Safety, Tolerability, PK and PD of CC-99677 in Healthy Subjects
Research type
Research Study
Full title
A Phase 1, Randomized, Single-Center, 3-Part, First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of CC-99677 in Healthy Adult Subjects
IRAS ID
240094
Contact name
Francisco Ramirez-Valle
Contact email
Sponsor organisation
Celgene Corporation, LLC
Eudract number
2017-004849-24
Duration of Study in the UK
0 years, 7 months, 21 days
Research summary
CC‑99677 is a test medicine that is being developed by Celgene Corporation to treat inflammatory diseases. Inflammation is part of the body’s normal response to infections and injury, but in some cases the inflammation is unexplained and uncontrolled and can cause damage.Inflammatory diseases are associated with redness, pain, and swelling in the affected tissues. An example of an inflammatory disease is ankylosing spondylitis, which is a relatively rare form of arthritis that causes inflammation of the spine and certain joints.
This is the first time CC-99677 will be dosed in humans.
The study will try to identify the safety, tolerability, pharmacokinetics (PK; how well CC-99677 is taken up by the body), and pharmacodynamics (PD; the effects of CC-99677 on the body) of single and multiple doses of CC-99677 given by mouth in healthy subjects. The effect of food on PK will also be assessed.
The study will consist of 3 parts. In Part 1 approximately 48 subjects will receive a single dose of CC-99677 or placebo (dummy drug). Subjects will be split into 6 groups and it’s planned that each group will receive a higher dose than the previous group.
In Part 2 approximately 40 additional subjects will receive multiple doses of CC-99677 or placebo. Subjects will be split into 5 groups and it’s planned that each group will receive higher doses than the previous group. Part 2 will begin only once a review of safety and PK data from the first 3 dose levels in Part 1 has determined it safe to do so.
In both Parts, administration of a higher doses will only begin once a review of safety and PK data has determined it safe to do so.
In Part 3 approximately 12 additional subjects will receive a single dose of CC-99677 in the fed and fasted state. Part 3 will begin only once a review of safety and PK data from the first 5 dose levels in Part 1 has determined it safe to do so.
REC name
London - Riverside Research Ethics Committee
REC reference
18/LO/0588
Date of REC Opinion
26 Apr 2018
REC opinion
Further Information Favourable Opinion