A First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15211(Efocipegtrutide)

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Obesity

Treatments: Biological: HM15211 or Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03374241

HM-TRIA-101

Details and patient eligibility

About

Single ascending dose of HM15211 in healthy obese subjects.

Full description

A First-in-human study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics after single ascending dose of HM15211 in healthy obese subjects.

Enrollment: 41 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female subjects must be non-pregnant and non-lactating

Exclusion criteria

• Participation in an investigational study within 30 days prior to dosing

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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41 participants in 5 patient groups

Cohort 1

Experimental group

Description:

HM15211 or Placebo (single dose, subcutaneous injection)

Treatment:

Biological: HM15211 or Placebo

Cohort 2

Experimental group

Description:

HM15211 or Placebo (single dose, subcutaneous injection)

Treatment:

Biological: HM15211 or Placebo

Cohort 3

Experimental group

Description:

HM15211 or Placebo (single dose, subcutaneous injection)

Treatment:

Biological: HM15211 or Placebo

Cohort 4

Experimental group

Description:

HM15211 or Placebo (single dose, subcutaneous injection)

Treatment:

Biological: HM15211 or Placebo

Cohort 5

Experimental group

Description:

HM15211 or Placebo (single dose, subcutaneous injection)

Treatment:

Biological: HM15211 or Placebo