A First in Human (FIH) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DR10624

Last updated: February 1, 2025
Sponsor: Zhejiang Doer Biologics Co., Ltd.
Overall Status: Completed

Phase

1

Condition

Diabetes Mellitus, Type 2

Metabolic Syndrome

Diabetes Prevention

Treatment

Placebo

DR10624 for injection

Clinical Study ID

NCT05378893
DR10624-101
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

DR10624 is an Fc fusion protein tri-agonist with balanced glucagon-like peptide-1 receptor (GLP-1R)/glucagon receptor (GCGR)/ fibroblast growth factor 21 receptor (FGF21R) agonizing activities. The objectives of the planned clinical investigation will be to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single- and multiple-ascending doses of DR10624 via subcutaneous (SubQ) injection in a randomized, placebo-controlled, double-blind study.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. The subject is considered by the investigator to be in good general health asdetermined by medical history, clinical laboratory test results, vital signmeasurements, 12-lead ECG results, and physical examination findings at screening.

  2. Female subjects (heterosexually active, of childbearing potential, not pregnant, nottrying to become pregnant, and not lactating) are eligible to participate if theyagree to total abstinence from heterosexual intercourse or use a highly effectivemethod of birth control listed below, from screening through until at least 30 daysafter the last dose of the study drug. Male subjects with female partners of childbearing potential are eligible toparticipate if they are vasectomized, or agree to total abstinence from heterosexualintercourse, from screening through until at least 30 days after the last studydose, or use of an effective method of birth control listed above, from screeningthrough until at least 30 days after the last study dose. Male subjects must refrainfrom sperm donation throughout the study and for 30 days after the last study dose.

  3. The subject agrees to comply with all protocol requirements.

  4. The subject is able to provide written informed consent.

Additional inclusion criteria for Part 1:

  1. The subject is male or female 18 to 55 years of age, inclusive.

  2. The subject has a body weight ≥50 kg at screening and a BMI of 18 to 32 kg/m2,inclusive, or.

  3. The subject has a BMI of 30 to 40 kg/m2, inclusive, at screening in obesity subjectscohort.

Additional inclusion criteria for Part 2:

  1. The subject is male or female 18 to 60 years of age, inclusive.

  2. The subject has a BMI of 30 to 45 kg/m2 at screening, inclusive.

  3. Fasting triglyceride ≥150 mg/dL (1.7 mmol/L), and <500 mg/dL (5.7 mmol/L), atscreening.

Exclusion

Exclusion Criteria:

  1. The subject has a positive test result for hepatitis B surface antigen, hepatitis Cvirus antibody, or human immunodeficiency virus types 1 or 2 antibodies atscreening.

  2. The subject has a personal or family history of medullary thyroid cancer, ormultiple endocrine neoplasia syndrome Type 2, or a screening calcitonin ≥50 ng/L.

  3. The subject has a history of chronic pancreatitis or episode of acute pancreatitiswithin 3 months of screening.

  4. In Part 1, the subject has used any prescription medications (excluding oralcontraceptives, paracetamol, and ibuprofen) within 14 days before the first dose ofstudy drug. In Part 2, the subjects have been on stable lipid-lowering therapy <8weeks before the first dose of study drug.

  5. The subject has consumed alcohol within 48 hours before dosing or during theconfinement period.

  6. The subject is a smoker or has used tobacco, nicotine, or nicotine-containingproducts.

  7. The subject has a history of alcohol abuse or drug addiction within the last year orexcessive alcohol consumption.

  8. The subject has a positive test result for drugs of abuse and/or alcohol abuse atscreening and check-in for the first inpatient period.

  9. The subject is involved in strenuous activity or contact sports within 48 hoursbefore admission.

  10. The subject has donated blood or blood products >450 mL within 30 days before thefirst dose of study drug.

  11. The subject has total cholesterol >10.3 mmol/L or triglycerides ≥5.7 mmol/L (500mg/dL) at screening.

  12. The subject has clinically significant history or presence of ECG findings asdetermined by the investigator at screening and check-in,

  • Uncontrolled hypertension (defined as systolic blood pressure (SBP) ≥160 mmHg,and/or diastolic blood pressure (DBP) ≥100 mmHg), angina, bradycardia (ifassessed as clinically significant by the investigator), or severe peripheralarterial circulatory disorders.
  1. The subject has a history of relevant drug and/or food allergies (ie, allergy toDR10624 or excipients, or any significant food allergy that could preclude astandard diet in the clinical unit).

  2. The subject has a history of severe allergic or anaphylactic reactions.

  3. The subject has experienced a >5% loss in body weight within 2 months prior toscreening.

  4. Female subjects who are pregnant or lactating.

  5. The subject has a positive test for severe acute respiratory syndrome corona virus 2 (SARS-CoV-2). A positive rapid antigen test (RAT), isothermal nucleic acidamplification, or polymerase chain reaction (PCR) coronavirus disease-2019 (COVID-19) test during screening or at admission is acceptable provided the subjecthas a known previous COVID-19 infection ≥3 weeks prior to dosing, has recovered, andis now asymptomatic

  6. The subject has received study drug in another investigational study within 30 daysof dosing.

  7. In the opinion of the investigator, the subject is not suitable for entry into thestudy.

Additional exclusion criteria for subjects in Part 2:

  1. Subjects with coagulopathies.

  2. Poorly controlled diabetes, defined as HbA1c >8.5% at screening.

  3. The subject has been treated with the following anti-diabetic agents, glucagon-likepeptide-1 receptor agonist (GLP-1Ra), dipeptidyl peptidase-4 inhibitors (DPP-4i), orinsulin, within 30 days prior to screening until the follow-up visit.

  4. The subjects have >2 × upper limit of normal (ULN) of either alanineaminotransferase (ALT) or aspartate aminotransferase (AST), or >1.5 × ULN forbilirubin or alkaline phosphatase at screening.

  5. Subjects with contraindications to MRI.

Study Design

Total Participants: 153
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
June 22, 2022
Estimated Completion Date:
January 31, 2025

Study Description

This study includes 2 parts( 1 and 2). Part 1 involves a single dose of DR10624 taken as a subcutaneous injection just under the skin. Part 2 involve multiple doses of DR10624 taken as a subcutaneous injection (SC) just under the skin. Each participant will enroll in only one part.

Connect with a study center

  • New Zealand Clinical Research

    Christchurch, Canterbury 8011
    New Zealand

    Site Not Available

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