A Phase 1, Randomized, 3-Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of CC-92252 in Healthy Adult Subjects and Adult Subjects With Psoriasis.
Overview
- Phase
- Phase 1
- Intervention
- CC-92252
- Conditions
- Healthy Volunteers
- Sponsor
- Celgene
- Enrollment
- 131
- Locations
- 1
- Primary Endpoint
- Adverse Events (AEs)
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
Brief Summary
This is a phase 1, randomized, single-center, 3-part, study to assess the safety, tolerability, PK, and PD, of single and multiple doses of CC-92252 in healthy adult subjects and multiple doses of CC-92252 in adult subjects with psoriasis.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects must satisfy the following criteria to be enrolled in the study:
- •Part 1, Part 2, and Part 3
- •Subject is ≥ 18 and ≤ 55 years (Part 1 and Part 2) and age is ≥ 18 and ≤ 60 years (Part 3) of age at the time of signing the ICF.
- •Subject has provided informed consent prior to initiation of any study specific activities/procedures
- •Subject has a body mass index (BMI) ≥ 18 and ≤ 30 kg/m2 (Part 1 and Part 2) and BMI ≥ 18 and ≤ 33 kg/m2 (Part 3), at screening.
- •Subject has clinical laboratory safety test results that are within normal limits or considered not clinically significant by the Investigator.
- •Applicable to Part 3 only
- •Subject has a clinical diagnosis of stable plaque-type PsO at least 6 months prior to screening, defined as:
- •BSA ≥ 5% (at both screening and baseline), and sPGA score ≥ 3 (at both screening and baseline)
- •Must have at least two plaques, at least 3 x 3 centimeters (cm) in diameter. One plaque will be used for punch biopsy and the other for Target Plaque Severity Score (TPSS) evaluation.
Exclusion Criteria
- •The presence of any of the following will exclude a subject from enrollment:
- •Part 1, Part 2, and Part 3
- •Subject has any significant medical condition that would prevent the subject from participating in the study.
- •a. Part 3 only: This exclusion does not apply to plaque psoriasis
- •History or presence of cancer
- •Presence of pre-cancerous conditions
- •History or presence of a systemic infection or any potentially opportunistic infections
- •Subject has any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
- •Subject has any condition that confounds the ability to interpret data from the study
- •Subject is pregnant or breastfeeding
Arms & Interventions
Administration of CC-92252 and Placebo in Healthy Subjects
Part 1 of the study will be conducted as a single ascending dose study, each cohort will consist of 9 subjects. Part 2 of the study will be conducted as a multiple ascending dose study, each cohort will consist of 8 subjects. In part 3, subjects with psoriasis will receive CC-92252 or placebo for up to 12 weeks.
Intervention: CC-92252
Administration of CC-92252 and Placebo in Healthy Subjects
Part 1 of the study will be conducted as a single ascending dose study, each cohort will consist of 9 subjects. Part 2 of the study will be conducted as a multiple ascending dose study, each cohort will consist of 8 subjects. In part 3, subjects with psoriasis will receive CC-92252 or placebo for up to 12 weeks.
Intervention: Placebo
Administration of CC-92252 and Placebo in Psoriasis subjects
Part 1 of the study will be conducted as a single ascending dose study, each cohort will consist of 9 subjects. Part 2 of the study will be conducted as a multiple ascending dose study, each cohort will consist of 8 subjects. In part 3, subjects with psoris will receive CC-92252 or placebo for up to 12 weeks.
Intervention: CC-92252
Administration of CC-92252 and Placebo in Psoriasis subjects
Part 1 of the study will be conducted as a single ascending dose study, each cohort will consist of 9 subjects. Part 2 of the study will be conducted as a multiple ascending dose study, each cohort will consist of 8 subjects. In part 3, subjects with psoris will receive CC-92252 or placebo for up to 12 weeks.
Intervention: Placebo
Outcomes
Primary Outcomes
Adverse Events (AEs)
Time Frame: From enrollment until at least 28 days after completion of study treatment
Number of participants with adverse event
Secondary Outcomes
- Pharmacokinetics - t1/2z(UP to 16 weeks)
- Pharmacokinetics - CL/F(Up to 16 weeks)
- Anti-drug Antibody Immunogenicity Anti-drug antibody(Up to 16 weeks)
- Pharmacokinetics - CL(Up to 16 weeks)
- Pharmacokinetics - Cmax(Up to 16 weeks)
- Pharmacokinetics - AUC0-t(Up to 16 weeks)
- Pharmacokinetics - AUC0-∞(Up to 16 weeks)
- Pharmacokinetics - Tmax(Up to 16 weeks)
- Pharmacokinetics - Vz/F(Up to 16 weeks)
- Pharmacokinetics - Vz(Up to 16 weeks)
- Assessment of Pharmacodynamic biomarkers(UP to 24 weeks)