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A Multiple Ascending Dose Study of CSL112 in Healthy Volunteers

C

CSL Limited

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Biological: CSL112
Biological: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01281774
CSLCT-HDL-10-68

Details and patient eligibility

About

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of CSL112 in healthy volunteers after multiple infusions.

Enrollment

36 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy males and females aged 18 years to less than 55 years
  • Body weight 50kg or greater
  • Body mass index (BMI) between 18 and 42.0 kg/m2

Exclusion criteria

  • Evidence of a clinically significant medical condition, disorder or disease
  • Evidence of hepatobiliary disease
  • Any clinically relevant abnormal laboratory test result
  • Evidence or history of alcohol or substance abuse

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

36 participants in 2 patient groups, including a placebo group

CSL112
Experimental group
Description:
Multiple ascending intravenous doses of CSL112
Treatment:
Biological: CSL112
Placebo
Placebo Comparator group
Description:
Multiple intravenous infusions of placebo
Treatment:
Biological: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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