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

A Randomized, Double-Blind, Placebo-Controlled, Multiple-dose Escalation Phase I Study of Genakumab for Injection in Chinese Healthy Adults

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05894148

Enrollment

Registered

2023-06-08

Start date

2023-03-06

Completion date

2023-11-30

Last updated

2025-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interstitial Lung Disease

Keywords

Safety,, Tolerability,, Pharmacokinetics,, Genakumab

Brief summary

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

Detailed description

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.

Interventions

DRUGGenakumab injection

Group 1: 120mg Q4W，group 2: 200mg Q4W

DRUGplacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
The frequency of adverse events (AE)	Up to 20 weeks	adverse events during the study are to assess the safety of Genakumab.

Secondary

Measure	Time frame	Description
Maximum observed serum Genakumab concentration	up to 20 weeks	This is to assess pharma co kinetics of Genakumab.
Area under the serum Genakumab concentration-time curve	up to 20 weeks	This is to assess pharma co kinetics of Genakumab.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026