The First Clinical Study to Test Safety, Blood Levels and Other Effects of CDP6038 in Healthy Males

UCB

Status and phase

Completed

Phase 1

Conditions

Pharmacokinetics

Treatments

Biological: CDP6038

Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01276119

RA0001

Details and patient eligibility

About

To evaluate the safety, tolerability, blood levels and effects of CDP6038 administered by intravenous infusion (iv) and subcutaneous (sc) injection.

Enrollment

67 patients

Sex

Male

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Body mass index between 19.0 and 28.0 kg/m² and body weight between ≥ 50 kg and ≤ 120 kg

Exclusion criteria

Previous trial participation or blood donation/loss within 3 months
Subject is not healthy (eg significant medical history, taking drug treatments, any psychological or emotional problems, or drug or alcohol abuse (current or historical)
Plans for or actual vaccination within 3 months
Previous drug treatments
Tobacco use or heavy caffeine consumption
Systolic blood pressure <90 or >145mmHg, diastolic blood pressure <40 or >90mmHg or heart rate <45 or >90 beats per minute

Trial design

67 participants in 14 patient groups, including a placebo group

Cohort A, CDP6038 0.001 mg/kg, iv

Experimental group

Treatment:

Biological: CDP6038

Cohort B, CDP6038 0.01 mg/kg, iv

Experimental group

Treatment:

Biological: CDP6038

Cohort C, CDP6038 0.03 mg/kg, iv

Experimental group

Treatment:

Biological: CDP6038

Cohort D, CDP6038 0.1 mg/kg, iv

Experimental group

Treatment:

Biological: CDP6038

Cohort E, CDP6038 0.3 mg/kg, iv

Experimental group

Treatment:

Biological: CDP6038

Cohort G, CDP6038 1.0 mg/kg, iv

Experimental group

Treatment:

Biological: CDP6038

Cohort I, CDP6038 3.0 mg/kg, iv

Experimental group

Treatment:

Biological: CDP6038

Cohort K, CDP6038 10.0 mg/kg, iv

Experimental group

Treatment:

Biological: CDP6038

Cohort A, Placebo, iv

Placebo Comparator group

Treatment:

Other: Placebo

Cohort B, C, D, E, G, I, K, Placebo, iv

Placebo Comparator group

Treatment:

Other: Placebo

Cohort F, CDP6038 0.3 mg/kg, sc

Experimental group

Treatment:

Biological: CDP6038

Cohort H, CDP6038 1.0 mg/kg, sc

Experimental group

Treatment:

Biological: CDP6038

Cohort J, CDP6038 3.0 mg/kg, sc

Experimental group

Treatment:

Biological: CDP6038

Cohort F, H, J, Placebo, sc

Placebo Comparator group

Treatment:

Other: Placebo

Trial contacts and locations

1

Loading...