First-in-Human Single Ascending Dose of SHR0302

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Multiple Doses Escalation Study of SHR0302 in Rheumatoid Arthritis (RA) Patients

NCT02665910

Rheumatoid Arthritis

UNKNOWN PHASE1

A Phase Ⅰ Clinical Trial to Evaluate the Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of SHR-3045 in Healthy Subjects

NCT06883695

Rheumatoid Arthritis

ACTIVE_NOT_RECRUITING PHASE1

The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of SHR-3045 in Healthy Subjects

NCT07200596

Rheumatoid Arthritis (RA)

RECRUITING PHASE1

A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Rheumatoid Arthritis

NCT04333771

Rheumatoid Arthritis

COMPLETED PHASE3

Study of SHR0302 Tablets (SHR0302) as Monotherapy in Active Rheumatoid Arthritis (RA) Patients

NCT03254966

Rheumatoid Arthritis

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rheumatoid Arthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

single ascending doses

single ascending doses, oral tablets

Group Type EXPERIMENTAL

SHR0302

Intervention Type DRUG

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

Placebo

Placebo Comparator, oral tablets

Group Type PLACEBO_COMPARATOR

SHR0302 placebo comparator

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SHR0302

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

Intervention Type DRUG

SHR0302 placebo comparator

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes