First-in-Human Single Ascending Dose of SHR0302

Hengrui Medicine

Status and phase: Unknown; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Drug: SHR0302 placebo comparator; Drug: SHR0302

Study type: Interventional

Funder types: Industry

Identifiers

NCT02423538

SHR0302-101

Details and patient eligibility

About

The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) oral doses of SHR0302 compared to placebo. Also, pharmacokinetics (PK) and pharmacodynamics (PD) of SHR0302 after single oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.

Enrollment: 64 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy subjects, age 18-45 years (inclusive);
• The weight of the subject should be more than 50 kg, body mass index (BMI = weight/height squared (kg/m2)) within the range of 19 to 24.

Exclusion criteria

• Any condition that might interfere with the procedures or tests in the study
• History of heart failure or renal insufficiency
• Smoking; Drug or alcohol abuse

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups, including a placebo group

single ascending doses

Experimental group

Description:

single ascending doses, oral tablets

Treatment:

Drug: SHR0302

Placebo

Placebo Comparator group

Description:

Placebo Comparator, oral tablets

Treatment:

Drug: SHR0302 placebo comparator