PharmacologyPhase 1NCT04076293

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

A Phase 1 study testing HM15912 in people with Pharmacology, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A First-in-Human, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15912 in Healthy Korean Subjects Read more about this study

Who is it for?: Ages 19 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Pharmacology
What is being tested?: HM15912
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteSouth Korea
Study dates: 8 Oct 2019to 3 May 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Subject voluntarily agrees to participate in this study and signs an IRB-approved informed consent prior to performing any of the Screening visit procedures.
Korean males and females ≥ 19 and ≤ 60 years of age at the Screening visit

Who cannot join

Subject with a history or presence of clinically significant active diseases.
Subject who has participated in other clinical studies (including bioequivalence tests) within 6 months before the Screening visit and has received IPs

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Asan Medical Center
Seoul, 05505

Other trials in South Korea

About this study

Official title: A First-in-Human, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15912(Sonefpeglutide) in Healthy Korean Subjects

A First-in-Human, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15912 in Healthy Korean Subjects

Conditions: Pharmacology
Being tested: HM15912, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HM15912Drug
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).
PlaceboDrug
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).

Study groups in NCT04076293
Study group	Role	What they receive
HM15912	Experimental	Not described Receives: Drug: HM15912
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Treatment-emergent Adverse Events of HM15912
Number of participants with any treatment-emergent adverse events related to study medication.
Measured: after single subcutaneous (SC) doses for 44 days
Number of Participants With Significant Findings Observed for Hematology
Measured: after single subcutaneous (SC) doses for 44 days

Secondary outcomes (1)

Concentration Max Profile of HM15912
To assess the Concentration Max profile of HM15912 after single SC doses.
Measured: after single subcutaneous (SC) doses at day 1,2,3,4,5,6,7,10,17 and 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Oct 20193 May 2021

First posted3 Sep 2019
Study start8 Oct 2019
Primary completion10 Nov 2020
Study completion3 May 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PharmacologyStudies of the same condition, open and under way.
More trials run by Hanmi Pharmaceutical Company LimitedThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04076293
Sponsor's protocol ID: HM-GLP2-101
Status last verified: Jan 2025
First submitted: 26 Aug 2019
Last updated: 10 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A First-in-Human, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15912(Sonefpeglutide) in Healthy Korean Subjects
ClinicalTrials.gov ID: NCT04076293
Acronym / sponsor ID: HM-GLP2-101
Conditions: Pharmacology
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
Study start: 8 Oct 2019 (actual)
Primary completion: 10 Nov 2020 (actual)
Study completion: 3 May 2021 (actual)
First posted: 3 Sep 2019 (actual)
Results: Posted 10 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A First-in-Human, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15912 in Healthy Korean Subjects

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
HM15912	Experimental	Drug: HM15912
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 19 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Subject voluntarily agrees to participate in this study and signs an IRB-approved informed consent prior to performing any of the Screening visit procedures.
Korean males and females ≥ 19 and ≤ 60 years of age at the Screening visit

Key exclusion criteria (2 listed)

Subject with a history or presence of clinically significant active diseases.
Subject who has participated in other clinical studies (including bioequivalence tests) within 6 months before the Screening visit and has received IPs

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HM15912The 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).	Drug	HM15912
PlaceboThe 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).	Drug	Placebo

Primary outcome

Number of Participants With Treatment-emergent Adverse Events of HM15912
Time frame: after single subcutaneous (SC) doses for 44 days
Number of participants with any treatment-emergent adverse events related to study medication.
Number of Participants With Significant Findings Observed for Hematology
Time frame: after single subcutaneous (SC) doses for 44 days

1 secondary outcome

Concentration Max Profile of HM15912
Time frame: after single subcutaneous (SC) doses at day 1,2,3,4,5,6,7,10,17 and 30

Results and safety

Results posted to the registry on 10 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HM15912 0.05mg/kg	6	6
HM15912 0.1mg/kg	6	6
HM15912 0.5mg/kg	6	6
HM15912 1.0mg/kg	6	6
HM15912 1.5mg/kg	6	6
Placebo	10	10

Primary outcome: Number of Participants With Treatment-emergent Adverse Events of HM15912

Time frame: after single subcutaneous (SC) doses for 44 days. Count of participants. Unit: Participants

Measure	HM15912 0.05mg/kg n = 6	HM15912 0.1mg/kg n = 6	HM15912 0.5mg/kg n = 6	HM15912 1.0mg/kg n = 6	HM15912 1.5mg/kg n = 6	Placebo n = 10
Mild TEAE	3	1	2	4	4	5
Moderate TEAE	0	2	0	0	0	1
No AE	3	3	4	2	2	4

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

Primary outcome: Number of Participants With Significant Findings Observed for Hematology

Time frame: after single subcutaneous (SC) doses for 44 days. Count of participants. Unit: Participants

Measure	HM15912 0.05mg/kg n = 6	HM15912 0.1mg/kg n = 6	HM15912 0.5mg/kg n = 6	HM15912 1.0mg/kg n = 6	HM15912 1.5mg/kg n = 6	Placebo n = 10
Value	0	0	0	0	0	0

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Screening, Day1 to 7, Day 10, Day 17, and Day 30. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HM15912 0.05mg/kg	0 of 6 (0%)	3 of 6 (50%)	0 of 6
HM15912 0.1mg/kg	0 of 6 (0%)	3 of 6 (50%)	0 of 6
HM15912 0.5mg/kg	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
HM15912 1.0mg/kg	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
HM15912 1.5mg/kg	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Placebo	0 of 10 (0%)	6 of 10 (60%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HM15912 in people with Pharmacology, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-emergent Adverse Events of HM15912 (time frame: after single subcutaneous (SC) doses for 44 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04076293.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.