A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of CC-99677 in Healthy Adult Subjects

Summary

This is a phase 1, randomized, single-center, 3-part, FIH study to assess the safety, tolerability, pharmacokinetics (PK, or how the drug behaves in the body), and pharmacodynamics (PD, or what the drug does to the body) of single and multiple doses of CC-99677 and to characterize the effect of food on the single-dose PK of CC-99677 in healthy adult subjects.

Timeline

Start

2018-05-23

Primary completion

2019-07-03

Completion

2019-07-03

Publications

• Gaur R, Mensah KA, Stricker J, Adams M, Parton A, Cedzik D, Connarn J, Thomas M, Horan G, Schafer P, Mair S, Palmisano M, Ramirez-Valle F. CC-99677, a novel, oral, selective covalent MK2 inhibitor, sustainably reduces pro-inflammatory cytokine production. Arthritis Res Ther. 2022 Aug 18;24(1):199. doi: 10.1186/s13075-022-02850-6.
• Malona J, Chuaqui C, Seletsky BM, Beebe L, Cantin S, Kalken DV, Fahnoe K, Wang Z, Browning B, Szabo H, Koopman LA, Oravecz T, McDonald JJ, Ramirez-Valle F, Gaur R, Mensah KA, Thomas M, Connarn JN, Hu H, Alexander MD, Corin AF. Discovery of CC-99677, a selective targeted covalent MAPKAPK2 (MK2) inhibitor for autoimmune disorders. Transl Res. 2022 Nov;249:49-73. doi: 10.1016/j.trsl.2022.06.005. Epub 2022 Jun 9.

Drugs

Indications

No indication recorded.