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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05378893




Registration number
NCT05378893
Ethics application status
Date submitted
25/03/2022
Date registered
18/05/2022
Date last updated
18/11/2023

Titles & IDs
Public title
A First in Human (FIH) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DR10624
Scientific title
A Phase 1, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-and-Multiple-Ascending Subcutaneous Doses of DR10624
Secondary ID [1] 0 0
DR10624-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy, Obesity, Metabolically 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - DR10624 for injection
Treatment: Drugs - Placebo

Experimental: Single-ascending dose:Part1:DR10624 - Escalating doses of DR10624 for injection administered subcutaneously in healthy participants or obese but otherwise healthy participants

Placebo comparator: Single-ascending dose:Part1:placebo - Escalating doses of placebo for injection administered subcutaneously in in healthy participants or obese but otherwise healthy participants

Experimental: Multiple-ascending dose:Part2:DR10624 - Escalating doses of DR10624 for injection administered subcutaneously in obese adult subjects with moderate hypertriglyceridemia

Placebo comparator: Multiple-ascending dose:Part2:placebo - Escalating doses of placebo for injection administered subcutaneously in obese adult subjects with moderate hypertriglyceridemia


Treatment: Drugs: DR10624 for injection
administered via subcutaneous injection

Treatment: Drugs: Placebo
administered via subcutaneous injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with one or more treatment-emergent adverse event (TEAE), serious adverse event (SAE) and adverse event of special interest (AESI).
Timepoint [1] 0 0
baseline through day 29(part 1)or day 106(part 2)
Secondary outcome [1] 0 0
Area under the serum concentration versus time curve (AUC)
Timepoint [1] 0 0
baseline through day 29(part 1)or day 106(part 2)
Secondary outcome [2] 0 0
Maximum observed serum concentration (Cmax)
Timepoint [2] 0 0
baseline through day 29(part 1)or day 106(part 2)
Secondary outcome [3] 0 0
Time to reach maximum observed serum concentration (Tmax)
Timepoint [3] 0 0
baseline through day 29(part 1)or day 106(part 2)
Secondary outcome [4] 0 0
Terminal elimination half-life (t1/2)
Timepoint [4] 0 0
baseline through day 29(part 1)or day 106(part 2)
Secondary outcome [5] 0 0
Mean residence time (MRT)
Timepoint [5] 0 0
baseline through day 29(part 1)or day 106(part 2)
Secondary outcome [6] 0 0
Apparent clearance after extravascular administration (CL/F)
Timepoint [6] 0 0
baseline through day 29(part 1)or day 106(part 2)
Secondary outcome [7] 0 0
Apparent volume of distribution during the terminal elimination phase after extravascular administration (Vz/F)
Timepoint [7] 0 0
baseline through day 29(part 1)or day 106(part 2)
Secondary outcome [8] 0 0
AUC from time 0 to the time of the dosing interval (AUC0-t)
Timepoint [8] 0 0
baseline through day 106(part 2)
Secondary outcome [9] 0 0
Accumulation ratio (AR)
Timepoint [9] 0 0
baseline through day 106(part 2)
Secondary outcome [10] 0 0
Predose concentrations(Ctrough)
Timepoint [10] 0 0
baseline through day 106(part 2)
Secondary outcome [11] 0 0
change in body weight
Timepoint [11] 0 0
baseline through Day 85
Secondary outcome [12] 0 0
change in adiponectin
Timepoint [12] 0 0
baseline through Day 85
Secondary outcome [13] 0 0
change in BMI
Timepoint [13] 0 0
baseline through Day 85
Secondary outcome [14] 0 0
change in waist circumference
Timepoint [14] 0 0
baseline through Day 85
Secondary outcome [15] 0 0
change in fasting lipid profile
Timepoint [15] 0 0
baseline through Day 85
Secondary outcome [16] 0 0
change in fasting plasma glucose (FPG)
Timepoint [16] 0 0
baseline through Day 85
Secondary outcome [17] 0 0
change in HbA1c
Timepoint [17] 0 0
baseline through Day 85
Secondary outcome [18] 0 0
change in C-peptide
Timepoint [18] 0 0
baseline through Day 85
Secondary outcome [19] 0 0
change in fasting insulin
Timepoint [19] 0 0
baseline through Day 85
Secondary outcome [20] 0 0
change in glucagon
Timepoint [20] 0 0
baseline through Day 85
Secondary outcome [21] 0 0
change in homeostatic model assessment index of insulin resistance (HOMA-IR) and homeostatic model assessment index of beta-cell function (HOMA-B)
Timepoint [21] 0 0
baseline through Day 85
Secondary outcome [22] 0 0
change in Partial area glucose level versus time curve from time 0 to 4 hours (?AUC0-4h)
Timepoint [22] 0 0
baseline through Day 85
Secondary outcome [23] 0 0
change in Partial area insulin level versus time curve from time 0 to 4 hours (?AUC0-4h)
Timepoint [23] 0 0
baseline through Day 85
Secondary outcome [24] 0 0
change in Partial area C-peptide level versus time curve from time 0 to 4 hours (?AUC0-4h)
Timepoint [24] 0 0
baseline through Day 85
Secondary outcome [25] 0 0
change in Partial area glucagon level versus time curve from time 0 to 4 hours (?AUC0-4h)
Timepoint [25] 0 0
baseline through Day 85
Secondary outcome [26] 0 0
change percentage of time spent of glucose in target range 3.9 to 10 mmol/L (TIR), time above target range (TAR), time below target range (TBR), 24-hour mean glucose, and glucose variability
Timepoint [26] 0 0
baseline through Day 85
Secondary outcome [27] 0 0
change in hepatic fat fraction measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF ) in part 2
Timepoint [27] 0 0
baseline through Day 85
Secondary outcome [28] 0 0
Change in liver stiffness by FibroScan in subjects with baseline hepatic fat of at least 8%
Timepoint [28] 0 0
baseline through Day 85
Secondary outcome [29] 0 0
Change in the liver function parameters (ALT, AST, alkaline phosphatase (ALP), and gamma-glutamyltransferase (GGT))
Timepoint [29] 0 0
baseline through Day 85
Secondary outcome [30] 0 0
Change in Fibrosis 4 score (FIB-4) and non-alcoholic fatty liver disease fibrosis score (NFS)
Timepoint [30] 0 0
baseline through Day 85

Eligibility
Key inclusion criteria
1. 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.
2. 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.

Male subjects with female partners of childbearing potential are eligible to participate if they are vasectomized, or agree to total abstinence from heterosexual intercourse, from screening through until at least 30 days after the last study dose, or use of an effective method of birth control listed above, from screening through until at least 30 days after the last study dose. Male subjects must refrain from 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 subjects cohort.

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), at screening.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. 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.
2. 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.
3. The subject has a history of chronic pancreatitis or episode of acute pancreatitis within 3 months of screening.
4. 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.
5. The subject has consumed alcohol within 48 hours before dosing or during the confinement period.
6. The subject is a smoker or has used tobacco, nicotine, or nicotine-containing products.
7. The subject has a history of alcohol abuse or drug addiction within the last year or excessive alcohol consumption.
8. 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.
9. The subject is involved in strenuous activity or contact sports within 48 hours before admission.
10. The subject has donated blood or blood products >450 mL within 30 days before the first dose of study drug.
11. The subject has total cholesterol >10.3 mmol/L or triglycerides =5.7 mmol/L (500 mg/dL) at screening.
12. The subject has clinically significant history or presence of ECG findings as determined 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 (if assessed as clinically significant by the investigator), or severe peripheral arterial circulatory disorders.
13. The subject has a history of relevant drug and/or food allergies (ie, allergy to DR10624 or excipients, or any significant food allergy that could preclude a standard diet in the clinical unit).
14. The subject has a history of severe allergic or anaphylactic reactions.
15. The subject has experienced a >5% loss in body weight within 2 months prior to screening.
16. Female subjects who are pregnant or lactating.
17. 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 acid amplification, or polymerase chain reaction (PCR) coronavirus disease-2019 (COVID-19) test during screening or at admission is acceptable provided the subject has a known previous COVID-19 infection =3 weeks prior to dosing, has recovered, and is now asymptomatic
18. The subject has received study drug in another investigational study within 30 days of dosing.
19. In the opinion of the investigator, the subject is not suitable for entry into the study.

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-like peptide-1 receptor agonist (GLP-1Ra), dipeptidyl peptidase-4 inhibitors (DPP-4i), or insulin, within 30 days prior to screening until the follow-up visit.
4. The subjects have >2 × upper limit of normal (ULN) of either alanine aminotransferase (ALT) or aspartate aminotransferase (AST), or >1.5 × ULN for bilirubin or alkaline phosphatase at screening.
5. Subjects with contraindications to MRI.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
104
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Canterbury

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Zhejiang Doer Biologics Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Alexandra Cole, DHPharm
Address 0 0
New Zealand Clinical Research (NZCR)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Senior Clinical Operations Director
Address 0 0
Country 0 0
Phone 0 0
+86 151 94 40 28 68
Fax 0 0
Email 0 0
yg@doerbio.com
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05378893