Trial Outcomes & Findings for Study to Compare the Anti-tetanus Neutralizing Antibody Titers and Safety of TNM002 Injection With Human Tetanus Immunoglobulin or Placebo in Adult Volunteers (NCT NCT05625477)

NCT ID: NCT05625477

Last Updated: 2025-09-16

Results Overview

The increase of anti-tetanus neutralizing antibody titers were defined as ΔTiters, calculated as the post-administration antibody titers minus the baseline antibody titers. The antibody protective level is ΔTiters \>0.01 IU/mL.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 240 participants
• Primary outcome timeframe: At 24 hours post-dose
• Results posted on: 2025-09-16

Participant Flow

A total of 240 adult participants were recruited from 4 study sites in China, from 18 April 2022 to 27 May 2022.

There were 402 participants excluded from the trial before assignment to any arm, primarily due to failure to meet eligibility criteria (369 participants) and other (33).

Participant milestones

Measure	TNM002 5 mg Double blind, a single intramuscular injection on Day 1	TNM002 10 mg Double blind, a single intramuscular injection on Day 1	TNM002 15 mg Double blind, a single intramuscular injection on Day 1	HTIG Double blind, a single intramuscular injection of Human Tetanus Immunoglobulin (HTIG) 250 IU on Day 1	Placebo Double blind, a single intramuscular injection on Day 1
Overall Study STARTED	61	61	29	59	30
Overall Study COMPLETED	58	59	28	58	30
Overall Study NOT COMPLETED	3	2	1	1	0

Reasons for withdrawal

Measure	TNM002 5 mg Double blind, a single intramuscular injection on Day 1	TNM002 10 mg Double blind, a single intramuscular injection on Day 1	TNM002 15 mg Double blind, a single intramuscular injection on Day 1	HTIG Double blind, a single intramuscular injection of Human Tetanus Immunoglobulin (HTIG) 250 IU on Day 1	Placebo Double blind, a single intramuscular injection on Day 1
Overall Study Lost to Follow-up	2	2	1	1	0
Overall Study Covid quarantine	1	0	0	0	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	TNM002 5 mg n=61 Participants Double blind, a single intramuscular injection on Day 1	TNM002 10 mg n=61 Participants Double blind, a single intramuscular injection on Day 1	TNM002 15 mg n=29 Participants Double blind, a single intramuscular injection on Day 1	HTIG n=59 Participants Double blind, a single intramuscular injection of Human Tetanus Immunoglobulin (HTIG) 250 IU on Day 1	Placebo n=30 Participants Double blind, a single intramuscular injection on Day 1	Total n=240 Participants Total of all reporting groups
Age, Continuous	40 years of age n=61 Participants	38 years of age n=61 Participants	33 years of age n=29 Participants	36 years of age n=59 Participants	38.5 years of age n=30 Participants	38 years of age n=240 Participants
Sex: Female, Male Female	20 Participants n=61 Participants	21 Participants n=61 Participants	8 Participants n=29 Participants	26 Participants n=59 Participants	13 Participants n=30 Participants	88 Participants n=240 Participants
Sex: Female, Male Male	41 Participants n=61 Participants	40 Participants n=61 Participants	21 Participants n=29 Participants	33 Participants n=59 Participants	17 Participants n=30 Participants	152 Participants n=240 Participants
Race and Ethnicity Not Collected	—	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Anti-tetanus neutralizing antibody titers	0.4982 IU/mL STANDARD_DEVIATION 2.1697 • n=61 Participants • The administration of placebo precluded measurable antibody response generation, thus participants in the placebo group were excluded from the efficacy analyses regarding the changes in antibody titers. Baseline antibody titers were measured for placebo participants solely for demographic balance assessment and assay validation purposes.	0.0916 IU/mL STANDARD_DEVIATION 0.3253 • n=61 Participants • The administration of placebo precluded measurable antibody response generation, thus participants in the placebo group were excluded from the efficacy analyses regarding the changes in antibody titers. Baseline antibody titers were measured for placebo participants solely for demographic balance assessment and assay validation purposes.	0.0362 IU/mL STANDARD_DEVIATION 0.0583 • n=29 Participants • The administration of placebo precluded measurable antibody response generation, thus participants in the placebo group were excluded from the efficacy analyses regarding the changes in antibody titers. Baseline antibody titers were measured for placebo participants solely for demographic balance assessment and assay validation purposes.	0.0596 IU/mL STANDARD_DEVIATION 0.2530 • n=59 Participants • The administration of placebo precluded measurable antibody response generation, thus participants in the placebo group were excluded from the efficacy analyses regarding the changes in antibody titers. Baseline antibody titers were measured for placebo participants solely for demographic balance assessment and assay validation purposes.	0.0738 IU/mL STANDARD_DEVIATION 0.2194 • n=30 Participants • The administration of placebo precluded measurable antibody response generation, thus participants in the placebo group were excluded from the efficacy analyses regarding the changes in antibody titers. Baseline antibody titers were measured for placebo participants solely for demographic balance assessment and assay validation purposes.	0.1782 IU/mL STANDARD_DEVIATION 1.125 • n=240 Participants • The administration of placebo precluded measurable antibody response generation, thus participants in the placebo group were excluded from the efficacy analyses regarding the changes in antibody titers. Baseline antibody titers were measured for placebo participants solely for demographic balance assessment and assay validation purposes.

PRIMARY outcome

Timeframe: At 24 hours post-dose

Population: The analysis plan prespecified that placebo group data would not be collected for this outcome measure related to the anti-tetanus antibody level, as the administration of placebo precludes the generation of measurable antibody responses. Therefore, placebo recipients were analytically excluded from the efficacy analysis of antibody titer changes. The active control (HTIG) serves as the comparator for efficacy assessments, while the placebo group is retained solely for safety evaluations.

The increase of anti-tetanus neutralizing antibody titers were defined as ΔTiters, calculated as the post-administration antibody titers minus the baseline antibody titers. The antibody protective level is ΔTiters >0.01 IU/mL.

Outcome measures

Measure	TNM002 5 mg n=61 Participants Double blind, a single intramuscular injection on Day 1	TNM002 10 mg n=61 Participants Double blind, a single intramuscular injection on Day 1	TNM002 15 mg n=29 Participants Double blind, a single intramuscular injection on Day 1	HTIG n=59 Participants Double blind, a single intramuscular injection of Human Tetanus Immunoglobulin (HTIG) 250 IU on Day 1	Placebo Double blind, a single intramuscular injection on Day 1
Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level	56 Participants	61 Participants	29 Participants	48 Participants	0 Participants

SECONDARY outcome

Timeframe: At 24 hours, 48 hours, and on Days 3, 7, 21, 30 and 90 post-dose

Population: The analysis plan prespecified that placebo group data would not be collected for this outcome measure related to the anti-tetanus antibody level, as the administration of placebo precludes the generation of measurable antibody responses. Therefore, placebo recipients were analytically excluded from the efficacy analysis of antibody titer changes. The active control (HTIG) serves as the comparator for efficacy assessments, while the placebo group is retained solely for safety evaluations.

The increase of anti-tetanus neutralizing antibody titers were defined as ΔTiters, calculated as the post-administration antibody titers minus the baseline antibody titers. The antibody protective level is ΔTiters >0.01 IU/mL.

The number of participants with evaluable anti-tetanus neutralizing antibody data were provided at each post-dose timepoint.

Outcome measures

Measure	TNM002 5 mg n=61 Participants Double blind, a single intramuscular injection on Day 1	TNM002 10 mg n=61 Participants Double blind, a single intramuscular injection on Day 1	TNM002 15 mg n=29 Participants Double blind, a single intramuscular injection on Day 1	HTIG n=59 Participants Double blind, a single intramuscular injection of Human Tetanus Immunoglobulin (HTIG) 250 IU on Day 1	Placebo Double blind, a single intramuscular injection on Day 1
Change From Baseline in Anti-tetanus Neutralizing Antibody Titers (∆Titers) Day 7	0.1264 IU/mL Interval 0.1057 to 0.1511	0.2655 IU/mL Interval 0.2288 to 0.3081	0.4786 IU/mL Interval 0.4126 to 0.5551	0.0392 IU/mL Interval 0.0336 to 0.0456	—
Change From Baseline in Anti-tetanus Neutralizing Antibody Titers (∆Titers) 24 hours	0.0450 IU/mL Interval 0.0338 to 0.0597	0.1095 IU/mL Interval 0.0844 to 0.1418	0.2094 IU/mL Interval 0.1637 to 0.2677	0.0200 IU/mL Interval 0.0158 to 0.0253	—
Change From Baseline in Anti-tetanus Neutralizing Antibody Titers (∆Titers) 48 hours	0.0687 IU/mL Interval 0.0529 to 0.0889	0.1665 IU/mL Interval 0.1338 to 0.2071	0.3007 IU/mL Interval 0.2446 to 0.3695	0.0295 IU/mL Interval 0.024 to 0.0362	—
Change From Baseline in Anti-tetanus Neutralizing Antibody Titers (∆Titers) Day 3	0.0957 IU/mL Interval 0.0771 to 0.1188	0.2057 IU/mL Interval 0.1691 to 0.2503	0.3835 IU/mL Interval 0.3201 to 0.4593	0.0348 IU/mL Interval 0.0288 to 0.0419	—
Change From Baseline in Anti-tetanus Neutralizing Antibody Titers (∆Titers) Day 21	0.1282 IU/mL Interval 0.1154 to 0.1425	0.2563 IU/mL Interval 0.2357 to 0.2788	0.3898 IU/mL Interval 0.3549 to 0.428	0.0274 IU/mL Interval 0.023 to 0.0327	—
Change From Baseline in Anti-tetanus Neutralizing Antibody Titers (∆Titers) Day 30	0.1058 IU/mL Interval 0.0959 to 0.1166	0.2119 IU/mL Interval 0.1946 to 0.2306	0.3217 IU/mL Interval 0.2943 to 0.3518	0.0214 IU/mL Interval 0.0187 to 0.0243	—
Change From Baseline in Anti-tetanus Neutralizing Antibody Titers (∆Titers) Day 90	0.0189 IU/mL Interval 0.016 to 0.0223	0.0381 IU/mL Interval 0.0338 to 0.043	0.0655 IU/mL Interval 0.0546 to 0.0785	0.0057 IU/mL Interval 0.0039 to 0.008	—

SECONDARY outcome

Timeframe: At 48 hours and on Days 3, 7, 21, 30, and 90 post-dose

Population: The analysis plan prespecified that placebo group data would not be collected for this outcome measure related to the anti-tetanus antibody level, as the administration of placebo precludes the generation of measurable antibody responses. Therefore, placebo recipients were analytically excluded from the efficacy analysis of antibody titer changes. The active control (HTIG) serves as the comparator for efficacy assessments, while the placebo group is retained solely for safety evaluations.

The increase of anti-tetanus neutralizing antibody titers were defined as ΔTiters, calculated as the post-administration antibody titers minus the baseline antibody titers. The antibody protective level is ΔTiters >0.01 IU/mL.

The number of participants with evaluable anti-tetanus neutralizing antibody data were provided at each post-dose timepoint.

Outcome measures

Measure	TNM002 5 mg n=61 Participants Double blind, a single intramuscular injection on Day 1	TNM002 10 mg n=61 Participants Double blind, a single intramuscular injection on Day 1	TNM002 15 mg n=29 Participants Double blind, a single intramuscular injection on Day 1	HTIG n=59 Participants Double blind, a single intramuscular injection of Human Tetanus Immunoglobulin (HTIG) 250 IU on Day 1	Placebo Double blind, a single intramuscular injection on Day 1
Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level 48 hours	58 Participants	61 Participants	29 Participants	55 Participants	—
Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level Day 3	61 Participants	61 Participants	29 Participants	57 Participants	—
Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level Day 7	61 Participants	61 Participants	29 Participants	59 Participants	—
Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level Day 21	60 Participants	61 Participants	29 Participants	57 Participants	—
Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level Day 30	59 Participants	61 Participants	29 Participants	56 Participants	—
Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level Day 90	48 Participants	58 Participants	28 Participants	18 Participants	—

SECONDARY outcome

Timeframe: Up to 105 (±7) days post dosing

Population: The analysis plan prespecified that placebo group data would not be collected for this outcome measure related to the anti-tetanus antibody level, as the administration of placebo precludes the generation of measurable antibody responses. Therefore, placebo recipients were analytically excluded from the efficacy analysis of antibody titer changes. The active control (HTIG) serves as the comparator for efficacy assessments, while the placebo group is retained solely for safety evaluations.

The increase of anti-tetanus neutralizing antibody titers were defined as ΔTiters, calculated as the post-administration antibody titers minus the baseline antibody titers. The antibody protective level is ΔTiters >0.01 IU/mL.

The number of participants with evaluable anti-tetanus neutralizing antibody data were provided at each post-dose timepoint.

Outcome measures

Measure	TNM002 5 mg n=61 Participants Double blind, a single intramuscular injection on Day 1	TNM002 10 mg n=61 Participants Double blind, a single intramuscular injection on Day 1	TNM002 15 mg n=29 Participants Double blind, a single intramuscular injection on Day 1	HTIG n=59 Participants Double blind, a single intramuscular injection of Human Tetanus Immunoglobulin (HTIG) 250 IU on Day 1	Placebo Double blind, a single intramuscular injection on Day 1
Duration of Anti-tetanus Neutralizing Antibody Titers Increasing From Baseline Over Protective Level Post-dose	NA Day Interval 2.0 to 112.0 More than half of the participants maintained antibody titers above protective level (0.01 IU/mL) through the end of the trial.	NA Day Interval 58.0 to 111.0 More than half of the participants maintained antibody titers above protective level (0.01 IU/mL) through the end of the trial.	NA Day Interval 31.0 to 108.0 More than half of the participants maintained antibody titers above protective level (0.01 IU/mL) through the end of the trial.	59 Day Interval 9.0 to 106.0	—

SECONDARY outcome

Timeframe: Up to 105 days post dosing

Population: All TNM002-treated participants had evaluable post-dose concentration data for the calculation of Cmax.

The peak serum concentration of TNM002 observed after administration.

Outcome measures

Measure	TNM002 5 mg n=61 Participants Double blind, a single intramuscular injection on Day 1	TNM002 10 mg n=61 Participants Double blind, a single intramuscular injection on Day 1	TNM002 15 mg n=29 Participants Double blind, a single intramuscular injection on Day 1	HTIG Double blind, a single intramuscular injection of Human Tetanus Immunoglobulin (HTIG) 250 IU on Day 1	Placebo Double blind, a single intramuscular injection on Day 1
Maximum Concentration (Cmax) of TNM002	460 ng/mL Geometric Coefficient of Variation 57.6	967 ng/mL Geometric Coefficient of Variation 52.6	1710 ng/mL Geometric Coefficient of Variation 34.5	—	—

SECONDARY outcome

Timeframe: Up to 105 days post dosing

Population: All TNM002-treated participants had evaluable post-dose concentration data for the calculation of Tmax.

The time point at which the Cmax is observed following TNM002 administration.

Outcome measures

Measure	TNM002 5 mg n=61 Participants Double blind, a single intramuscular injection on Day 1	TNM002 10 mg n=61 Participants Double blind, a single intramuscular injection on Day 1	TNM002 15 mg n=29 Participants Double blind, a single intramuscular injection on Day 1	HTIG Double blind, a single intramuscular injection of Human Tetanus Immunoglobulin (HTIG) 250 IU on Day 1	Placebo Double blind, a single intramuscular injection on Day 1
Time to Maximum Concentration (Tmax) of TNM002	312 hours Interval 72.0 to 698.0	311 hours Interval 72.0 to 698.0	144 hours Interval 72.0 to 481.0	—	—

SECONDARY outcome

Timeframe: Up to 105 days post dosing

Population: Five participants were exlucded from the analysis due to model fitting failure for t1/2.

The time required for the serum concentration of TNM002 to decrease by 50% during the elimination phase.

Outcome measures

Measure	TNM002 5 mg n=58 Participants Double blind, a single intramuscular injection on Day 1	TNM002 10 mg n=60 Participants Double blind, a single intramuscular injection on Day 1	TNM002 15 mg n=28 Participants Double blind, a single intramuscular injection on Day 1	HTIG Double blind, a single intramuscular injection of Human Tetanus Immunoglobulin (HTIG) 250 IU on Day 1	Placebo Double blind, a single intramuscular injection on Day 1
Elimination Half-life (t1/2) of TNM002	586 hours Interval 415.0 to 988.0	596 hours Interval 353.0 to 991.0	661 hours Interval 416.0 to 867.0	—	—

SECONDARY outcome

Timeframe: Up to 105 days post dosing

Population: All TNM002-treated participants had evaluable post-dose concentration data for AUC analysis.

The total drug exposure of TNM002 over a defined time period (from administration to the last measurable concentration), calculated as the integral of the serum concentration-time curve.

Outcome measures

Measure	TNM002 5 mg n=61 Participants Double blind, a single intramuscular injection on Day 1	TNM002 10 mg n=61 Participants Double blind, a single intramuscular injection on Day 1	TNM002 15 mg n=29 Participants Double blind, a single intramuscular injection on Day 1	HTIG Double blind, a single intramuscular injection of Human Tetanus Immunoglobulin (HTIG) 250 IU on Day 1	Placebo Double blind, a single intramuscular injection on Day 1
Area Under the Concentration-time Curve From Time 0 to t (AUC0-t) of TNM002	524000 h*ng/mL Standard Deviation 231000	1080000 h*ng/mL Standard Deviation 384000	1810000 h*ng/mL Standard Deviation 499000	—	—

SECONDARY outcome

Timeframe: Up to 105 days post dosing

Population: Five participants were exlucded from the analysis due to model fitting failure for AUC0-∞.

The total systemic exposure of TNM002 from administration until complete elimination, calculated by combining AUC0-t and the extrapolated area from the last measurable concentration to infinity.

Outcome measures

Measure	TNM002 5 mg n=58 Participants Double blind, a single intramuscular injection on Day 1	TNM002 10 mg n=60 Participants Double blind, a single intramuscular injection on Day 1	TNM002 15 mg n=28 Participants Double blind, a single intramuscular injection on Day 1	HTIG Double blind, a single intramuscular injection of Human Tetanus Immunoglobulin (HTIG) 250 IU on Day 1	Placebo Double blind, a single intramuscular injection on Day 1
Area Under the Concentration-time Curve From Time 0 to ∞ (AUC0-∞) of TNM002	589000 h*ng/mL Standard Deviation 244000	1180000 h*ng/mL Standard Deviation 416000	1990000 h*ng/mL Standard Deviation 559000	—	—

SECONDARY outcome

Timeframe: Up to 105 days post dosing

Population: All TNM002-treated participants had evaluable post-dose immunogenicity data for the ADA analysis.

The proportion of participants who developed anti-drug antibodies (ADA) against TNM002 during the course of the trial.

Outcome measures

Measure	TNM002 5 mg n=61 Participants Double blind, a single intramuscular injection on Day 1	TNM002 10 mg n=61 Participants Double blind, a single intramuscular injection on Day 1	TNM002 15 mg n=29 Participants Double blind, a single intramuscular injection on Day 1	HTIG Double blind, a single intramuscular injection of Human Tetanus Immunoglobulin (HTIG) 250 IU on Day 1	Placebo Double blind, a single intramuscular injection on Day 1
Positive Rate of ADA in Volunteers in TNM002 Groups	3 Participants	3 Participants	1 Participants	—	—

Adverse Events

TNM002 5 mg

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

TNM002 10 mg

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

TNM002 15 mg

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

HTIG

Serious events: 1 serious events

Other events: 32 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Measure	TNM002 5 mg n=61 participants at risk Double blind, a single intramuscular injection on Day 1	TNM002 10 mg n=61 participants at risk Double blind, a single intramuscular injection on Day 1	TNM002 15 mg n=29 participants at risk Double blind, a single intramuscular injection on Day 1	HTIG n=59 participants at risk Double blind, a single intramuscular injection of Human Tetanus Immunoglobulin (HTIG) 250 IU on Day 1	Placebo n=30 participants at risk Double blind, a single intramuscular injection on Day 1
Nervous system disorders Subdural hemorrhage	0.00% 0/61 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	0.00% 0/61 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	0.00% 0/29 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	1.7% 1/59 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	0.00% 0/30 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.

Other adverse events

Measure	TNM002 5 mg n=61 participants at risk Double blind, a single intramuscular injection on Day 1	TNM002 10 mg n=61 participants at risk Double blind, a single intramuscular injection on Day 1	TNM002 15 mg n=29 participants at risk Double blind, a single intramuscular injection on Day 1	HTIG n=59 participants at risk Double blind, a single intramuscular injection of Human Tetanus Immunoglobulin (HTIG) 250 IU on Day 1	Placebo n=30 participants at risk Double blind, a single intramuscular injection on Day 1
Investigations Blood triglycerides increased	9.8% 6/61 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	13.1% 8/61 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	6.9% 2/29 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	5.1% 3/59 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	16.7% 5/30 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.
Investigations Blood uric acid increased	9.8% 6/61 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	11.5% 7/61 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	0.00% 0/29 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	6.8% 4/59 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	6.7% 2/30 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.
Investigations Alanine aminotransferase	3.3% 2/61 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	1.6% 1/61 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	6.9% 2/29 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	3.4% 2/59 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	13.3% 4/30 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.
Investigations Bilirubin conjugated increased	1.6% 1/61 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	6.6% 4/61 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	0.00% 0/29 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	6.8% 4/59 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	0.00% 0/30 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.
Investigations Monocyte count increased	1.6% 1/61 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	3.3% 2/61 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	3.4% 1/29 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	5.1% 3/59 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	0.00% 0/30 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.
Investigations Red blood cells urine positive	4.9% 3/61 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	0.00% 0/61 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	3.4% 1/29 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	1.7% 1/59 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	0.00% 0/30 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.
Investigations Neutrophil count decreased	3.3% 2/61 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	3.3% 2/61 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	0.00% 0/29 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	1.7% 1/59 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	6.7% 2/30 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.
Investigations Aspartate aminotransferase increased	3.3% 2/61 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	0.00% 0/61 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	3.4% 1/29 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	1.7% 1/59 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	3.3% 1/30 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.
Investigations Blood cholesterol increased	1.6% 1/61 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	3.3% 2/61 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	0.00% 0/29 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	0.00% 0/59 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	0.00% 0/30 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.
Investigations Blood creatine phosphokinase increased	3.3% 2/61 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	0.00% 0/61 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	3.4% 1/29 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	1.7% 1/59 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	3.3% 1/30 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.
Investigations Blood glucose increased	3.3% 2/61 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	1.6% 1/61 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	0.00% 0/29 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	0.00% 0/59 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	0.00% 0/30 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.
Investigations Neutrophil count increased	3.3% 2/61 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	1.6% 1/61 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	0.00% 0/29 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	5.1% 3/59 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	3.3% 1/30 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/61 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	4.9% 3/61 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	0.00% 0/29 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	0.00% 0/59 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	3.3% 1/30 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.
Infections and infestations Upper respiratory tract infection	6.6% 4/61 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	1.6% 1/61 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	0.00% 0/29 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	1.7% 1/59 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	6.7% 2/30 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.
Investigations Lymphocyte count increased	1.6% 1/61 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	0.00% 0/61 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	3.4% 1/29 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	1.7% 1/59 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	0.00% 0/30 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.
Investigations Thrombocyte count decreased	1.6% 1/61 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	0.00% 0/61 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	3.4% 1/29 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	0.00% 0/59 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	3.3% 1/30 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.
Gastrointestinal disorders Diarrhoea	0.00% 0/61 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	1.6% 1/61 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	3.4% 1/29 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	0.00% 0/59 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	0.00% 0/30 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.
Investigations White blood cell count increased	1.6% 1/61 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	0.00% 0/61 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	0.00% 0/29 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	3.4% 2/59 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	0.00% 0/30 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.
Investigations Blood magnesium decreased	0.00% 0/61 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	1.6% 1/61 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	0.00% 0/29 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	3.4% 2/59 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	6.7% 2/30 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.
Investigations Gamma-glutamyltransferase increased	3.3% 2/61 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	0.00% 0/61 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	0.00% 0/29 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	1.7% 1/59 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	6.7% 2/30 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.
Investigations Leukocytes urine positive	0.00% 0/61 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	0.00% 0/61 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	3.4% 1/29 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	1.7% 1/59 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	0.00% 0/30 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.
Investigations Blood glucose decreased	0.00% 0/61 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	0.00% 0/61 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	3.4% 1/29 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	0.00% 0/59 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.	0.00% 0/30 • From enrollment until end of follow-up, up to 105 (±7) days post dosing The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.

Additional Information

Wenxi Xiang

Zhuhai Trinomab Pharmaceutical Co., Ltd.

Phone: 18083065921

Email: xiangwenxi@trinomab.com

Results disclosure agreements

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