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

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Pharmacology

Treatments: Drug: Placebo; Drug: HM15912

Study type: Interventional

Funder types: Industry

Identifiers

NCT04076293

HM-GLP2-101

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 19 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

HM15912

Experimental group

Treatment:

Drug: HM15912

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo