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A Single- and Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of THDBH120 Injection in Healthy Subjects

NCT06744868 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2024-12-27

No results posted yet for this study

Summary

This study includes single-ascending dose cohorts (SAD cohorts) and multiple-ascending dose cohorts (MAD cohorts). The aim of this trial is to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of THDBH120 injection in healthy patients.

Conditions

  • Healthy

Interventions

DRUG

THDBH120 injection (SAD)

Participants received escalating single doses of THDBH120 by subcutaneous injection.

DRUG

Placebo of THDBH120 injection (SAD)

Participants received single dose of placebo by subcutaneous injection.

DRUG

THDBH120 injection (MAD)

Participants received multiple doses of THDBH120 once weekly for four weeks by subcutaneous injection.

DRUG

Placebo of THDBH120 injection (MAD)

Participants received placebo once weekly for four weeks by subcutaneous injection.

Sponsors & Collaborators

  • Tonghua Dongbao Pharmaceutical Co.,Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-12-19
Primary Completion
2024-09-22
Completion
2024-09-22

Countries

  • China

Study Locations

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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 NCT06744868 on ClinicalTrials.gov