First-in-Human Single Ascending Dose of SHR0302

NCT02423538 | Unknown Phase 1

• 1 other identifier: SHR0302-101
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

single ascending doses

EXPERIMENTAL

single ascending doses, oral tablets

Drug: SHR0302

Placebo

PLACEBO COMPARATOR

Placebo Comparator, oral tablets

Drug: SHR0302 placebo comparator

Interventions

SHR0302 DRUG

Oral tablets (1 mg, 5 mg, 10 mg)

single ascending doses

SHR0302 placebo comparator DRUG

Oral tablets (1 mg, 5 mg, 10 mg) (matching corresponding study medication)

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

First Affiliated Hospital of Fourth Military Medical University

Xi’an, Shanxi, 710032, China

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

ivarmacitinib

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2015
• First Posted: April 22, 2015
• Study Start: April 1, 2015
• Primary Completion: July 1, 2016
• Last Updated: January 26, 2016

Record last verified: 2016-01

Locations

CN (1)