A Trial Investigating the Pharmacodynamics of BC Combo THDB0207 Compared With Humalog® Mix25 and Simultaneous Injections of Humalog® and Lantus® in Healthy Chinese Volunteers

NCT05373186 | Completed Phase 1

• 1 other identifier: CT046-ADO05
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomised, double-blind, double-dummy, active-controlled, three-period crossover euglycemic clamp trial in healthy Chinese volunteers. Each subject will be randomly allocated to one of 6 treatment sequences. Each sequence comprises one single dose of BC Combo THDB0207, one single dose of Humalog® Mix25, or simultaneous administration of Humalog® and Lantus®. Subjects will come in a fasted state to the clinical trial centre in the morning of each dosing day and stay at the clinical trial centre until the 30-hour clamp procedures have been terminated.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• AUCGIR 0-2h

  Area under the glucose infusion rate curve until 2 hours after IMP dosing

  From t=0 to t=2 hours after IMP administration

Secondary Outcomes (19)

• AUCGIR 0-last

  From t=0 to t= 30 hours after IMP administration

• GIRmax

  From t=0 to t= 30 hours after IMP administration

• AUCGIR 0-1h

  From t=0 to t=1 hours after IMP administration

• AUCGIR 0-6h

  From t=0 to t=6 hours after IMP administration

• AUCGIR 0-24h

  From t=0 to t=24 hours after IMP administration

Study Arms (3)

BC Combo THDB0207

EXPERIMENTAL

Single administration of BC Combo THDB0207

Drug: Euglycemic clamp with BC Combo THDB0207

Humalog® Mix25

ACTIVE COMPARATOR

Single administration of Humalog® Mix25

Drug: Euglycemic clamp with Humalog® Mix25

Humalog® and Lantus®

ACTIVE COMPARATOR

Simultaneous administration of Humalog® and Lantus®

Drug: Euglycemic clamp with Humalog® and Lantus®

Interventions

Euglycemic clamp with BC Combo THDB0207 DRUG

Administration of a single dose of BC Combo THDB0207 during an euglycemic clamp procedure

BC Combo THDB0207

Euglycemic clamp with Humalog® Mix25 DRUG

Administration of a single dose of Humalog® Mix25 during an euglycemic clamp procedure

Humalog® Mix25

Euglycemic clamp with Humalog® and Lantus® DRUG

Simultaneous administration of Humalog® and Lantus® during an euglycemic clamp procedure

Humalog® and Lantus®

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects with Chinese origin. To qualify as a subject of Chinese origin (first-generation Chinese), the subject, the subject's biological parents, and all of the subject's biological grandparents are of exclusive Chinese descent and have been born in China.
• BMI between 18.5 and 30.0 kg/m2, both inclusive.
• Fasting plasma glucose concentration \<= 5.6 mmol/L (100 mg/dL).

You may not qualify if:

• Known or suspected hypersensitivity to IMP(s) or any of the excipients or to any component of the IMP formulation.
• Receipt of any investigational medicinal product within 3 months before randomisation in this trial.
• Women of childbearing potential who are not using a highly effective contraceptive method.
• Any history or presence of a life-threatening disease (i.e. cancer except basal cell skin cancer or squamous cell skin cancer), or of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic (including type 1 and type 2 diabetes mellitus, haematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynaecologic (if female), or infectious disease, or signs of acute illness as judged by the investigator.
• Heart rate at rest outside the range of 50-90 beats per minute.
• History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.

Sponsors & Collaborators

• Adocia: lead
• Tonghua Dongbao Pharmaceutical Co.,Ltd: collaborator

Study Sites (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

Location

MeSH Terms

Interventions

Glucose Clamp Technique; Insulin Lispro; Insulin Glargine

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Chemistry Techniques, Analytical; Investigative Techniques; Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Long-Acting

Study Officials

• Oliver Klein, MD

  Profil Institut für Stoffwechselforschung GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Three-period crossover

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 13, 2022
• Study Start: May 12, 2022
• Primary Completion: December 4, 2022
• Study Completion: December 4, 2022
• Last Updated: October 12, 2023

Record last verified: 2023-10

Locations

DE (1)