A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CC-90006 in Healthy Subjects

Study Overview
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Brief Summary
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This is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of CC-90006 following administration of single subcutaneous doses in healthy subjects.

Detailed Description
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The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetic profile of single-ascending doses of CC-90006 in healthy subjects. This will be a placebo-controlled, single-ascending dose study of CC-90006. Approximately 40 subjects will be enrolled. Five dose levels are planned. Each dose level will enroll 8 subjects who will be assigned randomly to receive active CC-90006 (6 subjects) and placebo (2 subjects). Eligible subjects will check into the clinic site on the day before dosing (Day -1) and receive the assigned dose by subcutaneous injection the following day (Day 1). Subjects will be discharged from the site on Day 4 and return for visits on Days 8 (week 1), 15 (week 2), 22 (week 3), 29 (week 4), 36 (week 5), 43 (week 6), 57 (week 8), and 71 (week 10). Subjects will also be followed up via a phone call on Day 105 (week 15). Safety assessments will be performed and blood samples will be collected for determination of levels of CC-90006 in the blood.

Official Title
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A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CC-90006 in Healthy Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Placebo
* Drug: CC-90006


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and/or female subjects between the ages of 18 and 55 years, and a body mass index (BMI) of ≥ 18 and ≤ 33 kg/m2 with body weight ≥ 50 and ≤ 90 kg at screening. Females must have been surgically sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingo-oophorectomy; proper documentation required) at least 6 months before screening, or be postmenopausal (defined as 24 consecutive months without menses before screening, with a follicle-stimulating hormone [FSH] level of > 40 IU/L at screening). Exclusion Criteria: Exposure/treatment to an investigational (new chemical entity) or marketed drug or biologic within 30 days preceding the first dose administration, or five half-lives of that investigational drug or biologic, if known (whichever is longer). Donation blood or serum within 8 weeks before the first dose administration to a blood bank or blood donation center. History of alcohol or drug abuse (as defined by the current version of the DSM) within 2 years before the first dose administration, or positive alcohol or drug screen. Vaccination within 30 days prior to the first dose administration or has plans to receive a vaccination during the course of the study (including the follow phone call on Day 105).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CC-90006; Dose Level 1<br>CC-90006 will be administered by subcutaneous injection in the abdomen | Drug: CC-90006<br> <br> |
| Experimental: CC-90006; Dose Level 2<br>CC-90006 will be administered by subcutaneous injection in the abdomen | Drug: CC-90006<br> <br> |
| Experimental: CC-90006; Dose Level 3<br>CC-90006 will be administered by subcutaneous injection in the abdomen | Drug: CC-90006<br> <br> |
| Experimental: CC-90006; Dose Level 4<br>CC-90006 will be administered by subcutaneous injection in the abdomen | Drug: CC-90006<br> <br> |
| Experimental: CC-90006; Dose Level 5<br>CC-90006 will be administered by subcutaneous injection in the abdomen | Drug: CC-90006<br> <br> |
| Experimental: Placebo<br>Placebo will be administered by subcutaneous injection in the abdomen | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events (AEs) | Number of participants with adverse events | Up to day 105 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics- Cmax | Observed maximum serum concentration | Up to day 71 | 
| Pharmacokinetics- Tmax | Time to Observed maximum serum concentration | Up to day 71 | 
| Pharmacokinetics- AUC0-∞ | Area under the serum concentration-time curve calculated from time zero to infinity | Up to day 71 | 
| Pharmacokinetics- AUC0-t | Area under the serum concentration-time curve calculated from time zero to the last measured time point | Up to day 71 | 
| Pharmacokinetics- T1/2 | Terminal half-life (T1/2) | Up to day 71 | 
| Pharmacokinetics- CL/F | Apparent clearance of drug from serum when dosed subcutaneously | Up to day 71 | 
| Pharmacokinetics- Vz/F | Apparent volume of distribution when dosed subcutaneously during the terminal phase | Up to day 71 | 
| Pharmacokinetics- Anti-drug antibody | A measure of the body's immune response to CC-90006 | Up to day 71 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy subjects, Safety, CC-90006, Phase 1, Tolerability