This trial is active, not recruiting.

Condition rheumatoid arthritis
Treatments shr0302, shr0302 placebo comparator
Phase phase 1
Sponsor Jiangsu HengRui Medicine Co., Ltd.
Start date April 2015
End date July 2016
Trial size 64 participants
Trial identifier NCT02423538, SHR0302-101


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
single ascending doses, oral tablets
Oral tablets (1 mg, 5 mg, 10 mg)
(Placebo Comparator)
Placebo Comparator, oral tablets
shr0302 placebo comparator
Oral tablets (1 mg, 5 mg, 10 mg) (matching corresponding study medication)

Primary Outcomes

Adverse events and the number of volunteers with adverse events as a measure of safety and tolerability.
time frame: up to 72 hrs postdose
The maximum plasma concentration (Cmax) of SHR0302
time frame: At protocol-specified times up to 72 hrs postdose
The area under the plasma concentration-time curve (AUC) of SHR0302
time frame: At protocol-specified times up to 72 hrs postdose
t1/2 of SHR0302
time frame: At protocol-specified times up to 72 hrs postdose
Pharmacodynamics (PD)parameters of percent and actual change from baseline for a panel of JAK-dependent biomarkers
time frame: At protocol-specified times up to 24 hrs postdose

Eligibility Criteria

Male or female participants from 18 years up to 45 years old.

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

Additional Information

Official title A Phase I, Randomized, Placebo-Controlled, Single Dose Escalation Study to Investigate Safety, Pharmacokinetics and Pharmacodynamics of SHR0302 in Healthy Volunteers
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Jiangsu HengRui Medicine Co., Ltd..