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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

NCT ID: NCT06744868

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-19

Study Completion Date

2024-09-22

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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THDBH120 injection (SAD)

Group Type EXPERIMENTAL

THDBH120 injection (SAD)

Intervention Type DRUG

Participants received escalating single doses of THDBH120 by subcutaneous injection.

Placebo of THDBH120 injection (SAD)

Group Type PLACEBO_COMPARATOR

Placebo of THDBH120 injection (SAD)

Intervention Type DRUG

Participants received single dose of placebo by subcutaneous injection.

THDBH120 injection (MAD)

Group Type EXPERIMENTAL

THDBH120 injection (MAD)

Intervention Type DRUG

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

Placebo of THDBH120 injection (MAD)

Group Type PLACEBO_COMPARATOR

Placebo of THDBH120 injection (MAD)

Intervention Type DRUG

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

Interventions

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THDBH120 injection (SAD)

Participants received escalating single doses of THDBH120 by subcutaneous injection.

Intervention Type DRUG

Placebo of THDBH120 injection (SAD)

Participants received single dose of placebo by subcutaneous injection.

Intervention Type DRUG

THDBH120 injection (MAD)

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

Intervention Type DRUG

Placebo of THDBH120 injection (MAD)

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy Chinese subjects aged 18 to 45 years (inclusive), male or female;
* Body Mass Index (BMI) ≥ 19 kg/m2 and ≤ 28kg/m2, male weight ≥ 50 kg, females weight≥ 45 kg;
* Normal or abnormal but not clinically significant physical examination and vital signs at screening.

Exclusion Criteria

* Have a diagnosis of type 2 diabetes or have had episode of severe hypoglycemia;
* Pulse rate is less than 50 bpm or more than 100 bpm at screening;
* 12-lead electrocardiogram with prolonged QTcF (male \>450 ms, female \>470 ms) or PR\>200ms. Or any other situation in which a 12-lead ECG suggests a risk of ineligibility at screening;
* A history of pancreatitis (including chronic pancreatitis or idiopathic acute pancreatitis), abnormal amylase and lipase with clinical significance or gastrointestinal injury (e.g., chronic gastritis, peptic ulcer, recurrent gastroesophageal reflux disease, cholecystitis, and gallstones) or any gastrointestinal disease that interferes with gastric emptying (e.g., gastric bypass surgery, pyloric stenosis);
* Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2;
* Use of SGLT inhibitors, DPP4 inhibitors, GLP-1 analogs, GLP-1 receptor agonists, and other drugs that investigators recognize may affect the study during the 3 months prior to randomization;
* Have had a significant change in weight during the 6 months prior to screening, such as weight loss \> 10%, or recent significant changes in diet or exercise habits.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tonghua Dongbao Pharmaceutical Co.,Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking University First Hospital

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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THDBH120L101

Identifier Type: -

Identifier Source: org_study_id