Phase I Drug-Drug Interaction Study of UBT251 Injection in Participants With Overweight or Obesity
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorThe United Bio-Technology (Hengqin) Co., Ltd.
About this trial
This is a Phase I, open-label, two-cohort study designed to evaluate the drug-drug interaction potential of multiple-dose UBT251 Injection in adult participants with overweight or obesity.
The primary objective of Cohort 1 is to evaluate the effect of UBT251 Injection on the pharmacokinetic (PK) profiles of metformin and warfarin. The secondary objectives of Cohort 1 are to assess the influence of UBT251 Injection on the pharmacodynamic (PD) characteristics of warfarin, to evaluate the safety of UBT251 Injection administered alone, as well as metformin and warfarin administered alone or in combination with UBT251 Injection, and to characterize the PK, PD, and immunogenicity profiles following repeated UBT251 Injection dosing.
The primary objective of Cohort 2 is to evaluate the effect of UBT251 Injection on the PK profiles of atorvastatin and digoxin. The secondary objectives of Cohort 2 are to evaluate the safety of UBT251 Injection alone, atorvastatin and digoxin alone, and their combination with UBT251 Injection, as well as to assess the PK, PD, and immunogenicity characteristics after multiple administrations of UBT251 Injection.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants with overweight or obesity, aged 18-45 years inclusive; Cohort 1 includes male participants only, and Cohort 2 includes both male and female participants.
Body weight ≥50.0 kg, body mass index (BMI) ranging from 24.0 to 35.0 kg/m² inclusive (BMI = weight(kg)/height²(m²)).
Participants (including their partners) have no plan to conceive from screening through 6 months after study completion, are willing to adopt contraceptive measures specified in the study, and have no plan to donate sperm or ova within 6 months after trial completion.
Participants are able to communicate well with investigators, have fully understood this study, voluntarily participate in it, understand and comply with all study requirements, and provide written informed consent.
Disqualifiers
Known hypersensitivity or intolerance to investigational product or its excipients, or hypersensitivity to other GLP-1, GIP, GCG receptor agonists; or prior history of multiple or severe clinically significant drug hypersensitivity reactions; or active allergic disease or high-sensitivity constitution;
Personal or family history (first-degree relatives: parents, children or siblings) of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2);
History of malignancy within 5 years prior to screening, except for adequately treated carcinoma in situ of the cervix, basal-cell or squamous-cell skin cancer, radically resected local prostate cancer, and radically resected ductal carcinoma in situ of the breast;
History of acute or chronic pancreatitis, pancreatic injury, or pancreatic surgery;
Trial design
Design model
Single group
Treatments tested in this trial
UBT251
DrugSubcutaneous injection administered once weekly with dose escalation
Metformin hydrochloride
DrugOral administration. Metformin hydrochloride will be given as twice-daily doses for 7 consecutive administrations.
Warfarin Sodium
DrugOral administration. Warfarin sodium will be given as 2 single doses.
Atorvastatin calcium
DrugOral administration. Atorvastatin calcium will be given as 2 single doses.
Digoxin
DrugOral administration. Digoxin will be given as 2 single doses.
Treatment groups
48 Participants
are divided into 1 treatment groupGroup A: UBT251Experimental treatment 5 interventions
Trial outcomes
Primary outcomes
1
Area under plasma concentration-time curve of metformin (AUC0-τ) and S-warfarin, R-warfarin (AUC0-t, AUC0-∞)
Compare AUC0-τ of metformin after multiple-dose administration alone, and AUC0-t and AUC0-∞ of S-warfarin and R-warfarin after single-dose administration alone, with the corresponding parameters when these drugs are administered following dose-escalated and continued 6.0 mg UBT251 in Cohort 1.
Time frame
From time 0 to 30 hours (metformin, post last dose) and 168 hours (S-warfarin, R-warfarin) after respective doses2
Area under plasma concentration-time curve (AUC0-t and AUC0-∞) of atorvastatin and digoxin
Compare AUC0-t and AUC0-∞ of single-dose atorvastatin and single-dose digoxin administered alone, with corresponding parameters when administered following dose-escalated and continued 6.0 mg UBT251 in Cohort 2.
Time frame
From time 0 to 72 hours (atorvastatin) and 120 hours (digoxin) after respective single dosesSecondary outcomes
1
Peak Plasma Concentration (Cmax) of metformin in Cohort 1
Peak plasma concentration (Cmax) of metformin at steady-state in Cohort 1
Time frame
Up to 30 hours following last dose at steady-state2
Time to Peak Plasma Concentration (Tmax) of metformin in Cohort 1
Time to reach peak plasma concentration (Tmax) of metformin at steady-state in Cohort 1
Time frame
Up to 30 hours following last dose at steady-state3
Area under the plasma concentration-time curve from 0 to last measurable time point (AUC0-t) of metformin in Cohort 1
Area under the plasma concentration-time curve from time 0 to last quantifiable concentration (AUC0-t) of metformin at steady-state in Cohort 1
Time frame
Pre-dose and up to 30 hours following last dose at steady-state4
Area under the plasma concentration-time curve from 0 to infinity (AUC0-∞) of metformin in Cohort 1
Area under the plasma concentration-time curve extrapolated to infinity (AUC0-∞) of metformin at steady-state in Cohort 1
Time frame
Pre-dose and up to 30 hours following last dose at steady-stateSponsors and contacts
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Source ClinicalTrials.gov