First-in-Human Single Ascending Dose of SHR0302

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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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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