Trial Outcomes & Findings for PK Profile and Preliminary Efficacy of TNP-2092 Capsules in Liver Cirrhosis Patients With Hyperammonemia (NCT NCT06135675)

NCT ID: NCT06135675

Last Updated: 2025-04-25

Results Overview

To investigate the safety and tolerability of TNP-2092 by assessment of the number of participants with AEs following administration of TNP-2092 capsules. An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 36 participants
• Primary outcome timeframe: Up to 17 days after the first dosing.
• Results posted on: 2025-04-25

Participant Flow

Participant milestones

Measure	TNP-2092 Capsules 100mg Twice Daily(BID) TNP-2092 capsules: TNP-2092 capsules will be orally administered 30 min after breakfast and dinner for 14 consecutive days, and last dose will be administered 30 min after breakfast on the morning of D15.	TNP-2092 Capsules 300mg BID TNP-2092 capsules: TNP-2092 capsules will be orally administered 30 min after breakfast and dinner for 14 consecutive days, and last dose will be administered 30 min after breakfast on the morning of D15.	TNP-2092 Capsules 600mg BID TNP-2092 capsules: TNP-2092 capsules will be orally administered 30 min after breakfast and dinner for 14 consecutive days, and last dose will be administered 30 min after breakfast on the morning of D15.	TNP-2092 Capsules Placebo TNP-2092 capsules Placebo: TNP-2092 capsules Placebo will be orally administered 30 min after breakfast and dinner for 14 consecutive days, and last dose will be administered 30 min after breakfast on the morning of D15.
Overall Study STARTED	8	8	8	12
Overall Study COMPLETED	7	8	8	11
Overall Study NOT COMPLETED	1	0	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PK Profile and Preliminary Efficacy of TNP-2092 Capsules in Liver Cirrhosis Patients With Hyperammonemia

Baseline characteristics by cohort

Measure	TNP-2092 Capsules 100mg Twice Daily(BID) n=8 Participants TNP-2092 capsules: TNP-2092 capsules will be orally administered 30 min after breakfast and dinner for 14 consecutive days, and last dose will be administered 30 min after breakfast on the morning of D15.	TNP-2092 Capsules 300mg BID n=8 Participants TNP-2092 capsules: TNP-2092 capsules will be orally administered 30 min after breakfast and dinner for 14 consecutive days, and last dose will be administered 30 min after breakfast on the morning of D15.	TNP-2092 Capsules 600mg BID n=8 Participants TNP-2092 capsules: TNP-2092 capsules will be orally administered 30 min after breakfast and dinner for 14 consecutive days, and last dose will be administered 30 min after breakfast on the morning of D15.	TNP-2092 Capsules Placebo n=12 Participants TNP-2092 capsules Placebo: TNP-2092 capsules Placebo will be orally administered 30 min after breakfast and dinner for 14 consecutive days, and last dose will be administered 30 min after breakfast on the morning of D15.	Total n=36 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	12 Participants n=4 Participants	36 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Continuous	49.5 years STANDARD_DEVIATION 7.19 • n=5 Participants	50.4 years STANDARD_DEVIATION 5.71 • n=7 Participants	51.9 years STANDARD_DEVIATION 7.97 • n=5 Participants	52.3 years STANDARD_DEVIATION 10.15 • n=4 Participants	51.1 years STANDARD_DEVIATION 8.0 • n=21 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	8 Participants n=21 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	7 Participants n=7 Participants	5 Participants n=5 Participants	8 Participants n=4 Participants	28 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	8 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	12 Participants n=4 Participants	36 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) 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
Race (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
Fasting Venous Blood Ammonia Concentration	90.1 μmol/L STANDARD_DEVIATION 27.1 • n=5 Participants	80.3 μmol/L STANDARD_DEVIATION 19.5 • n=7 Participants	78.8 μmol/L STANDARD_DEVIATION 17.3 • n=5 Participants	115.8 μmol/L STANDARD_DEVIATION 39.1 • n=4 Participants	94.0 μmol/L STANDARD_DEVIATION 32.0 • n=21 Participants

PRIMARY outcome

Timeframe: Up to 17 days after the first dosing.

Population: All subjects who have received at least one dose of study drug.

To investigate the safety and tolerability of TNP-2092 by assessment of the number of participants with AEs following administration of TNP-2092 capsules. An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.

Outcome measures

Measure	TNP-2092 Capsules 100mg Twice Daily(BID) n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 100 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	TNP-2092 Capsules 300mg BID n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 300 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	TNP-2092 Capsules 600mg BID n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 600 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	Placebo n=12 Participants Subjects received TNP-2092 placebo capsules orally twice daily in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.
Safety of TNP-2092 by Assessment of the Number of Participants With Adverse Events (AEs)	6 participants	6 participants	7 participants	8 participants

PRIMARY outcome

Timeframe: Day 1: 30-60 min prior to the first dose, and 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h and 12 h post-dose

Population: All subjects who have been randomized into groups, have received at least one dose of study drug, and have at least one evaluable pharmacokinetic parameter.

Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma PK parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.

Outcome measures

Measure	TNP-2092 Capsules 100mg Twice Daily(BID) n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 100 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	TNP-2092 Capsules 300mg BID n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 300 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	TNP-2092 Capsules 600mg BID n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 600 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	Placebo Subjects received TNP-2092 placebo capsules orally twice daily in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.
Maximum Observed Plasma Concentration (Cmax) of TNP-2092 Capsules in Liver Cirrhosis Patients With Hyperammonemia on Day 1.	90.4 ng/ml Standard Deviation 42.9	140 ng/ml Standard Deviation 120	415 ng/ml Standard Deviation 294	—

PRIMARY outcome

Timeframe: Day 1: 30-60 min prior to the first dose, and 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h and 12 h post-dose

Population: All subjects who have been randomized into groups, have received at least one dose of study drug, and have at least one evaluable pharmacokinetic parameter.

Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma PK parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.

Outcome measures

Measure	TNP-2092 Capsules 100mg Twice Daily(BID) n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 100 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	TNP-2092 Capsules 300mg BID n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 300 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	TNP-2092 Capsules 600mg BID n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 600 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	Placebo Subjects received TNP-2092 placebo capsules orally twice daily in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.
Area Under the Plasma Concentration-time Curve From the Time of Administration to the Time of the Last Measurable Plasma Concentration (AUC0-last) on Day 1.	309 h*ng/ml Standard Deviation 178	524 h*ng/ml Standard Deviation 537	1610 h*ng/ml Standard Deviation 1200	—

PRIMARY outcome

Timeframe: Day 15: 30-60 min prior to the first dose, and 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 24 h and 36 h post-dose

Population: All subjects who have been randomized into groups, have received at least one dose of study drug, and have at least one evaluable pharmacokinetic parameter.

Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma PK parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.

Outcome measures

Measure	TNP-2092 Capsules 100mg Twice Daily(BID) n=7 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 100 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	TNP-2092 Capsules 300mg BID n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 300 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	TNP-2092 Capsules 600mg BID n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 600 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	Placebo Subjects received TNP-2092 placebo capsules orally twice daily in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.
Area Under the Plasma Concentration-time Curve From the Time of Administration Extrapolated to Infinity (AUC0-∞) on Day 15	396 h*ng/ml Standard Deviation 257	756 h*ng/ml Standard Deviation 570	2680 h*ng/ml Standard Deviation 1790	—

PRIMARY outcome

Timeframe: Day 1: 30-60 min prior to the first dose, and 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h and 12 h post-dose

Population: All subjects who have been randomized into groups, have received at least one dose of study drug, and have at least one evaluable pharmacokinetic parameter.

Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma PK parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.

Outcome measures

Measure	TNP-2092 Capsules 100mg Twice Daily(BID) n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 100 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	TNP-2092 Capsules 300mg BID n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 300 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	TNP-2092 Capsules 600mg BID n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 600 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	Placebo Subjects received TNP-2092 placebo capsules orally twice daily in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.
Time to Reach the Maximum Observed Plasma Concentration (Tmax) on Day 1	4.75 h Standard Deviation 0.46	5.13 h Standard Deviation 0.36	5.13 h Standard Deviation 0.35	—

PRIMARY outcome

Timeframe: Day 15: 30-60 min prior to the first dose, and 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 24 h and 36 h post-dose

Population: All subjects who have been randomized into groups, have received at least one dose of study drug, and have at least one evaluable pharmacokinetic parameter.

Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma PK parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.

Outcome measures

Measure	TNP-2092 Capsules 100mg Twice Daily(BID) n=7 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 100 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	TNP-2092 Capsules 300mg BID n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 300 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	TNP-2092 Capsules 600mg BID n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 600 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	Placebo Subjects received TNP-2092 placebo capsules orally twice daily in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.
Maximum Observed Plasma Concentration (Cmax) of TNP-2092 Capsules in Liver Cirrhosis Patients With Hyperammonemia on Day 15.	60.8 ng/ml Standard Deviation 28.5	164 ng/ml Standard Deviation 118	543 ng/ml Standard Deviation 420	—

PRIMARY outcome

Timeframe: Day 15: 30-60 min prior to the first dose, and 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 24 h and 36 h post-dose

Population: All subjects who have been randomized into groups, have received at least one dose of study drug, and have at least one evaluable pharmacokinetic parameter.

Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma PK parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.

Outcome measures

Measure	TNP-2092 Capsules 100mg Twice Daily(BID) n=7 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 100 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	TNP-2092 Capsules 300mg BID n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 300 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	TNP-2092 Capsules 600mg BID n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 600 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	Placebo Subjects received TNP-2092 placebo capsules orally twice daily in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.
Area Under the Plasma Concentration-time Curve From the Time of Administration to the Time of the Last Measurable Plasma Concentration (AUC0-last) on Day 15.	380 h*ng/ml Standard Deviation 247	739 h*ng/ml Standard Deviation 555	2610 h*ng/ml Standard Deviation 1730	—

PRIMARY outcome

Timeframe: Day 15: 30-60 min prior to the first dose, and 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 24 h and 36 h post-dose

Population: All subjects who have been randomized into groups, have received at least one dose of study drug, and have at least one evaluable pharmacokinetic parameter.

Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma PK parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.

Outcome measures

Measure	TNP-2092 Capsules 100mg Twice Daily(BID) n=7 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 100 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	TNP-2092 Capsules 300mg BID n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 300 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	TNP-2092 Capsules 600mg BID n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 600 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	Placebo Subjects received TNP-2092 placebo capsules orally twice daily in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.
Time to Reach the Maximum Observed Plasma Concentration (Tmax) Day 15	4.43 h Standard Deviation 0.78	4.75 h Standard Deviation 0.46	4.50 h Standard Deviation 1.85	—

PRIMARY outcome

Timeframe: Day 1: 30-60 min prior to the first dose, and 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h and 12 h post-dose

Population: All subjects who have been randomized into groups, have received at least one dose of study drug, and have at least one evaluable pharmacokinetic parameter.

Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma PK parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.

Outcome measures

Measure	TNP-2092 Capsules 100mg Twice Daily(BID) n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 100 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	TNP-2092 Capsules 300mg BID n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 300 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	TNP-2092 Capsules 600mg BID n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 600 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	Placebo Subjects received TNP-2092 placebo capsules orally twice daily in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.
Area Under the Plasma Concentration-time Curve From the Time of Administration Extrapolated to Infinity (AUC0-∞) Day 1	332 h*ng/ml Standard Deviation 188	561 h*ng/ml Standard Deviation 565	1790 h*ng/ml Standard Deviation 1210	—

PRIMARY outcome

Timeframe: Day 1: 30-60 min prior to the first dose, and 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h and 12 h post-dose

Population: All subjects who have been randomized into groups, have received at least one dose of study drug, and have at least one evaluable pharmacokinetic parameter.

Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma PK parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.

Outcome measures

Measure	TNP-2092 Capsules 100mg Twice Daily(BID) n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 100 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	TNP-2092 Capsules 300mg BID n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 300 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	TNP-2092 Capsules 600mg BID n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 600 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	Placebo Subjects received TNP-2092 placebo capsules orally twice daily in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.
Half Life (t1/2) of TNP-2092 Capsules on Day 1	2.52 h Standard Deviation 0.63	2.23 h Standard Deviation 0.81	2.99 h Standard Deviation 2.29	—

PRIMARY outcome

Timeframe: Day 15: 30-60 min prior to the first dose, and 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 24 h and 36 h post-dose

Population: All subjects who have been randomized into groups, have received at least one dose of study drug, and have at least one evaluable pharmacokinetic parameter.

Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma PK parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.

Outcome measures

Measure	TNP-2092 Capsules 100mg Twice Daily(BID) n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 100 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	TNP-2092 Capsules 300mg BID n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 300 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	TNP-2092 Capsules 600mg BID n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 600 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	Placebo Subjects received TNP-2092 placebo capsules orally twice daily in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.
Half Life (t1/2) of TNP-2092 Capsules on Day 15	8.17 h Standard Deviation 1.84	6.92 h Standard Deviation 2.63	7.93 h Standard Deviation 1.09	—

PRIMARY outcome

Timeframe: Day 1: 30-60 min prior to the first dose, and 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h and 12 h post-dose

Population: All subjects who have been randomized into groups, have received at least one dose of study drug, and have at least one evaluable pharmacokinetic parameter.

Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma PK parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.

Outcome measures

Measure	TNP-2092 Capsules 100mg Twice Daily(BID) n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 100 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	TNP-2092 Capsules 300mg BID n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 300 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	TNP-2092 Capsules 600mg BID n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 600 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	Placebo Subjects received TNP-2092 placebo capsules orally twice daily in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.
Area Under the Plasma Concentration-time Curve Within a Dosing Interval (AUC0-tau) on Day 1	309 h*ng/mL Standard Deviation 179	525 h*ng/mL Standard Deviation 538	1610 h*ng/mL Standard Deviation 1200	—

PRIMARY outcome

Timeframe: Day 15: 30-60 min prior to the first dose, and 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 24 h and 36 h post-dose

Population: All subjects who have been randomized into groups, have received at least one dose of study drug, and have at least one evaluable pharmacokinetic parameter.

Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma PK parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.

Outcome measures

Measure	TNP-2092 Capsules 100mg Twice Daily(BID) n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 100 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	TNP-2092 Capsules 300mg BID n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 300 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	TNP-2092 Capsules 600mg BID n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 600 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	Placebo Subjects received TNP-2092 placebo capsules orally twice daily in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.
Area Under the Plasma Concentration-time Curve Within a Dosing Interval (AUC0-tau) on Day 15	303 h*ng/mL Standard Deviation 187	646 h*ng/mL Standard Deviation 466	2230 h*ng/mL Standard Deviation 1480	—

PRIMARY outcome

Timeframe: Day 1: 30-60 min prior to first dose, and 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, and 12 h post-dose (prior to next dose). Day 15: 30-60 min pre-dose, and 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 24 h and 36 h post-dose.

Population: All subjects who have been randomized into groups, have received at least one dose of study drug, and have at least one evaluable pharmacokinetic parameter.

Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma PK parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.

Rac (Cmax) was calculated from the ratio of Cmax (Day 15) to Cmax (Day 1)

Outcome measures

Measure	TNP-2092 Capsules 100mg Twice Daily(BID) n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 100 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	TNP-2092 Capsules 300mg BID n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 300 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	TNP-2092 Capsules 600mg BID n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 600 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	Placebo Subjects received TNP-2092 placebo capsules orally twice daily in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.
Accumulation Index Rac(Cmax) of TNP-2092 Capsules in Liver Cirrhosis Patients With Hyperammonemia	0.74 ratio Standard Deviation 0.22	1.23 ratio Standard Deviation 0.49	1.26 ratio Standard Deviation 0.42	—

PRIMARY outcome

Timeframe: Day 1: 30-60 min prior to first dose, and 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, and 12 h post-dose (prior to next dose). Day 15: 30-60 min pre-dose, and 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 24 h and 36 h post-dose.

Population: All subjects who have been randomized into groups, have received at least one dose of study drug, and have at least one evaluable pharmacokinetic parameter.

Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma PK parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.

Rac (AUC) was calculated from the ratio of AUC0-tau (Day 15) to AUC0-tau(Day 1).

Outcome measures

Measure	TNP-2092 Capsules 100mg Twice Daily(BID) n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 100 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	TNP-2092 Capsules 300mg BID n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 300 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	TNP-2092 Capsules 600mg BID n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 600 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	Placebo Subjects received TNP-2092 placebo capsules orally twice daily in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.
Accumulation Index Rac(AUC) of TNP-2092 Capsules in Liver Cirrhosis Patients With Hyperammonemia	1.09 ratio Standard Deviation 0.40	1.38 ratio Standard Deviation 0.39	1.47 ratio Standard Deviation 0.55	—

SECONDARY outcome

Timeframe: Baseline and Day 15

Population: All the subjects who were randomized into groups

The changes in the fasting venous blood ammonia concentration from baseline will be compared with the placebo to evaluate the preliminary efficacy of TNP-2092 Capsules in liver cirrhosis patients with hyperammonemia.

Outcome measures

Measure	TNP-2092 Capsules 100mg Twice Daily(BID) n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 100 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	TNP-2092 Capsules 300mg BID n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 300 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	TNP-2092 Capsules 600mg BID n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 600 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	Placebo n=12 Participants Subjects received TNP-2092 placebo capsules orally twice daily in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.
Changes in the Fasting Venous Blood Ammonia Concentration From Baseline (Mean Pre-treatment Measured)	5.7 μmol/L Standard Deviation 17.50	-2.1 μmol/L Standard Deviation 22.49	-14.1 μmol/L Standard Deviation 18.12	0.5 μmol/L Standard Deviation 45.29

SECONDARY outcome

Timeframe: Baseline, Day 7 and Day 15

Population: All the subjects who were randomized into groups

Evaluation of NCT-A is based on the time required to complete the test. The results will be positive according to following criteria: 1) the time is over 34.3 seconds while the age is less than 35 years; 2) the time is over 45.7 seconds while the age is between 35 to 44 years; 3) the time is over 52.8 seconds while age is between 45 to 54 years; 4) the time is over 61.9 seconds while the age is between 55 to 64 years.

The positive result means a worse outcome.

Outcome measures

Measure	TNP-2092 Capsules 100mg Twice Daily(BID) n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 100 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	TNP-2092 Capsules 300mg BID n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 300 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	TNP-2092 Capsules 600mg BID n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 600 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	Placebo n=12 Participants Subjects received TNP-2092 placebo capsules orally twice daily in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.
Proportion of Participants With Positive Result of Number Connection Test A (NCT-A) Baseline	6 Participants	6 Participants	8 Participants	12 Participants
Proportion of Participants With Positive Result of Number Connection Test A (NCT-A) Day 7	7 Participants	6 Participants	8 Participants	12 Participants
Proportion of Participants With Positive Result of Number Connection Test A (NCT-A) Day 15	5 Participants	7 Participants	8 Participants	11 Participants

SECONDARY outcome

Timeframe: Baseline, Day 7 and Day 15

Population: All the subjects who were randomized into groups

Evaluation of Digital symbol test (DST) is based on the score gained within 90 seconds, and the results are positive according to following criteria: 1) the score is less than 40.5 while the age is less than 35 years; 2) the score is less than 35.0 while the age is between 35 to 44 years; 3) the score is less than 28.5 while the age is between 45 to 54 years; 4) the score is less than 26.0 while the age is between 55 to 64 years.

The positive result means a worse outcome.

Outcome measures

Measure	TNP-2092 Capsules 100mg Twice Daily(BID) n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 100 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	TNP-2092 Capsules 300mg BID n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 300 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	TNP-2092 Capsules 600mg BID n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 600 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	Placebo n=12 Participants Subjects received TNP-2092 placebo capsules orally twice daily in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.
Proportion of Participants With Positive Result of Digital Symbol Test (DST) Baseline	4 Participants	2 Participants	3 Participants	7 Participants
Proportion of Participants With Positive Result of Digital Symbol Test (DST) Day 7	4 Participants	2 Participants	3 Participants	8 Participants
Proportion of Participants With Positive Result of Digital Symbol Test (DST) Day 15	0 Participants	1 Participants	3 Participants	7 Participants

SECONDARY outcome

Timeframe: Baseline, Day 7 and Day 15

Population: All the subjects who were randomized into groups

Changes in the total scores of QOL from baseline will be compared with the placebo to evaluate the preliminary efficacy of TNP-2092 Capsules in liver cirrhosis patients with hyperammonemia. The range of QOL scores is 30 ~ 150. Patients with lower scores means a better outcome.

Outcome measures

Measure	TNP-2092 Capsules 100mg Twice Daily(BID) n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 100 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	TNP-2092 Capsules 300mg BID n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 300 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	TNP-2092 Capsules 600mg BID n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 600 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	Placebo n=12 Participants Subjects received TNP-2092 placebo capsules orally twice daily in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.
Changes in the Total Scores of Quality of Life (QOL) From Baseline Day 7	-6.1 score on a scale Standard Deviation 5.64	6.4 score on a scale Standard Deviation 15.80	3.1 score on a scale Standard Deviation 13.91	0.5 score on a scale Standard Deviation 9.21
Changes in the Total Scores of Quality of Life (QOL) From Baseline Day 15	-3.0 score on a scale Standard Deviation 4.73	7.1 score on a scale Standard Deviation 15.82	4.6 score on a scale Standard Deviation 5.63	-1.4 score on a scale Standard Deviation 15.88

SECONDARY outcome

Timeframe: Baseline, Day 7 and Day 15

Population: All the subjects who were randomized into groups

Asterixis is a physical exam finding that can be elicited by asking the participant to extend the arms, flex the wrists, and spread the fingers wide. Clinically, asterixis produces flapping tremors. In a flapping tremor, an participant will flap their wrists like a bird flapping its wings.

Asterixis elicited means a worse outcome.

Outcome measures

Measure	TNP-2092 Capsules 100mg Twice Daily(BID) n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 100 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	TNP-2092 Capsules 300mg BID n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 300 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	TNP-2092 Capsules 600mg BID n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 600 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	Placebo n=12 Participants Subjects received TNP-2092 placebo capsules orally twice daily in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.
Proportion of Participants Whose Asterixis is Elicited Whether asterixis is elicited at Baseline · Yes	0 Participants	0 Participants	0 Participants	0 Participants
Proportion of Participants Whose Asterixis is Elicited Whether asterixis is elicited at Baseline · No	8 Participants	8 Participants	8 Participants	12 Participants
Proportion of Participants Whose Asterixis is Elicited Whether asterixis is elicited on Day 7 · Yes	0 Participants	0 Participants	0 Participants	0 Participants
Proportion of Participants Whose Asterixis is Elicited Whether asterixis is elicited on Day 7 · No	8 Participants	8 Participants	8 Participants	12 Participants
Proportion of Participants Whose Asterixis is Elicited Whether asterixis is elicited on Day 15 · Yes	0 Participants	0 Participants	0 Participants	0 Participants
Proportion of Participants Whose Asterixis is Elicited Whether asterixis is elicited on Day 15 · No	8 Participants	8 Participants	8 Participants	12 Participants

SECONDARY outcome

Timeframe: Baseline, Day 7 and Day 15

Population: All the subjects who were randomized into groups

Grade 0 of HE (without HE) is nomal, Grade 0 of HE (MHE) is alterations of brain function in neuropsychological or neurophysiological measures without clinical signs of HE, Grade 1 of HE is mild lack of awareness, Grade 2 of HE is lethargic, Grade 3 of HE is somnolent, and Grade 4 of HE is coma.

Higher score means worse outcome.

Outcome measures

Measure	TNP-2092 Capsules 100mg Twice Daily(BID) n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 100 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	TNP-2092 Capsules 300mg BID n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 300 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	TNP-2092 Capsules 600mg BID n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 600 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	Placebo n=12 Participants Subjects received TNP-2092 placebo capsules orally twice daily in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.
Clinical Grade of Hepatic Encephalopathy Baseline · Grade 0 of HE (without HE)	2 Participants	2 Participants	0 Participants	0 Participants
Clinical Grade of Hepatic Encephalopathy Baseline · Grade 0 of HE (MHE)	6 Participants	6 Participants	8 Participants	12 Participants
Clinical Grade of Hepatic Encephalopathy Baseline · Grade 1 of HE	0 Participants	0 Participants	0 Participants	0 Participants
Clinical Grade of Hepatic Encephalopathy Baseline · Grade 2 of HE	0 Participants	0 Participants	0 Participants	0 Participants
Clinical Grade of Hepatic Encephalopathy Baseline · Grade 3 of HE	0 Participants	0 Participants	0 Participants	0 Participants
Clinical Grade of Hepatic Encephalopathy Baseline · Grade 4 of HE	0 Participants	0 Participants	0 Participants	0 Participants
Clinical Grade of Hepatic Encephalopathy Day 7 · Grade 0 of HE (without HE)	1 Participants	1 Participants	0 Participants	0 Participants
Clinical Grade of Hepatic Encephalopathy Day 7 · Grade 0 of HE (MHE)	7 Participants	7 Participants	8 Participants	12 Participants
Clinical Grade of Hepatic Encephalopathy Day 7 · Grade 1 of HE	0 Participants	0 Participants	0 Participants	0 Participants
Clinical Grade of Hepatic Encephalopathy Day 7 · Grade 2 of HE	0 Participants	0 Participants	0 Participants	0 Participants
Clinical Grade of Hepatic Encephalopathy Day 7 · Grade 3 of HE	0 Participants	0 Participants	0 Participants	0 Participants
Clinical Grade of Hepatic Encephalopathy Day 7 · Grade 4 of HE	0 Participants	0 Participants	0 Participants	0 Participants
Clinical Grade of Hepatic Encephalopathy Day 15 · Grade 0 of HE (without HE)	1 Participants	1 Participants	0 Participants	0 Participants
Clinical Grade of Hepatic Encephalopathy Day 15 · Grade 0 of HE (MHE)	7 Participants	7 Participants	8 Participants	12 Participants
Clinical Grade of Hepatic Encephalopathy Day 15 · Grade 1 of HE	0 Participants	0 Participants	0 Participants	0 Participants
Clinical Grade of Hepatic Encephalopathy Day 15 · Grade 2 of HE	0 Participants	0 Participants	0 Participants	0 Participants
Clinical Grade of Hepatic Encephalopathy Day 15 · Grade 3 of HE	0 Participants	0 Participants	0 Participants	0 Participants
Clinical Grade of Hepatic Encephalopathy Day 15 · Grade 4 of HE	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline to Day 15

Population: All the subjects who were randomized into groups

Plasma concentrations of Blood Ammonia were measured by a specific and validated assay. Changes in the Fasting Venous Blood Ammonia Concentration From Baseline were used to measure AUC.

Outcome measures

Measure	TNP-2092 Capsules 100mg Twice Daily(BID) n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 100 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	TNP-2092 Capsules 300mg BID n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 300 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	TNP-2092 Capsules 600mg BID n=8 Participants Subjects received TNP-2092 capsules orally twice daily at the dose of 600 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	Placebo n=12 Participants Subjects received TNP-2092 placebo capsules orally twice daily in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.
Areas Under the Blood Ammonia Concentration-time Curve Day 1	481.6 h*μmol/L Standard Deviation 564.5	480.2 h*μmol/L Standard Deviation 607.9	225.0 h*μmol/L Standard Deviation 544.1	85.5 h*μmol/L Standard Deviation 999.3
Areas Under the Blood Ammonia Concentration-time Curve Day 1-Day 15	-1716.7 h*μmol/L Standard Deviation 5778.5	-3205.4 h*μmol/L Standard Deviation 8311.8	-5805.6 h*μmol/L Standard Deviation 6080.5	-5476.3 h*μmol/L Standard Deviation 12816.5

Adverse Events

TNP-2092 Capsules 100mg Twice Daily(BID)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

TNP-2092 Capsules 300mg BID

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

TNP-2092 Capsules 600mg BID

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	TNP-2092 Capsules 100mg Twice Daily(BID) n=8 participants at risk Subjects received TNP-2092 capsules orally twice daily at the dose of 100 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	TNP-2092 Capsules 300mg BID n=8 participants at risk Subjects received TNP-2092 capsules orally twice daily at the dose of 300 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	TNP-2092 Capsules 600mg BID n=8 participants at risk Subjects received TNP-2092 capsules orally twice daily at the dose of 600 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	Placebo n=12 participants at risk Subjects received TNP-2092 placebo capsules orally twice daily in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/8 • 17 days after the first dose	0.00% 0/8 • 17 days after the first dose	0.00% 0/8 • 17 days after the first dose	8.3% 1/12 • Number of events 1 • 17 days after the first dose

Other adverse events

Measure	TNP-2092 Capsules 100mg Twice Daily(BID) n=8 participants at risk Subjects received TNP-2092 capsules orally twice daily at the dose of 100 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	TNP-2092 Capsules 300mg BID n=8 participants at risk Subjects received TNP-2092 capsules orally twice daily at the dose of 300 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	TNP-2092 Capsules 600mg BID n=8 participants at risk Subjects received TNP-2092 capsules orally twice daily at the dose of 600 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.	Placebo n=12 participants at risk Subjects received TNP-2092 placebo capsules orally twice daily in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.
Investigations neutrophil count decreased	25.0% 2/8 • Number of events 4 • 17 days after the first dose	50.0% 4/8 • Number of events 6 • 17 days after the first dose	75.0% 6/8 • Number of events 7 • 17 days after the first dose	50.0% 6/12 • Number of events 7 • 17 days after the first dose
Investigations white blood cell count decreased	25.0% 2/8 • Number of events 2 • 17 days after the first dose	25.0% 2/8 • Number of events 3 • 17 days after the first dose	75.0% 6/8 • Number of events 7 • 17 days after the first dose	33.3% 4/12 • Number of events 4 • 17 days after the first dose
Investigations Lymphocyte count decreased	12.5% 1/8 • Number of events 1 • 17 days after the first dose	25.0% 2/8 • Number of events 4 • 17 days after the first dose	50.0% 4/8 • Number of events 5 • 17 days after the first dose	16.7% 2/12 • Number of events 4 • 17 days after the first dose
Metabolism and nutrition disorders Hypoalbuminaemia	25.0% 2/8 • Number of events 2 • 17 days after the first dose	25.0% 2/8 • Number of events 3 • 17 days after the first dose	12.5% 1/8 • Number of events 2 • 17 days after the first dose	16.7% 2/12 • Number of events 2 • 17 days after the first dose
Investigations Platelet count decreased	37.5% 3/8 • Number of events 4 • 17 days after the first dose	12.5% 1/8 • Number of events 5 • 17 days after the first dose	0.00% 0/8 • 17 days after the first dose	41.7% 5/12 • Number of events 5 • 17 days after the first dose
Investigations Lipase increased	37.5% 3/8 • Number of events 3 • 17 days after the first dose	0.00% 0/8 • 17 days after the first dose	0.00% 0/8 • 17 days after the first dose	0.00% 0/12 • 17 days after the first dose
Investigations Alanine aminotransferase increased	0.00% 0/8 • 17 days after the first dose	25.0% 2/8 • Number of events 2 • 17 days after the first dose	0.00% 0/8 • 17 days after the first dose	0.00% 0/12 • 17 days after the first dose
Investigations Aspartate aminotransferase increased	0.00% 0/8 • 17 days after the first dose	25.0% 2/8 • Number of events 2 • 17 days after the first dose	0.00% 0/8 • 17 days after the first dose	0.00% 0/12 • 17 days after the first dose
Investigations Blood bilirubin increased	0.00% 0/8 • 17 days after the first dose	12.5% 1/8 • Number of events 1 • 17 days after the first dose	12.5% 1/8 • Number of events 1 • 17 days after the first dose	0.00% 0/12 • 17 days after the first dose
Investigations Blood fibrinogen decreased	25.0% 2/8 • Number of events 2 • 17 days after the first dose	0.00% 0/8 • 17 days after the first dose	0.00% 0/8 • 17 days after the first dose	8.3% 1/12 • Number of events 1 • 17 days after the first dose
Gastrointestinal disorders Abdominal distention	12.5% 1/8 • Number of events 2 • 17 days after the first dose	0.00% 0/8 • 17 days after the first dose	12.5% 1/8 • Number of events 1 • 17 days after the first dose	8.3% 1/12 • Number of events 3 • 17 days after the first dose
Blood and lymphatic system disorders Anaemia	12.5% 1/8 • Number of events 1 • 17 days after the first dose	12.5% 1/8 • Number of events 1 • 17 days after the first dose	0.00% 0/8 • 17 days after the first dose	16.7% 2/12 • Number of events 2 • 17 days after the first dose

Additional Information

TenNor

TenNor Therapeutics (Suzhou) Limited.

Phone: 0512-86861990

Email: info@tennorx.com

Results disclosure agreements

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