants
|
|
Weight
|
87.41 kg
STANDARD_DEVIATION 9.83 • n=5 Participants
|
64 kg
STANDARD_DEVIATION 4.1 • n=7 Participants
|
82.21 kg
STANDARD_DEVIATION 13.46 • n=5 Participants
|
|
Height
|
171.5 cm
STANDARD_DEVIATION 5.91 • n=5 Participants
|
163 cm
STANDARD_DEVIATION 11.31 • n=7 Participants
|
169.59 cm
STANDARD_DEVIATION 7.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: 127 daysPopulation: All participants
Physical examinations
Outcome measures
| Measure |
IXT-m200
n=7 Participants
3 g of IXT-m200 given once by 30-min intravenous infusion
IXT-m200: Anti-methamphetamine chimeric monoclonal antibody (mAb)
|
Placebo
n=2 Participants
Normal saline
Placebo: Normal saline
|
|---|---|---|
|
Number of Participants With Treatment-related Adverse Events (AEs) Assessed by Physical Examinations
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 127 daysPopulation: All participants
Blood pressure, heart rate, and temperature
Outcome measures
| Measure |
IXT-m200
n=7 Participants
3 g of IXT-m200 given once by 30-min intravenous infusion
IXT-m200: Anti-methamphetamine chimeric monoclonal antibody (mAb)
|
Placebo
n=2 Participants
Normal saline
Placebo: Normal saline
|
|---|---|---|
|
Number of Participants With Treatment-related AEs Assessed by Vital Signs
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 30 min post-dose completionPopulation: All participants
Electrocardiogram
Outcome measures
| Measure |
IXT-m200
n=7 Participants
3 g of IXT-m200 given once by 30-min intravenous infusion
IXT-m200: Anti-methamphetamine chimeric monoclonal antibody (mAb)
|
Placebo
n=2 Participants
Normal saline
Placebo: Normal saline
|
|---|---|---|
|
Number of Participants With Treatment-related AEs Assessed by ECG
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 64 daysPopulation: All participants
Clinical laboratory testing
Outcome measures
| Measure |
IXT-m200
n=7 Participants
3 g of IXT-m200 given once by 30-min intravenous infusion
IXT-m200: Anti-methamphetamine chimeric monoclonal antibody (mAb)
|
Placebo
n=2 Participants
Normal saline
Placebo: Normal saline
|
|---|---|---|
|
Number of Participants With Treatment-related AEs Assessed by Clinical Laboratory Testing
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 127 daysPopulation: All participants receiving IXT-m200
IXT-m200 concentrations over time
Outcome measures
| Measure |
IXT-m200
n=7 Participants
3 g of IXT-m200 given once by 30-min intravenous infusion
IXT-m200: Anti-methamphetamine chimeric monoclonal antibody (mAb)
|
Placebo
Normal saline
Placebo: Normal saline
|
|---|---|---|
|
Time Course of IXT-m200 Concentrations
Pre-dose
|
0 mg/L
Standard Deviation 0
|
—
|
|
Time Course of IXT-m200 Concentrations
1 hr post-dose
|
728 mg/L
Standard Deviation 157
|
—
|
|
Time Course of IXT-m200 Concentrations
4 hr post-dose
|
705 mg/L
Standard Deviation 100
|
—
|
|
Time Course of IXT-m200 Concentrations
8 hr post-dose
|
632 mg/L
Standard Deviation 104
|
—
|
|
Time Course of IXT-m200 Concentrations
Day 2
|
632 mg/L
Standard Deviation 132
|
—
|
|
Time Course of IXT-m200 Concentrations
Day 8
|
316 mg/L
Standard Deviation 62.6
|
—
|
|
Time Course of IXT-m200 Concentrations
Day 15
|
257 mg/L
Standard Deviation 31
|
—
|
|
Time Course of IXT-m200 Concentrations
Day 22
|
194 mg/L
Standard Deviation 48
|
—
|
|
Time Course of IXT-m200 Concentrations
Day 29
|
155 mg/L
Standard Deviation 50.9
|
—
|
|
Time Course of IXT-m200 Concentrations
Day 36
|
109 mg/L
Standard Deviation 22.5
|
—
|
|
Time Course of IXT-m200 Concentrations
Day 43
|
84.1 mg/L
Standard Deviation 14.8
|
—
|
|
Time Course of IXT-m200 Concentrations
Day 64
|
37.4 mg/L
Standard Deviation 12.2
|
—
|
|
Time Course of IXT-m200 Concentrations
Day 85
|
13.5 mg/L
Standard Deviation 4.3
|
—
|
|
Time Course of IXT-m200 Concentrations
Day 106
|
6.92 mg/L
Standard Deviation 1.98
|
—
|
|
Time Course of IXT-m200 Concentrations
Day 127
|
3.65 mg/L
Standard Deviation 1.4
|
—
|
Adverse Events
IXT-m200
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
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 |
IXT-m200
n=7 participants at risk
3 g of IXT-m200 given once by 30-min intravenous infusion
IXT-m200: Anti-methamphetamine chimeric monoclonal antibody (mAb)
|
Placebo
n=2 participants at risk
Normal saline
Placebo: Normal saline
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/7 • Adverse event data were collected following the start of administration of study drug on Day 1 through the final study visit on Day 127.
AE data were collected at study visits or between visits if participants informed the site by phone or visit.
|
50.0%
1/2 • Number of events 1 • Adverse event data were collected following the start of administration of study drug on Day 1 through the final study visit on Day 127.
AE data were collected at study visits or between visits if participants informed the site by phone or visit.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
1/7 • Number of events 1 • Adverse event data were collected following the start of administration of study drug on Day 1 through the final study visit on Day 127.
AE data were collected at study visits or between visits if participants informed the site by phone or visit.
|
0.00%
0/2 • Adverse event data were collected following the start of administration of study drug on Day 1 through the final study visit on Day 127.
AE data were collected at study visits or between visits if participants informed the site by phone or visit.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/7 • Adverse event data were collected following the start of administration of study drug on Day 1 through the final study visit on Day 127.
AE data were collected at study visits or between visits if participants informed the site by phone or visit.
|
50.0%
1/2 • Number of events 1 • Adverse event data were collected following the start of administration of study drug on Day 1 through the final study visit on Day 127.
AE data were collected at study visits or between visits if participants informed the site by phone or visit.
|
|
Investigations
SARS-CoV-2 antibody test positive
|
28.6%
2/7 • Number of events 2 • Adverse event data were collected following the start of administration of study drug on Day 1 through the final study visit on Day 127.
AE data were collected at study visits or between visits if participants informed the site by phone or visit.
|
0.00%
0/2 • Adverse event data were collected following the start of administration of study drug on Day 1 through the final study visit on Day 127.
AE data were collected at study visits or between visits if participants informed the site by phone or visit.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
1/7 • Number of events 1 • Adverse event data were collected following the start of administration of study drug on Day 1 through the final study visit on Day 127.
AE data were collected at study visits or between visits if participants informed the site by phone or visit.
|
0.00%
0/2 • Adverse event data were collected following the start of administration of study drug on Day 1 through the final study visit on Day 127.
AE data were collected at study visits or between visits if participants informed the site by phone or visit.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
14.3%
1/7 • Number of events 1 • Adverse event data were collected following the start of administration of study drug on Day 1 through the final study visit on Day 127.
AE data were collected at study visits or between visits if participants informed the site by phone or visit.
|
0.00%
0/2 • Adverse event data were collected following the start of administration of study drug on Day 1 through the final study visit on Day 127.
AE data were collected at study visits or between visits if participants informed the site by phone or visit.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
14.3%
1/7 • Number of events 1 • Adverse event data were collected following the start of administration of study drug on Day 1 through the final study visit on Day 127.
AE data were collected at study visits or between visits if participants informed the site by phone or visit.
|
0.00%
0/2 • Adverse event data were collected following the start of administration of study drug on Day 1 through the final study visit on Day 127.
AE data were collected at study visits or between visits if participants informed the site by phone or visit.
|
|
General disorders
Injection site haemorrhage
|
14.3%
1/7 • Number of events 1 • Adverse event data were collected following the start of administration of study drug on Day 1 through the final study visit on Day 127.
AE data were collected at study visits or between visits if participants informed the site by phone or visit.
|
0.00%
0/2 • Adverse event data were collected following the start of administration of study drug on Day 1 through the final study visit on Day 127.
AE data were collected at study visits or between visits if participants informed the site by phone or visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI may prepare and submit manuscripts or slide shows based on Study Data. Such manuscripts or slide shows shall be submitted to Sponsor for review, at which time these may be approved or rejected. PI will not release those that are rejected by Sponsor. One investigator may be identified as an author or co-author of Sponsor-sponsored publications resulting from this study.
- Publication restrictions are in place
Restriction type: OTHER