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Recruiting NCT07040930

Assessment of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Injections of GenSci120 in Healthy Adult Participants in China.

Phase I Interventional Rheumatoid Arthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GenSci120, Placebo.
Who it may be relevant to
Registry conditions: Rheumatoid Arthritis. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Injections of GenSci120 in Healthy Adult Participants in China

Overview

This study is designed to evaluate the safety, tolerability, PK and PD of multiple subcutaneous injections of GenSci120 in a randomized, double-blind, placebo-controlled, multiple-ascending-dose phase Ib trial involving healthy adult participants.

Interventions

  • Drug GenSci120
    a total of 3 doses of the investigational medicinal product (IMP) SC every four weeks (Q4W) at the planned dose level
  • Drug Placebo
    a total of 3 doses of the investigational medicinal product (IMP) SC every four weeks (Q4W) at the planned dose level

Primary outcome measures

  • TEAEs [Time frame: 169 days]
  • SAEs [Time frame: 169 days]
  • CSfadf [Time frame: 169 days]
Secondary outcome measures (11)
  • plasma [Time frame: 169 days]
  • AUC0-t, AUC0-∞ [Time frame: 169 days]
  • Tmax [Time frame: 169 days]
  • Cmax [Time frame: 169 days]
  • t1/2 [Time frame: half-life]
  • CL/F [Time frame: apparent clearance]
  • V/F [Time frame: 169 days]
  • RO of T cell subset [Time frame: 169 days]
  • cell counts of T cell subset [Time frame: 169 days]
  • Incidence of ADA [Time frame: 169 days]
  • Time of ADA [Time frame: 169 days]

Eligibility criteria

Inclusion criteria

  • Ages 18-55; ≥3 per gender for each cohort.
  • BMI: 18-30; Weight: ≥50 kg (male), ≥45 kg (female).
  • No clinically significant abnormalities in medical history, physical exam, vital signs, or lab/ECG/pulmonary imaging.
  • Men/WOCBP must use effective contraception throughout study; no plans to conceive; WOCBP must have negative pregnancy test and not breastfeeding. Women of non-childbearing potential: post-hysterectomy/salpingectomy or postmenopausal (FSH >40 IU/L).
  • Able to provide informed consent; willing to comply with all study requirements

Exclusion criteria

  • Allergy to GenSci120 or severe allergies.
  • Injection site issues affecting evaluation.
  • Significant medical conditions impacting study outcome.
  • History of malignant tumors, including listed cancers.
  • Seizure history, head injury causing unconsciousness.
  • Psychiatric disorders impairing daily activities or cognitive issues.
  • Severe immunodeficiency (e.g., HIV).
  • Recent trauma, surgery, or GI issues affecting absorption.
  • Recent severe infections or antimicrobial treatments.
  • Live vaccines within a month prior to screening.
  • Abnormal vital signs/ECG: BP extremes, QTcF >450ms.
  • Positive for hepatitis B/C, HIV, syphilis during screening.
  • Positive TB test via IGRA.
  • Recent use of immunosuppressive or targeted therapies.
  • Medication use within 14 days prior to randomization.
  • Participation in other clinical trials recently/currently.
  • Excessive alcohol consumption (over six months).
  • Heavy smoking, unwillingness to quit, positive nicotine tests.
  • Positive drug screen for specific substances.
  • Recent soft/hard drug use within specified periods.
  • Blood donation/product receipt recently or poor venous access.
  • Study staff involved in the trial.
  • Other conditions deemed unsuitable by investigators.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Huashan Hospital Affiliated to Fudan University — Shanghai

Identifiers

NCT: NCT07040930 · GenSci120-103

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗