A Phase I Study Evaluating the Safety, Tolerability, PK and PD in Healthy Chinese Volunteers

Healthy Chinese Volunteers Clinical Trial

Official title:

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of HBM9161(HL161BKN) in Healthy Chinese Volunteers (Randomized, Single-blinded, Placebo-controlled Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03971916
• Other study ID #: 9161.1
• Status: Completed
• Phase: Phase 1
• Start date: June 3, 2019
• Est. completion date: November 6, 2019

Study information

• Verified date: March 2021
• Source: Harbour BioMed (Guangzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Trial Objective: To investigate the safety, tolerability, PK, and PD following single ascending doses of HBM9161 in healthy Chinese subjects.

Description:

HBM9161(HL161BKN) is a human monoclonal antibody. HBM9161 targets the neonatal Fc receptor (FcRn) . The neonatal FcRn is a potential therapeutic target for many autoimmune diseases. This Phase I study will evaluate the safety, tolerability, PK, and PD of subcutaneous (SC) doses of HBM9161(HL161BKN) (abbreviated as HBM9161) in healthy Chinese subjects. Up to 24 healthy Chinese subjects will be randomized into the study. For each dose group, 8 subjects will be randomized (6 subjects to HBM9161 group and 2 subjects to placebo group).

This study will also provide guidance on doses to be used in future studies involving patients with autoimmune diseases.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 6, 2019
• Est. primary completion date: November 6, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Han Chinese male or female subjects, and his/her biological parents and grandparents are of Han Chinese ethnicity.

2. Body weight = 50kg with BMI =19.0 and <=24.0 kg/m2 at screening and baseline visit.

3. Generally, in good health with no clinically significant abnormalities as determined by medical history, physical examination, 12-lead ECG and clinical laboratory tests.

Exclusion Criteria:

1. Subject has a total IgG level of < 700mg/dL at screening.

2. Subject has an active infection or has had a serious infection within 6 weeks prior to Day -1 or infection requiring oral anti-infective agents within 2 weeks prior to Day-1, or subject had a febrile illness or symptomatic, viral, bacterial, or fungal infection within 1 week prior to admission (Day -1).

3. History of relevant allergy/hypersensitivity (including allergy to study drug or its excipients).

4. Any laboratory values outside the reference range that are of clinical significance according to investigator's clinical judgement.

5. Subject has estimated creatinine clearance = 80 mL/min calculated by Cockcroft Gault formula at screening.

6. Subject has any ECG abnormality defined in the protocol (a single repeat will be allowed for eligibility determination) at screening or Day -1:

7. Positive HIV test result at screening.

8. Positive testing for HBs Antigen and/or a positive Hepatitis C antibody test result at screening.

9. Subject has a positive T-cell interferon-? release assay (TIGRA) result

10. Subjects who had immunization within 4 weeks before screening; or subjects who plan to have immunization during the study and within 12 weeks after dosing of the study drug.

11. For female subjects, positive pregnancy test at screening or Day -1, or planning to become pregnant from screening until 90 days after the dosing of the study drug.

12. Lactating female subjects.

Related Conditions & MeSH terms

• Healthy Chinese Volunteers

Intervention

Drug:
• HBM9161(HL161BKN)
Subcutaneous injection; Single dose on Day 1
• Placebo
Subcutaneous injection; Single dose on Day 1

Locations

Country	Name	City	State
China	Queen Mary Hospital, Phase 1 Clinical Trials Centre	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Harbour BioMed (Guangzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number [N (%)] of subjects with drug-related AEs	The number [N (%)] of subjects with drug-related AEs	85 days