Clinical trial

A Phase I/IIa Clinical Study to Assess the Single and Multiple Ascending Doses of MDR-001 Tablets in Healthy Participants and Obese/ Overweight Participants

Recruiting now · Phase 1, Phase 2 · 1 countries · Registry ID NCT06778850

Recruiting nowPhase 1, Phase 2Interventional

What this study is about

To investigate the safety and tolerability after single and multiple ascending doses of MDR-001 Tablets administered orally in healthy participants and obese/ overweight participants.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 55 Years
SexAll
Healthy volunteersAccepted
ConditionOverweight and Obese Volunteers

Full registry criteria

Inclusion Criteria: * Participants who are aged ≥ 18 and ≤ 55 years at the time of signing the informed consent; no gender restriction. * Participants with 27 ≤ body mass index (BMI) ≤ 45 kg/m2. * For male participants, a waist circumference ≥ 90 cm is required, while female participants ≥ 85 cm. Exclusion Criteria: * Participants with any condition that increases the risk of bleeding, such as hemorrhoids, acute gastritis, or gastric and duodenal ulcers. * Participants with personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia 2 (MEN2), or those with hereditary diseases that easily induce to medullary thyroid carcinoma. * Participants with a history of pancreatitis or symptomatic gallbladder disease. * Serum calcitonin \> ULN at screening. * Participants with systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg at screening. * Participants with ALT \>2 × ULN and /or AST \> 2 × ULN at screening. * Participants whose fasting triglycerides \> 5.7 mmol/L, total cholesterol \> 7.75 mmol/L, low-density lipoprotein cholesterol \> 4.9 mmol/L at screening. * Participants with abnormal uric acid levels accompanied by clinical symptoms (those without clinical symptoms can be included). * Participants with fasting blood glucose levels \> 7 mmol/L. * Participants with creatinine clearance \< 60 mL/min at screening \[calculation formula: CLcr: (140 - age) × weight (kg) / \[72 × 0.0113 × Scr (μmol/L)\], × 0.85 for females\]. * Participants have experienced significant changes in diet or exercise habits or within ≥5% changes in body weight within 3 months prior to screening. * Participants with clinically significant ECG abnormality deemed unsuitable participation for study by the investigator; or with ECG QTcF values \> 450 ms for male participants or \> 470 ms for female participants.

Treatments and study arms

MDR-001

Drug

Oral administration of small molecule MDR-001 tablets

palcebo

Drug

Administered orally placebo

Primary outcomes

Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug AdministrationBaseline through Day 84

A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Study locations

1 locations were listed when this page was built. The first 40 are shown.

The first hospital of Jilin University🇨🇳 Changchun, Jilin, China
Yanhua DingContact
Guixia WangContact