NCT06778850
Recruiting
Phase 1
A Randomized, Double-blind, Placebo-controlled Phase I/IIa Clinical Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of MDR-001 Tablets Administrated Orally in Healthy Participants and Obese/ Overweight Participants
MindRank AI Ltd1 site in 1 country131 target enrollmentStarted: June 9, 2023Last updated:
Overview
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- MindRank AI Ltd
- Enrollment
- 131
- Locations
- 1
- Primary Endpoint
- 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 Administration
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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/m
- •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\].
Arms & Interventions
MDR-001（SAD）
Experimental
Single doses of MDR-001 administered orally.
Intervention: MDR-001 (Drug)
Placebo (SAD)
Experimental
Placebo administered orally.
Intervention: palcebo (Drug)
MDR-001 (MAD)
Experimental
Multiple doses of MDR-001 administered orally.
Intervention: MDR-001 (Drug)
Placebo (MAD)
Experimental
Placebo administered orally.
Intervention: palcebo (Drug)
Outcomes
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 Administration
Time Frame: Baseline 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
Secondary Outcomes
- PK: Area Under the Concentration Versus Time Curve (AUC) of MDR-001(Baseline through Day 84)
- Change from Baseline in Fasting Glucose(Baseline through Day 84)
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of MDR-001(Baseline through Day 84)
- Change from Baseline in Glycated Hemoglobin (HbA1c)(Baseline through Day 84)
- Change from Baseline in Body Weight(Baseline through Day 84)
Investigators
Study Sites (1)
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