First-in-Human Single Ascending Dose of SHR0302

Phase 1

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: SHR0302 placebo comparator; Drug: SHR0302

• Registration Number: NCT02423538
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-07
• Study First Submitted QC: 2015-04-17
• Study First Posted: 2015-04-22
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-24
• Last Update Posted: 2016-01-26
• Primary Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	SHR0302 placebo comparator	Placebo Comparator, oral tablets
single ascending doses	SHR0302	single ascending doses, oral tablets

Primary Outcome Measures

Name	Time	Method
Pharmacodynamics (PD)parameters of percent and actual change from baseline for a panel of JAK-dependent biomarkers	At protocol-specified times up to 24 hrs postdose	To characterize the effects of SHR0302 on mechanism of action-related biomarkers in the blood over time - pharmacodynamics (PD) - in healthy volunteers.
The maximum plasma concentration (Cmax) of SHR0302	At protocol-specified times up to 72 hrs postdose	Blood samples are taken on various timepoints to assess the pharmacokinetic parameters
The area under the plasma concentration-time curve (AUC) of SHR0302	At protocol-specified times up to 72 hrs postdose
t1/2 of SHR0302	At protocol-specified times up to 72 hrs postdose
Adverse events and the number of volunteers with adverse events as a measure of safety and tolerability.	up to 72 hrs postdose	Tests will be performed to assess whether the study drug has any potentially adverse effect (laboratory tests on blood and urine for functioning of organs; cardiovascular testing, i.e. of heart and blood circulation). Also, participants will carefully be monitored by medical staff for vital signs, and asked to report any side effect experienced in the course of the study.

Trial Locations

Locations (1)

First Affiliated Hospital of Fourth Military Medical University; 🇨🇳 Xi'an, Shanxi, China