First-in-Human Single Ascending Dose of SHR0302

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02423538
• Other study ID #: SHR0302-101
• Status: Active, not recruiting
• Phase: Phase 1
• First received: April 7, 2015
• Last updated: January 24, 2016
• Start date: April 2015

Study information

• Verified date: January 2016
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 64
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• SHR0302
Oral tablets (1 mg, 5 mg, 10 mg)
• SHR0302 placebo comparator
Oral tablets (1 mg, 5 mg, 10 mg) (matching corresponding study medication)

Locations

Country	Name	City	State
China	First Affiliated Hospital of Fourth Military Medical University	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	No
Primary	The area under the plasma concentration-time curve (AUC) of SHR0302		At protocol-specified times up to 72 hrs postdose	No
Primary	t1/2 of SHR0302		At protocol-specified times up to 72 hrs postdose	No
Primary	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	No