CompletedPhase 1

A Trial of HBM9378 in Healthy Chinese Subjects

China50 participantsStarted 2022-09-23

Plain-language summary

The objective is to evaluate the safety, tolerability and pharmacokinetic profile of a single subcutaneous injection of HBM9378 (SKB378) at different doses in healthy Chinese subjects.

Who can participate

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Written informed consent must be obtained.
✓. Healthy Chinese male and female subjects aged 18 to 50 years (both included) are enrolled, no clinically significant abnormalities.
✓. Total body weight ≥45kg at screening, and body mass index(BMI)between 18 and 28 kg/m2 (inclusive).
✓. Female subjects must meet one of the following criteria for participation in this study: Of non-childbearing potential ;
✓. Male subjects and female subjects of childbearing potential must use an effective contraceptive method during their participation in this clinical study.
✓. Can communicate successfully with the investigator and understand and comply with the requirements of this study.

Exclusion criteria

✕. History of relevant allergy/hypersensitivity.
✕. History of any of the following diseases:
✕. Any clinically significant comorbidity, as judged by the investigator.
✕. Clinical signs of active infection found at screening.
✕. Previous malignancy within the past 5 years.
✕. Acute or chronic bronchospastic disease within the past 3 years.
✕. Subject who are currently suffering from any medical condition.
✕. Subjects who have undergone organ transplantation.

What they're measuring

Adverse events

Timeframe: Strat of Treatment to end of study (approsimately 160days)

Pharmacokinetics-AUC0-last

Timeframe: Strat of Treatment to end of study (approsimately 160days)

Pharmacokinetics-Tmax

Timeframe: Strat of Treatment to end of study (approsimately 160days)

Pharmacokinetics-Cmax

Timeframe: Strat of Treatment to end of study (approsimately 160days)

Pharmacokinetics-CL/F

Timeframe: Strat of Treatment to end of study (approsimately 160days)

Pharmacokinetics-Vd/F

Timeframe: Strat of Treatment to end of study (approsimately 160days)

Pharmacokinetics-T1/2

Timeframe: Strat of Treatment to end of study (approsimately 160days)

Trial details

NCT IDNCT05790694

SponsorHarbour BioMed (Guangzhou) Co. Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-10-24

View on ClinicalTrials.gov More Asthma trials

Who can participate

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Written informed consent must be obtained.
✓. Healthy Chinese male and female subjects aged 18 to 50 years (both included) are enrolled, no clinically significant abnormalities.
✓. Total body weight ≥45kg at screening, and body mass index(BMI)between 18 and 28 kg/m2 (inclusive).
✓. Female subjects must meet one of the following criteria for participation in this study: Of non-childbearing potential ;
✓. Male subjects and female subjects of childbearing potential must use an effective contraceptive method during their participation in this clinical study.
✓. Can communicate successfully with the investigator and understand and comply with the requirements of this study.

Exclusion criteria

✕. History of relevant allergy/hypersensitivity.
✕. History of any of the following diseases:
✕. Any clinically significant comorbidity, as judged by the investigator.
✕. Clinical signs of active infection found at screening.
✕. Previous malignancy within the past 5 years.
✕. Acute or chronic bronchospastic disease within the past 3 years.
✕. Subject who are currently suffering from any medical condition.
✕. Subjects who have undergone organ transplantation.

What they're measuring

Adverse events

Timeframe: Strat of Treatment to end of study (approsimately 160days)

Pharmacokinetics-AUC0-last

Timeframe: Strat of Treatment to end of study (approsimately 160days)

Pharmacokinetics-Tmax

Timeframe: Strat of Treatment to end of study (approsimately 160days)

Pharmacokinetics-Cmax

Timeframe: Strat of Treatment to end of study (approsimately 160days)

Pharmacokinetics-CL/F

Timeframe: Strat of Treatment to end of study (approsimately 160days)

Pharmacokinetics-Vd/F

Timeframe: Strat of Treatment to end of study (approsimately 160days)

Pharmacokinetics-T1/2

Timeframe: Strat of Treatment to end of study (approsimately 160days)