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

Overview

Single ascending dose of HM15211 in healthy obese subjects.

Full Title of Study: “A First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single Ascending Dose of HM15211 in Healthy Obese Subjects”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Sequential Assignment
  • Primary Purpose: Treatment
  • Masking: Triple (Participant, Care Provider, Investigator)
• Study Primary Completion Date: October 2018

Detailed Description

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

Interventions

• Biological: HM15211 or Placebo
  • Long-acting tri-agonist

Arms, Groups and Cohorts

• Experimental: Cohort 1
  • HM15211 or Placebo (single dose, subcutaneous injection)
• Experimental: Cohort 2
  • HM15211 or Placebo (single dose, subcutaneous injection)
• Experimental: Cohort 3
  • HM15211 or Placebo (single dose, subcutaneous injection)
• Experimental: Cohort 4
  • HM15211 or Placebo (single dose, subcutaneous injection)
• Experimental: Cohort 5
  • HM15211 or Placebo (single dose, subcutaneous injection)

Clinical Trial Outcome Measures

Primary Measures

• Number of participants with adverse events
  • Time Frame: 1 month
  • An adverse event is any undesirable and unintended medical event occurring to a subject in a clinical study, whether or not related to the investigational products

Participating in This Clinical Trial

Inclusion Criteria

• Female subjects must be non-pregnant and non-lactating Exclusion Criteria:

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • Hanmi Pharmaceutical Company Limited
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Hanmi Pharmaceuticals, Study Director, Hanmi Pharmaceuticals