First-in-Human Single Ascending Dose of SHR0302

A Phase I, Randomized, Placebo-Controlled, Single Dose Escalation Study to Investigate Safety, Pharmacokinetics and Pharmacodynamics of SHR0302 in Healthy Volunteers

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.

Study Overview

• Status: Unknown
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: SHR0302; Drug: SHR0302 placebo comparator

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanxi
    • Xi'an, Shanxi, China, 710032
      • First Affiliated Hospital of Fourth Military Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: single ascending doses; single ascending doses, oral tablets	Drug: SHR0302; Oral tablets (1 mg, 5 mg, 10 mg)
PLACEBO_COMPARATOR: Placebo; Placebo Comparator, oral tablets	Drug: SHR0302 placebo comparator; Oral tablets (1 mg, 5 mg, 10 mg) (matching corresponding study medication)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events and the number of volunteers with adverse events as a measure of safety and tolerability.	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.	up to 72 hrs postdose
The maximum plasma concentration (Cmax) of SHR0302	Blood samples are taken on various timepoints to assess the pharmacokinetic parameters	At protocol-specified times up to 72 hrs postdose
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
Pharmacodynamics (PD)parameters of percent and actual change from baseline for a panel of JAK-dependent biomarkers	To characterize the effects of SHR0302 on mechanism of action-related biomarkers in the blood over time - pharmacodynamics (PD) - in healthy volunteers.	At protocol-specified times up to 24 hrs postdose

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (ANTICIPATED): July 1, 2016

Study Registration Dates

• First Submitted: April 7, 2015
• First Submitted That Met QC Criteria: April 17, 2015
• First Posted (ESTIMATE): April 22, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): January 26, 2016
• Last Update Submitted That Met QC Criteria: January 24, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: SHR0302-101