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

NCT03971916 | Completed Phase 1

• 1 other identifier: 9161.1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Chinese Volunteers

Outcome Measures

Primary Outcomes (1)

• The number [N (%)] of subjects with drug-related AEs

  The number \[N (%)\] of subjects with drug-related AEs

  85 days

Study Arms (4)

HBM9161 340mg

EXPERIMENTAL

Drug: HBM9161(HL161BKN)

HBM9161 510mg

EXPERIMENTAL

Drug: HBM9161(HL161BKN)

HBM9161 680mg

EXPERIMENTAL

Drug: HBM9161(HL161BKN)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

HBM9161(HL161BKN) DRUG

Subcutaneous injection; Single dose on Day 1

HBM9161 340mg; HBM9161 510mg; HBM9161 680mg

Placebo DRUG

Subcutaneous injection; Single dose on Day 1

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Han Chinese male or female subjects, and his/her biological parents and grandparents are of Han Chinese ethnicity.
• Body weight ≥ 50kg with BMI ≥19.0 and \<=24.0 kg/m2 at screening and baseline visit.
• Generally, in good health with no clinically significant abnormalities as determined by medical history, physical examination, 12-lead ECG and clinical laboratory tests.

You may not qualify if:

• Subject has a total IgG level of \< 700mg/dL at screening.
• 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).
• History of relevant allergy/hypersensitivity (including allergy to study drug or its excipients).
• Any laboratory values outside the reference range that are of clinical significance according to investigator's clinical judgement.
• Subject has estimated creatinine clearance ≤ 80 mL/min calculated by Cockcroft Gault formula at screening.
• Subject has any ECG abnormality defined in the protocol (a single repeat will be allowed for eligibility determination) at screening or Day -1:
• Positive HIV test result at screening.
• Positive testing for HBs Antigen and/or a positive Hepatitis C antibody test result at screening.
• Subject has a positive T-cell interferon-γ release assay (TIGRA) result
• 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.
• 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.
• Lactating female subjects.

Sponsors & Collaborators

• Harbour BioMed (Guangzhou) Co. Ltd.: lead

Study Sites (1)

Queen Mary Hospital, Phase 1 Clinical Trials Centre

Hong Kong, China

Location

Study Officials

• Desmond Yat Hin YAP

  Queen Mary Hospital, Phase 1 Clinical Trials Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: June 3, 2019
• Study Start: June 3, 2019
• Primary Completion: November 6, 2019
• Study Completion: November 6, 2019
• Last Updated: March 10, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)