NCT04032782

Brief Summary

This is a double-blind, randomized, placebo controlled, single ascending dose (SAD) study to investigate the safety, tolerability, PK and PD of the SC administration of HM15136 in healthy subjects. The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15136 or placebo in a ratio of 6:2 (6 active, 2 placebo).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 2, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2018

Completed
8 months until next milestone

First Posted

Study publicly available on registry

July 25, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2019

Completed
Last Updated

February 5, 2025

Status Verified

February 1, 2025

Enrollment Period

11 months

First QC Date

November 16, 2018

Last Update Submit

February 3, 2025

Conditions

Pharmacology

Outcome Measures

Primary Outcomes (1)

  • Adverse Event

    Incidence of adverse events

    Day 30

Study Arms (2)

HM15136

EXPERIMENTAL
Drug: HM15136

Placebo of HM15136

PLACEBO COMPARATOR
Drug: Placebo of HM15136

Interventions

HM15136DRUG

10 mg/mL as protein in prefilled syringes

HM15136
Placebo of HM15136DRUG

Placebo in prefilled syringes

Placebo of HM15136

Eligibility Criteria

Age19 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index ≥ 18.5 and ≤ 27 kg/m2 and with a weight ≥ 50 kg

You may not qualify if:

  • with personal or family history of hypercoagulability or thromboembolic disease
  • has had treatment with any incretin therapy
  • has FPG \< 70 or \> 110 mg/dL

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

HM15136

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2018

First Posted

July 25, 2019

Study Start

October 2, 2018

Primary Completion

August 29, 2019

Study Completion

August 29, 2019

Last Updated

February 5, 2025

Record last verified: 2025-02

Locations

KR(1)