A Phase 1, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Ascending Intravenous and Subcutaneous Single-Dose Study in Healthy Subjects and Ascending Subcutaneous Multiple-Dose Study in Subjects With Type 2 Diabetes Mellitus to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immune Response of CNTO 3649
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Centocor, Inc.
- Enrollment
- 133
- Primary Endpoint
- Safety and tolerability of a single IV or SC administration of CNTO 3649 in healthy participants; Safety and tolerability of multiple SC injections of CNTO 3649 in Type 2 Diabetic Patients
Study Overview
Brief Summary
The purpose of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of CNTO 3649 following a single dose in healthy adults and following multiple doses in patients with Type 2 Diabetes Mellitus.
Detailed Description
This is a randomized (study medication assigned by chance), placebo controlled, double-blind (neither physician nor patient knows the name of the assigned study medication), ascending-dose study to assess the safety, tolerability, immune response, pharmacokinetics (what the body does to the drug), and pharmacodynamics (what the drug does to the body) of CNTO 3649. The study population will consist of approximately 80 healthy participants (Part 1) and approximately 36 type 2 diabetic patients (Part 2). All participants will be randomized to CNTO 3649 or placebo in the ratio of 3:1. Out of 80 healthy participants, 48 participants will receive single doses of CNTO 3649 (6 dose levels) or placebo as an intravenous infusion (directly into a vein) and 32 participants will receive single doses of CNTO 3649 (4 dose levels) or placebo as a subcutaneous (under the skin) injection. All 36 diabetic patients will receive multiple doses of CNTO 3649 (3 dose levels) or placebo as subcutaneous injections. There will be a screening period of 30 days and 45 days for healthy participants and diabetes patients, respectively. Healthy participants will be in the study for 9 weeks. Diabetic patients will be in the study for 12 weeks.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Part 1 (healthy participants): Demonstrate an understanding of the study and sign an informed consent form
- •Healthy male or female subjects with no clinically relevant abnormalities as determined by medical history, physical examination, blood chemistry assessments, hematologic assessments including complete blood count, coagulation tests, urinalysis, measurement of vital signs, and ECG
- •Age 18 to 55
- •Have a body mass index (BMI) of 18.5 to 30 kg/m2 and weight of 50 to 100 kg
- •Part 2 (patients with type 2 diabetes): Type 2 Diabetic male or female subjects diagnosed at least 12 months prior to screening and are stably managed for >= 3 months
- •HbA1c levels within the range of 6% to 10% if being treated with diet and exercise alone, and 6% to 9% if on therapy
- •BMI 18.5 to 37 kg/m
- •Age 18 to 65 years.
Exclusion Criteria
- •Part 1 (healthy participants): Currently have or have a history of any clinically significant medical illness or medical disorders the investigator considers should exclude the subject
- •Part 2 (patients with type 2 diabetes): Any clinically significant medical illness or medical disorders (with the exception of diagnosis of T2DM, well-controlled hypertension, or well-controlled dyslipidemia) the investigator considers should exclude the subject. History of more than 3 days of insulin use in the last 3 months, or any thiazolidinedione medications, any alpha glucosidase inhibitors, or exenatide within 3 months of the screening visit. History of clinically significant acute or chronic diabetic complications. History of severe hypoglycemic reaction in the 6 months prior to the screening visit.
Arms & Interventions
CNTO 3649 IV (Healthy participants)
Intervention: CNTO 3649 IV (Healthy participants) (Drug)
CNTO 3649 IV (Healthy participants)
Intervention: Placebo (Drug)
CNTO 3649 SC (Healthy participants)
Intervention: CNTO 3649 SC (Healthy participants) (Drug)
CNTO 3649 SC (Healthy participants)
Intervention: Placebo (Drug)
CNTO 3649 SC (Diabetic patients)
Intervention: CNTO 3649 SC (Diabetic patients) (Drug)
CNTO 3649 SC (Diabetic patients)
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Safety and tolerability of a single IV or SC administration of CNTO 3649 in healthy participants; Safety and tolerability of multiple SC injections of CNTO 3649 in Type 2 Diabetic Patients
Time Frame: Week 1 to Week 5 (for healthy participants) and Week 1 to Week 8 (for diabetic patients)
Secondary Outcomes
- Pharmacokinetics, pharmacodynamics and immunogenicity of CNTO 3649 following single and multiple administrations.(Week 1 to Week 5 (for healthy participants) and Week 1 to Week 8 (for diabetic patients))