Clinical Study of Genakumab for Injection in Chinese Healthy Volunteers

NCT04337437 | Unknown Phase 1

• 1 other identifier: GenSci 048-I CT
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and tolerability of single subcutaneous injection of Genakumab for Injection in Chinese healthy adult volunteers

Conditions

Juvenile Idiopathic Arthritis

Outcome Measures

Primary Outcomes (3)

• Maximum observed serum Genakumab concentration

  Baseline, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 168h, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 113 after administration

• Area under the serum Genakumab concentration-time curve

  Baseline, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 168h, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 113 after administration

• Measurement of the serum IL-1β for pharmacodynamics study

  Baseline, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 168h, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 113 after administration

Secondary Outcomes (1)

• The frequency of adverse events (AE)

  From screening to follow-up period (up to day 22)

Study Arms (2)

Genakumab injection：5 groups

EXPERIMENTAL

150 mg/1ml/bottle, single subcutaneous injection. Group A : 0.3mg/kg, Group B : 1mg/kg, Group C : 2mg/kg, Group D：4mg/kg, Group E : 6mg/kg,

Drug: Genakumab

Placebo for this trial : 5 groups

PLACEBO COMPARATOR

The placebo contains other excipients except Genakumab, and its appearance is consistent with that of Genakumab for injection, 150 mg/1ml/bottle, single subcutaneous injection. Group A : 0.3mg/kg, Group B : 1mg/kg, Group C : 2mg/kg, Group D：4mg/kg, Group E : 6mg/kg,

Drug: Placebo for this trial

Interventions

Genakumab DRUG

150 mg/1ml/bottle, single subcutaneous injection.

Genakumab injection：5 groups

Placebo for this trial DRUG

The placebo contains other excipients except Genakumab, and its appearance is consistent with that of Genakumab for injection, 150 mg/1ml/bottle, single subcutaneous injection.

Placebo for this trial : 5 groups

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years ≤ age ≤50 years, and in good health;
• kg ≤ weight ≤100kg , and body mass index is within the range of 18 - 28 kg/m\^2 (including 18 kg/m\^2 and 28 kg/m\^2);
• No parental scheme from the screening period to 6 months after the study period.

You may not qualify if:

• 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, acute or chronic bronchospastic disease;
• Smoking more than 5 cigarettes per day;
• Participants who use any prescription drugs within 4 weeks prior dosing, or over-the-counter medication within 2 weeks prior to dosing. Participants who receive treatment of any biologics within three months prior to dosing. Participants who receive (attenuated) live vaccines within six 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; donation or loss of 200 mL or more of blood within 4 weeks prior to dosing; or donation of component blood within 2 weeks 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;
• Clinically significant acute infection within 2 weeks prior to dosing;
• Current or previous drug or alcohol abuse;
• Other conditions in which the investigator preclude enrollment into the study.

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead
• Peking Union Medical College Hospital: collaborator

Study Sites (1)

Clinical Pharmacology Research Center of Peking Union Medical College Hospital

Beijing, China

RECRUITING

Related Publications (1)

• Liu H, Yuan Y, Tian W, Luo T, Xu Q, Zhu X, Chen R. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Firsekibart, an Anti-interleukin-1beta Monoclonal Antibody, in Healthy Chinese Participants: A Randomized, Double-Blind, Placebo-Controlled Phase 1 Study. Adv Ther. 2025 Sep;42(9):4611-4625. doi: 10.1007/s12325-025-03279-4. Epub 2025 Jul 25.

  PMID: 40711661 DERIVED

MeSH Terms

Conditions

Arthritis, Juvenile

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Rui Chen

  Clinical Pharmacology Research Center of Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luocheng Xu

CONTACT

800-820-0469; xuluocheng@gensci-china.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind (participant, investigator), excluding one non-blind investigator doctor.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 7, 2020
• Study Start: April 22, 2019
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: April 7, 2020

Record last verified: 2020-03

Locations

CN (1)