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Clinical Trials/NCT04457856
NCT04457856UnknownPhase 1

A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dose and Multiple Ascending Doses of TJ003234 in Rheumatoid Arthritis Patients

I-Mab Biopharma US Limited5 sites in 1 country63 target enrollmentStarted: August 6, 2020Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Enrollment
63
Locations
5
Primary Endpoint
Number of subject with adverse events(AEs)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Study Purpose and Design: A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dose and Multiple Ascending Doses of TJ003234 in Rheumatoid Arthritis Patients.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Masking Description

Double-blind

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Subjects must be ≥ 18 and ≤70 years old when signing the informed consent, with no limitation of gender.
  • •Established Rheumatoid arthritis patients, diagnosed by ACR/EULAR criteria 2010 at least 6 months prior to randomisation.
  • •Single Ascending Dose: DAS28 score≤3.
  • •Multiple Ascending Dose: DAS28 score≤5.1 and >3.
  • •Allowed one or more standard treatments, but the start date should no later than 12 weeks(84 days) before the randomisation and should take at a stable dose more than 4 weeks(28 days) before the randomisation. The combination taken of Methotrexate (MTX) and leflunomide was not allowed within 4 weeks (28 days) before randomization.
  • •Subjects must agree to attendance the study and signed the inform concent by themselves.
  • •Subjects(include subjects's wife) are no pregnancy plan during the sceering and 3 months after complete the study and agree to use contraceptives that protocol suggest.

Exclusion Criteria

  • •Employees of the hospital or any other person that paticipant in the study and their immedidte family members.
  • •A documented history of an autoimmune disease other than RA (other than secondary Sjögren's syndrome) .
  • •Previous received Any biologic DMARD therapy including tsDMARD. •A positive hepatitis B (HBsAg, anti-HBc, and/or IgM anti-HBc), hepatitis C or HIV test at screening, indicative of a current or past infection.
  • •A history of active tuberculosis (TB) or positive serological test for TB (Quantiferon TB Gold or T-SPOT).
  • •Female patients who are pregnant during the study, or are breastfeeding. •Malignancy, or prior malignancy, with a disease free interval of <5 years after diagnosis and intervention except curative treatment for basal and squamous cell skin cancer.

Outcomes

Primary Outcomes

Number of subject with adverse events(AEs)

Time Frame: First dose up to last follow-up visit (i.e. 90 days after dosing for single dose part, 140 days after first dose for multiple dose part)

Number of subject with adverse events(AEs) to evaluate satety in patient with RA with vital signs, Electrocardiograms, physical examinations, laboratory tests and respiratory-related examinations

Secondary Outcomes

  • AUC from time 0 to the time of the last quantifiable concentration AUC0-tlast of TJ003234(Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part)
  • Maximum observed plasma concentration (Cmax) of TJ003234(Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part)
  • The proportion of subjects who produce the titers of anti-drug antibodies and neutralizing antibodies(Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part)
  • The proportion of subjects who produce anti-drug antibodies(Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part)
  • The proportion of subjects who produce neutralizing antibodies(Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (5)

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