A Study of MCAF5352A in Healthy Volunteers

A Phase Ib, Single-Center, Randomized, Placebo-Controlled, Double-Blind Multiple Ascending-Dose Study to Investigate the Safety, Pharmacokinetics, and Immunogenicity of Subcutaneous MCAF5352A in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01540760

Enrollment

Registered

2012-02-29

Start date

2012-03-31

Completion date

2012-09-30

Last updated

2016-11-02

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

Conditions

Healthy Volunteer

Brief summary

This single-center, randomized, placebo-controlled, double-blind, multiple ascending dose study will evaluate the safety, pharmacokinetics and immunogenicity of MCAF5352A in healthy volunteers. Subjects will be randomized to receive either MCAF5352A or placebo on Days 1, 15 and 29.

Interventions

DRUGMCAF5352A

Multiple ascending doses

DRUGPlacebo

Matching MCAF5352A, multiple doses

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy males and females, 18 - 55 years of age * Subjects in good health as determined by screening medical history, physical examination, vital signs, 12-lead ECG and laboratory tests * Body weight between 45 kg and 110 kg * Female subjects must be willing to use two effective methods of contraception from screening to a minimum of 4 months after the last dose of study drug

Exclusion criteria

* Pregnant or lactating women * Positive for hepatitis B, hepatitis C or HIV infection * History of significant chronic or recurrent infections * History of clinically significant drug allergy and/or a known hypersensitivity to protein therapeutics or formulation components or a related drug * History of alcohol or drug abuse within 12 months prior to Day 1, or evidence of such abuse * Subjects who have previously received the study drug * Participation in a clinical trial within 4 weeks prior to Day 1 or use of any experimental or biologic therapy within 12 weeks prior to Day 1 or within 5 half-lives of the product, whichever is greater

Design outcomes

Primary

Measure	Time frame
Safety: Incidence of adverse events	approximately 5 months

Secondary

Measure	Time frame
Pharmacokinetics: Area under the concentration-time curve	Pre-dose and 5 time points up to 14 days post-dose
Immunogenicity: Serum MCAF5252A antibodies	Days 1, 29, 50, 78, 106 and 134

Countries

Canada

Outcome results

None listed

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