NCT03554993

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

Completed Phase 1 Last updated 26 February 2020

What this trial tests

Phase 1 trial testing CC-99677 in Healthy Volunteer in 97 participants. Completed in 3 July 2019.

Timeline

23 May 2018

Primary endpoint
3 July 2019

3 July 2019

Quick facts

Lead sponsor	Celgene
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	97
Start date	23 May 2018
Primary completion	3 July 2019
Estimated completion	3 July 2019
Sites	1 location across United Kingdom

Drugs / interventions tested

• CC-99677 — full drug profile →
• Placebo

Conditions studied

• Healthy Volunteer — all drugs for Healthy Volunteer →

Sponsor

Celgene — full company profile →

Who can join

Adults 18 to 55, any sex, with Healthy Volunteer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Protein kinases: drug targets for immunological disorders.
   Castelo-Soccio L, Kim H, Gadina M, Schwartzberg PL, et al · · 2023 · cited 67× · PMID 37188939 · DOI 10.1038/s41577-023-00877-7
2. CC-99677, a novel, oral, selective covalent MK2 inhibitor, sustainably reduces pro-inflammatory cytokine production.
   Gaur R, Mensah KA, Stricker J, Adams M, et al · · 2022 · cited 22× · PMID 35982464 · DOI 10.1186/s13075-022-02850-6