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

A Randomized, Double-Blind, Placebo- And Active-Controlled Study Of The Pharmacokinetics, Pharmacodynamics And Safety Of Single Ascending Doses Of HM10660A (LAPS-INTERFERON ALPHA-2B) In Healthy Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01504581

Enrollment

Registered

2012-01-05

Start date

2011-03-31

Completion date

Unknown

Last updated

2014-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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.

Detailed 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

Interventions

BIOLOGICALHM10660A

Single dose of HM10660A 1.5, 2.25, 3.0, or 4.0 ug/kg

BIOLOGICALHM10660A placebo

Single dose of HM10660A Placebo

BIOLOGICALPegasys

Single dose of Pegasys 180ug

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Number of participants with AE occurrence, clinically significant clinical lab, vital sign, and/or ECG change	43 days	Number of participants with AE occurrence, clinically significant clinical lab, vital sign, and/or ECG change among HM10660A receivers will be assessed. It can be compared to those numbers in Active comparator group.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026