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

NCT03971916 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-03-10

No results posted yet for this study

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

Interventions

DRUG

HBM9161(HL161BKN)

Subcutaneous injection; Single dose on Day 1

DRUG

Placebo

Subcutaneous injection; Single dose on Day 1

Sponsors & Collaborators

  • Harbour BioMed (Guangzhou) Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Desmond Yat Hin YAP · Queen Mary Hospital, Phase 1 Clinical Trials Centre

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-03
Primary Completion
2019-11-06
Completion
2019-11-06

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03971916 on ClinicalTrials.gov