A First in Human (FIH) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmaco… (NCT05378893) | Clinical Trial Compass
CompletedPhase 1
A First in Human (FIH) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DR10624
New Zealand153 participantsStarted 2022-06-22
Plain-language 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.
Who can participate
Age range18 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. The subject is considered by the investigator to be in good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead ECG results, and physical examination findings at screening.
✓. Female subjects (heterosexually active, of childbearing potential, not pregnant, not trying to become pregnant, and not lactating) are eligible to participate if they agree to total abstinence from heterosexual intercourse or use a highly effective method of birth control listed below, from screening through until at least 30 days after the last dose of the study drug.
✓. The subject agrees to comply with all protocol requirements.
✓. The subject is able to provide written informed consent.
✓. The subject is male or female 18 to 55 years of age, inclusive.
✓. The subject has a body weight ≥50 kg at screening and a BMI of 18 to 32 kg/m2, inclusive, or.
✓. The subject has a BMI of 30 to 40 kg/m2, inclusive, at screening in obesity subjects cohort.
✓. The subject is male or female 18 to 60 years of age, inclusive.
Exclusion criteria
✕. The subject has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus types 1 or 2 antibodies at screening.
✕. The subject has a personal or family history of medullary thyroid cancer, or multiple endocrine neoplasia syndrome Type 2, or a screening calcitonin ≥50 ng/L.
What they're measuring
1
Number of participants with one or more treatment-emergent adverse event (TEAE), serious adverse event (SAE) and adverse event of special interest (AESI).
Timeframe: baseline through day 29(part 1)or day 106(part 2)
✕. The subject has a history of chronic pancreatitis or episode of acute pancreatitis within 3 months of screening.
✕. In Part 1, the subject has used any prescription medications (excluding oral contraceptives, paracetamol, and ibuprofen) within 14 days before the first dose of study drug. In Part 2, the subjects have been on stable lipid-lowering therapy \<8 weeks before the first dose of study drug.
✕. The subject has consumed alcohol within 48 hours before dosing or during the confinement period.
✕. The subject is a smoker or has used tobacco, nicotine, or nicotine-containing products.
✕. The subject has a history of alcohol abuse or drug addiction within the last year or excessive alcohol consumption.
✕. The subject has a positive test result for drugs of abuse and/or alcohol abuse at screening and check-in for the first inpatient period.