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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-55
SponsorMindRank AI Ltd

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • MDR-001
  • palcebo

Treatment groups

131 Participants
are divided into 4 treatment groups

Sponsors and collaborators