NCT07040930

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 rheumatoid-arthritis

Timeline
5mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Aug 2025Sep 2026

First Submitted

Initial submission to the registry

June 10, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 27, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2026

Last Updated

August 6, 2025

Status Verified

June 1, 2025

Enrollment Period

11 months

First QC Date

June 10, 2025

Last Update Submit

August 5, 2025

Conditions

Rheumatoid Arthritis

Keywords

phase Ibhealthy adultmultiple subcutaneous injectionsGenSci120

Outcome Measures

Primary Outcomes (3)

  • TEAEs

    Incidence and severity of treatment-emergent adverse events

    169 days

  • SAEs

    Incidence and severity of serious adverse events

    169 days

  • CSfadf

    Clinically significant changes from baseline

    169 days

Secondary Outcomes (11)

  • plasma

    169 days

  • AUC0-t, AUC0-∞

    169 days

  • Tmax

    169 days

  • Cmax

    169 days

  • t1/2

    half-life

  • +6 more secondary outcomes

Study Arms (2)

GenSci120

EXPERIMENTAL

Multiple ascending doses of GenSci120 administered subcutaneously (SC).

Drug: GenSci120

Placebo

EXPERIMENTAL

Multiple ascending doses of placebo administered subcutaneously (SC).

Drug: Placebo

Interventions

GenSci120DRUG

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

GenSci120
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Jing Zhang, M.D.

    Huashan Hospital

    PRINCIPAL INVESTIGATOR

  • Xiaojie Wu, M.D.

    Huashan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yiting Chi, Master

CONTACT

+86 13482779422chiyiting@genscigroup.com

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

June 10, 2025

First Posted

June 27, 2025

Study Start

August 1, 2025

Primary Completion (Estimated)

July 5, 2026

Study Completion (Estimated)

September 20, 2026

Last Updated

August 6, 2025

Record last verified: 2025-06

Locations

CN(1)