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

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

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2026-09-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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GenSci120

Multiple ascending doses of GenSci120 administered subcutaneously (SC).

Group Type EXPERIMENTAL

GenSci120

Intervention Type DRUG

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

Placebo

Multiple ascending doses of placebo administered subcutaneously (SC).

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

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

Interventions

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GenSci120

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Ages 18-55; ≥3 per gender for each cohort.
2. BMI: 18-30; Weight: ≥50 kg (male), ≥45 kg (female).
3. No clinically significant abnormalities in medical history, physical exam, vital signs, or lab/ECG/pulmonary imaging.
4. 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).
5. Able to provide informed consent; willing to comply with all study requirements

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes