Trial Outcomes & Findings for A Phase 1 Study to Evaluate PK Profile of Multiple Oral Administrations of TNP-2092 Capsules in Healthy Subjects (NCT NCT06190340)

NCT ID: NCT06190340

Last Updated: 2025-02-27

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 40 participants
• Primary outcome timeframe: Day 15: Before administration (within 60 minutes), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after administration
• Results posted on: 2025-02-27

Participant Flow

Participant milestones

Measure	TNP-2092 Capsules 100 mg 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 300 mg 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 600 mg 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.
Overall Study STARTED	12	12	8	8
Overall Study COMPLETED	12	12	8	8
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Phase 1 Study to Evaluate PK Profile of Multiple Oral Administrations of TNP-2092 Capsules in Healthy Subjects

Baseline characteristics by cohort

Measure	TNP-2092 Capsules 100 mg n=12 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 300 mg n=12 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 600 mg 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=8 Participants Subjects received Placebo 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.	Total n=40 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	12 Participants n=5 Participants	12 Participants n=7 Participants	8 Participants n=5 Participants	8 Participants n=4 Participants	40 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	29.4 years STANDARD_DEVIATION 7.99 • n=5 Participants	32.7 years STANDARD_DEVIATION 7.75 • n=7 Participants	33.5 years STANDARD_DEVIATION 5.78 • n=5 Participants	34.0 years STANDARD_DEVIATION 6.70 • n=4 Participants	32.1 years STANDARD_DEVIATION 7.24 • n=21 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	13 Participants n=21 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	8 Participants n=7 Participants	4 Participants n=5 Participants	6 Participants n=4 Participants	27 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	12 Participants n=5 Participants	12 Participants n=7 Participants	8 Participants n=5 Participants	8 Participants n=4 Participants	40 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
Positive rates of carbon 14 urea breath test (14C UBT)	12 Participants n=5 Participants	12 Participants n=7 Participants	8 Participants n=5 Participants	8 Participants n=4 Participants	40 Participants n=21 Participants

PRIMARY outcome

Timeframe: Day 1 to Day 49

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

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 100 mg n=12 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 300 mg n=12 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 600 mg 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=8 Participants Subjects received Placebo 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 Adverse Events (AEs)	6 participants	9 participants	4 participants	3 participants

PRIMARY outcome

Timeframe: Day 1：Before administration (within 60 minutes), 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after administration

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 Pharmacokinetics (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 100 mg n=12 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 300 mg n=12 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 600 mg 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 Placebo 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 Versus Time Curve Over a Dosing Interval (AUC0-tau) on Day 1	62.8 h*µg/L Standard Deviation 34.4	190 h*µg/L Standard Deviation 86.5	618 h*µg/L Standard Deviation 310	—

PRIMARY outcome

Timeframe: Day 1：Before administration (within 60 minutes), 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after administration

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 Pharmacokinetics (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 100 mg n=12 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 300 mg n=12 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 600 mg 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 Placebo 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 on Day 1	17.7 µg/L Standard Deviation 8.38	46.4 µg/L Standard Deviation 21.7	149 µg/L Standard Deviation 78.4	—

PRIMARY outcome

Timeframe: Day 1：Before administration (within 60 minutes), 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after administration

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 Pharmacokinetics (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 100 mg n=12 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 300 mg n=12 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 600 mg 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 Placebo 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 h Standard Deviation 1	4 h Standard Deviation 1	4 h Standard Deviation 0.8	—

PRIMARY outcome

Timeframe: Day 15: Before administration (within 60 minutes), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after administration

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 Pharmacokinetics (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 100 mg n=12 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 300 mg n=12 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 600 mg 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 Placebo 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 Versus Time Curve Extrapolated to Infinity (AUC0-inf) on Day 15	96.5 h*µg/L Standard Deviation 46.5	274 h*µg/L Standard Deviation 114	701 h*µg/L Standard Deviation 274	—

PRIMARY outcome

Timeframe: Day 15: Before administration (within 60 minutes), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after administration

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 Pharmacokinetics (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 100 mg n=12 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 300 mg n=12 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 600 mg 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 Placebo 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 Versus Time Curve From the First Administration to the Last Measurable Plasma Concentration (AUC0-last) on Day 15	93.3 h*µg/L Standard Deviation 46.1	267 h*µg/L Standard Deviation 112	692 h*µg/L Standard Deviation 272	—

PRIMARY outcome

Timeframe: Day 15: Before administration (within 60 minutes), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after administration

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 100 mg n=12 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 300 mg n=12 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 600 mg 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 Placebo 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 Versus Time Curve Over a Dosing Interval (AUC0-tau) on Day 15	90.7 h*µg/L Standard Deviation 41.1	250 h*µg/L Standard Deviation 105	657 h*µg/L Standard Deviation 257	—

PRIMARY outcome

Timeframe: Day 15: Before administration (within 60 minutes), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after administration

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 Pharmacokinetics (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 100 mg n=12 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 300 mg n=12 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 600 mg 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 Placebo 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 on Day 15	21.7 µg/L Standard Deviation 9.35	59.9 µg/L Standard Deviation 30.2	167 µg/L Standard Deviation 75.6	—

PRIMARY outcome

Timeframe: Day 15: Before administration (within 60 minutes), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after administration

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 Pharmacokinetics (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 100 mg n=12 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 300 mg n=12 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 600 mg 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 Placebo 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 h Standard Deviation 0.9	3 h Standard Deviation 2	4 h Standard Deviation 0.5	—

PRIMARY outcome

Timeframe: Day 15: Before administration (within 60 minutes), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after administration

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 Pharmacokinetics (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 100 mg n=12 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 300 mg n=12 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 600 mg 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 Placebo 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 on Day 15	3.26 h Standard Deviation 1.29	7.3 h Standard Deviation 4.91	6.67 h Standard Deviation 2.57	—

PRIMARY outcome

Timeframe: Four to 6 weeks after the last dose of the study drugs.

Population: All the subjects who were randomized into groups

Participants received 14 urea breath test [14C UBT] at 4 to 6 weeks after last dose.

Outcome measures

Measure	TNP-2092 Capsules 100 mg n=12 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 300 mg n=12 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 600 mg 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=8 Participants Subjects received Placebo 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.
Number of Participants With Negative Results of 14 Urea Breath Test (14C UBT) at 4 to 6 Weeks After Last Dose	1 participants	1 participants	0 participants	1 participants

PRIMARY outcome

Timeframe: Day 1：Before administration (within 60 minutes), 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after administration. Day 15: Before administration (within 60 minutes), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after administration

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 Pharmacokinetics (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) is calculated from the ratio of AUC0-tau (Day 15) to AUC0-tau(Day 1).

Outcome measures

Measure	TNP-2092 Capsules 100 mg n=12 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 300 mg n=12 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 600 mg 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 Placebo 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	1.65 ratio Standard Deviation 0.54	1.51 ratio Standard Deviation 0.99	1.19 ratio Standard Deviation 0.61	—

PRIMARY outcome

Timeframe: Day 1：Before administration (within 60 minutes), 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after administration. Day 15: Before administration (within 60 minutes), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after administration

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 Pharmacokinetics (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) is calculated from the ratio of Cmax (Day 15) to Cmax (Day 1).

Outcome measures

Measure	TNP-2092 Capsules 100 mg n=12 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 300 mg n=12 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 600 mg 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 Placebo 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	1.36 ratio Standard Deviation 0.46	1.61 ratio Standard Deviation 1.56	1.24 ratio Standard Deviation 0.66	—

Adverse Events

TNP-2092 Capsules 100 mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

TNP-2092 Capsules 300 mg

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

TNP-2092 Capsules 600 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	TNP-2092 Capsules 100 mg n=12 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 300 mg n=12 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 600 mg 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=8 participants at risk Subjects received Placebo 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 Alanine aminotransferase increased	25.0% 3/12 • Number of events 5 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	25.0% 3/12 • Number of events 6 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	37.5% 3/8 • Number of events 3 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	0.00% 0/8 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.
Investigations Aspartate aminotransferase increased	25.0% 3/12 • Number of events 3 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	16.7% 2/12 • Number of events 4 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	25.0% 2/8 • Number of events 2 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	0.00% 0/8 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.
Infections and infestations Urinary tract infection	8.3% 1/12 • Number of events 2 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	16.7% 2/12 • Number of events 2 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	12.5% 1/8 • Number of events 1 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	0.00% 0/8 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.
Skin and subcutaneous tissue disorders Rash	0.00% 0/12 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	16.7% 2/12 • Number of events 2 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	0.00% 0/8 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	0.00% 0/8 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.
Infections and infestations Upper respiratory tract infection	0.00% 0/12 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	8.3% 1/12 • Number of events 1 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	0.00% 0/8 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	12.5% 1/8 • Number of events 1 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.
Investigations Occult blood	0.00% 0/12 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	8.3% 1/12 • Number of events 1 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	0.00% 0/8 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	0.00% 0/8 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.
Investigations White blood cell count increased	8.3% 1/12 • Number of events 1 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	0.00% 0/12 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	0.00% 0/8 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	12.5% 1/8 • Number of events 1 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/12 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	8.3% 1/12 • Number of events 1 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	0.00% 0/8 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	0.00% 0/8 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.
Investigations White blood cells urine positive	0.00% 0/12 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	0.00% 0/12 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	12.5% 1/8 • Number of events 1 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	0.00% 0/8 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.
Investigations Blood albumin decreased	0.00% 0/12 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	0.00% 0/12 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	0.00% 0/8 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	12.5% 1/8 • Number of events 1 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.
Investigations Blood potassium increased	0.00% 0/12 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	8.3% 1/12 • Number of events 1 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	0.00% 0/8 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	0.00% 0/8 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.
General disorders Pyrexia	0.00% 0/12 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	8.3% 1/12 • Number of events 1 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	0.00% 0/8 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	0.00% 0/8 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.
Nervous system disorders Headache	0.00% 0/12 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	0.00% 0/12 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	0.00% 0/8 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	12.5% 1/8 • Number of events 1 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/12 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	0.00% 0/12 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	0.00% 0/8 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	12.5% 1/8 • Number of events 1 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.
Cardiac disorders Supraventricular extrasystoles	0.00% 0/12 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	8.3% 1/12 • Number of events 1 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	0.00% 0/8 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	0.00% 0/8 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.
Cardiac disorders Ventricular extrasystoles	0.00% 0/12 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	8.3% 1/12 • Number of events 1 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	0.00% 0/8 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	0.00% 0/8 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.
Infections and infestations Nasopharyngitis	0.00% 0/12 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	8.3% 1/12 • Number of events 1 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	0.00% 0/8 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	12.5% 1/8 • Number of events 1 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.
Renal and urinary disorders Proteinuria	8.3% 1/12 • Number of events 1 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	0.00% 0/12 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	0.00% 0/8 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	0.00% 0/8 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/12 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	8.3% 1/12 • Number of events 1 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	0.00% 0/8 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	0.00% 0/8 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.
Blood and lymphatic system disorders Anaemia	0.00% 0/12 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	8.3% 1/12 • Number of events 1 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	0.00% 0/8 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.	0.00% 0/8 • Day 1 to Day 49 An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as Adverse Events.

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