Clinical Study of Multiple Dose Genakumab for Injection in Chinese Healthy Adults

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-06

Study Completion Date

2023-11-30

Brief Summary

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To evaluate the safety and tolerability of multiple-dose subcutaneous injections of Genakumab for Injection in Chinese healthy adult volunteers.

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Detailed Description

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There are 2 dose groups with 12 participants in each group, including 10 participants in the experimental group and 2 participants in the placebo control group. Each subject receives Genakumab or placebo once every four weeks for three times.

Conditions

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Interstitial Lung Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Genakumab injection

Group 1: 120mg，group 2: 200mg

Group Type EXPERIMENTAL

Genakumab injection

Intervention Type DRUG

Group 1: 120mg Q4W，group 2: 200mg Q4W

placebo

The placebo contains other excipients except Genakumab, and its appearance is consistent with that of Genakumab for injection

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

The placebo contains other excipients except Genakumab, and its appearance is consistent with that of Genakumab for injection.

Interventions

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Genakumab injection

Group 1: 120mg Q4W，group 2: 200mg Q4W

Intervention Type DRUG

placebo

The placebo contains other excipients except Genakumab, and its appearance is consistent with that of Genakumab for injection.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18 years ≤ age ≤45 years, and in good health;
* body mass index is within the range of 19 - 26 kg/m\^2 (including 19 kg/m\^2 and 26 kg/m\^2);
* No parental scheme from the screening period to 3 months after the study period.

Exclusion Criteria

* Participants have abnormal physical and auxiliary examination results with clinical significance;
* History of cardiovascular, liver, kidney, digestive, blood, nervous system and allergic diseases, mental and metabolic disorders,
* Participants who use any prescription drugs within 2 weeks prior dosing.
* Participants who receive (attenuated) live vaccines within 3 months prior to dosing;
* Participation in any clinical investigation within 3 months prior to dosing;
* Donation or loss of 400 mL or more of blood within 3 months prior to dosing;
* Tuberculosis symptoms, contact with patients with suspected tuberculosis symptoms
* Positive results in Hepatitis B surface antigen (HBsAg), Hepatitis C antibody, Syphilis antibody or HIV antibody;
* Current or previous drug or alcohol abuse;
* Other conditions in which the investigator preclude enrollment into the study

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes