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First-in-Human Single Ascending Dose of SHR0302

Sponsor
Jiangsu HengRui Medicine Co., Ltd. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT02423538
Collaborator
(none)
64
Enrollment
1
Location
2
Arms

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase I, Randomized, Placebo-Controlled, Single Dose Escalation Study to Investigate Safety, Pharmacokinetics and Pharmacodynamics of SHR0302 in Healthy Volunteers
Study Start Date :
Apr 1, 2015
Anticipated Primary Completion Date :
Jul 1, 2016

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  3. The area under the plasma concentration-time curve (AUC) of SHR0302 [At protocol-specified times up to 72 hrs postdose]

  4. t1/2 of SHR0302 [At protocol-specified times up to 72 hrs postdose]

  5. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 First Affiliated Hospital of Fourth Military Medical University Xi'an Shanxi China 710032

Sponsors and Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:
NCT02423538
Other Study ID Numbers:
  • SHR0302-101
First Posted:
Apr 22, 2015
Last Update Posted:
Jan 26, 2016
Last Verified:
Jan 1, 2016
Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid

Study Results

No Results Posted as of Jan 26, 2016