Trial Outcomes & Findings for Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15912(Sonefpeglutide) in Healthy Korean Subjects (NCT NCT04076293)

NCT ID: NCT04076293

Last Updated: 2025-02-10

Results Overview

Number of participants with any treatment-emergent adverse events related to study medication.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 40 participants
• Primary outcome timeframe: after single subcutaneous (SC) doses for 44 days
• Results posted on: 2025-02-10

Participant Flow

Date of first enrollment was October 8th, 2019.

The planned maximum dose of HM15912 was 1.5 mg/kg; however, higher doses were allowed to be administered if safety was confirmed in previous cohorts. If dose was escalated to more than 1.5 mg/kg, Ministry of Food and Drug Safety (MFDS) approval was to be obtained.

Participant milestones

Measure	HM15912 0.05mg/kg HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).	HM15912 0.1mg/kg HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).	HM15912 0.5mg/kg HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).	HM15912 1.0mg/kg HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).	HM15912 1.5mg/kg HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).	Placebo Placebo: Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo). Total of 10 subjects for placebo.
Overall Study STARTED	6	6	6	6	6	10
Overall Study COMPLETED	6	6	6	6	6	10
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15912(Sonefpeglutide) in Healthy Korean Subjects

Baseline characteristics by cohort

Measure	HM15912 0.05mg/kg n=6 Participants HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).	HM15912 0.1mg/kg n=6 Participants HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).	HM15912 0.5mg/kg n=6 Participants HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).	HM15912 1.0 mg/kg n=6 Participants HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).	HM15912 1.5mg/kg n=6 Participants HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).	Placebo n=10 Participants Placebo: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).	Total n=40 Participants Total of all reporting groups
Age, Continuous	31 Years STANDARD_DEVIATION 5.18 • n=5 Participants	28.3 Years STANDARD_DEVIATION 8.87 • n=7 Participants	26.0 Years STANDARD_DEVIATION 5.83 • n=5 Participants	25.0 Years STANDARD_DEVIATION 3.52 • n=4 Participants	31.7 Years STANDARD_DEVIATION 7.39 • n=21 Participants	27.2 Years STANDARD_DEVIATION 2.39 • n=8 Participants	28.4 Years STANDARD_DEVIATION 6.54 • n=8 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	6 Participants n=21 Participants	10 Participants n=8 Participants	40 Participants n=8 Participants
Race/Ethnicity, Customized Korean	6 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	6 Participants n=21 Participants	10 Participants n=8 Participants	40 Participants n=8 Participants
Region of Enrollment South Korea	6 participants n=5 Participants	6 participants n=7 Participants	6 participants n=5 Participants	6 participants n=4 Participants	6 participants n=21 Participants	10 participants n=8 Participants	40 participants n=8 Participants

PRIMARY outcome

Timeframe: after single subcutaneous (SC) doses for 44 days

Population: Each analysis population was included in the analyses, based on the actually administered IMP and dosage.

Number of participants with any treatment-emergent adverse events related to study medication.

Outcome measures

Measure	HM15912 0.05mg/kg n=6 Participants HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).	HM15912 0.1mg/kg n=6 Participants HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).	HM15912 0.5mg/kg n=6 Participants HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).	HM15912 1.0mg/kg n=6 Participants HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).	HM15912 1.5mg/kg n=6 Participants HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).	Placebo n=10 Participants Placebo: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).
Number of Participants With Treatment-emergent Adverse Events of HM15912 Mild TEAE	3 Participants	1 Participants	2 Participants	4 Participants	4 Participants	5 Participants
Number of Participants With Treatment-emergent Adverse Events of HM15912 Moderate TEAE	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Treatment-emergent Adverse Events of HM15912 No AE	3 Participants	3 Participants	4 Participants	2 Participants	2 Participants	4 Participants

PRIMARY outcome

Timeframe: after single subcutaneous (SC) doses for 44 days

Outcome measures

Measure	HM15912 0.05mg/kg n=6 Participants HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).	HM15912 0.1mg/kg n=6 Participants HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).	HM15912 0.5mg/kg n=6 Participants HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).	HM15912 1.0mg/kg n=6 Participants HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).	HM15912 1.5mg/kg n=6 Participants HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).	Placebo n=10 Participants Placebo: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).
Number of Participants With Significant Findings Observed for Hematology	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: after single subcutaneous (SC) doses at day 1,2,3,4,5,6,7,10,17 and 30

To assess the Concentration Max profile of HM15912 after single SC doses.

Outcome measures

Measure	HM15912 0.05mg/kg n=6 Participants HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).	HM15912 0.1mg/kg n=6 Participants HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).	HM15912 0.5mg/kg n=6 Participants HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).	HM15912 1.0mg/kg n=6 Participants HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).	HM15912 1.5mg/kg n=6 Participants HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).	Placebo n=10 Participants Placebo: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).
Concentration Max Profile of HM15912	249.45 ng/mL Geometric Coefficient of Variation 51.77	622.46 ng/mL Geometric Coefficient of Variation 14.06	3550.79 ng/mL Geometric Coefficient of Variation 36.44	8347.70 ng/mL Geometric Coefficient of Variation 10.30	9393.06 ng/mL Geometric Coefficient of Variation 13.24	0 ng/mL Geometric Coefficient of Variation 0

Adverse Events

HM15912 0.05mg/kg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

HM15912 0.1mg/kg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

HM15912 0.5mg/kg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

HM15912 1.0mg/kg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

HM15912 1.5mg/kg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	HM15912 0.05mg/kg n=6 participants at risk HM15912 0.05mg/kg: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).	HM15912 0.1mg/kg n=6 participants at risk HM15912 0.1mg/kg: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).	HM15912 0.5mg/kg n=6 participants at risk HM15912 0.5mg/kg: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).	HM15912 1.0mg/kg n=6 participants at risk HM15912 1.0mg/kg: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).	HM15912 1.5mg/kg n=6 participants at risk HM15912 1.5mg/kg: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).	Placebo n=10 participants at risk Placebo: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).
General disorders Injection site bruising	0.00% 0/6 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.	0.00% 0/6 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.	0.00% 0/6 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.	33.3% 2/6 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.	50.0% 3/6 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.	20.0% 2/10 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.
Nervous system disorders Headache	33.3% 2/6 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.	0.00% 0/6 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.	0.00% 0/6 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.	0.00% 0/6 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.	16.7% 1/6 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.	10.0% 1/10 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.
Investigations Neutrophil count decreased	0.00% 0/6 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.	0.00% 0/6 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.	16.7% 1/6 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.	0.00% 0/6 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.	0.00% 0/6 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.	10.0% 1/10 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/6 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.	0.00% 0/6 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.	0.00% 0/6 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.	16.7% 1/6 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.	0.00% 0/6 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.	0.00% 0/10 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.
Musculoskeletal and connective tissue disorders Back pain	16.7% 1/6 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.	0.00% 0/6 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.	0.00% 0/6 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.	0.00% 0/6 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.	0.00% 0/6 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.	0.00% 0/10 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/6 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.	0.00% 0/6 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.	0.00% 0/6 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.	0.00% 0/6 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.	0.00% 0/6 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.	10.0% 1/10 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.
Infections and infestations Nasopharyngitis	0.00% 0/6 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.	33.3% 2/6 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.	0.00% 0/6 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.	0.00% 0/6 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.	0.00% 0/6 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.	10.0% 1/10 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.
Infections and infestations Gastroenteritis	0.00% 0/6 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.	16.7% 1/6 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.	0.00% 0/6 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.	0.00% 0/6 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.	0.00% 0/6 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.	0.00% 0/10 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/6 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.	0.00% 0/6 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.	16.7% 1/6 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.	16.7% 1/6 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.	0.00% 0/6 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.	0.00% 0/10 • Screening, Day1 to 7, Day 10, Day 17, and Day 30 An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.

Additional Information

Jiyeon Kang

Hanmi Pharmaceutical Co., Ltd.

Phone: 8224100377

Email: jiyeon.kang@hanmi.co.kr

Results disclosure agreements

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