Safety, Pharmacokinetic, Pharmacodynamic Study of LAPS-IFNa in Healthy Adult Subjects

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Biological: HM10660A; Biological: Pegasys; Biological: HM10660A placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01504581

11-HM10660A-101

Details and patient eligibility

About

Study design:

This is a randomized, double-blind, placebo- and active-controlled, single-dose study in 4 groups of 12 healthy male subjects each. In each group, 8 subjects will receive a dose of HM10660A, 2 subjects will receive a single dose of placebo and 2 subjects will receive a single dose of a currently marketed PEG-interferon.

Full description

Primary objective:

to study the safety and tolerability of HM10660A, including immunogenicity, as compared to PEG-interferon alpha-2a

Secondary objective:

to study the pharmacokinetics and pharmacodynamics of HM10660A as compared to PEG-interferon alpha-2a

Enrollment: 48 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age: 18 - 45 Years, Inclusive
• BMI: 18.0 - 28.0 kg/m2
• Are Non-smokers or Smoker of Fewer Than 5 Cigarettes Per Day as Determined by History

Exclusion criteria

• Mental Handicap
• Evidence of Clinically Relevant Pathology
• History of Type 1 Diabetes or Thyroid Disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 3 patient groups, including a placebo group

HM10660A

Experimental group

Treatment:

Biological: HM10660A

Pegasys

Active Comparator group

Treatment:

Biological: Pegasys

HM10660A Placebo

Placebo Comparator group

Treatment:

Biological: HM10660A placebo