Trials Sponsors Conditions Drugs Pricing

Conditions

Healthy, Obesity, Metabolically

Outcome Measures

Primary Outcomes (1)

Assess the Safety and Tolerability
Area under the serum concentration-time curve (AUC). For Part 1 and Part 3, AUC from time 0 to infinity (AUC0-inf) is presented. For Part 2, AUC over the dosing interval (AUC0-tau) assessed from pre-dose on Day 78 to 168 hours post-dose is presented. Data presented are from baseline through Day 29 (Part 1 and Part 3) and from pre-final dose on Day 78 through Day 106 (Part 2)
Baseline through Day 29 (Part 1 & Part 3); Pre-final dose on Day 78 through Day 106 (Part 2)

Secondary Outcomes (30)

Area Under the Serum Concentration Versus Time Curve (AUC)
baseline through day 29 (part 1and part 3)or day 106 (part 2)
Maximum Observed Serum Concentration (Cmax)
baseline through day 29 (part 1and part 3) or day 106 (part 2)
Time to Reach Maximum Observed Serum Concentration (Tmax)
baseline through day 29 (part 1and part 3) or day 106 (part 2).
Terminal Elimination Half-life (t1/2)
baseline through day 29 (part 1and part 3) or day 106 (part 2).
Apparent Clearance After Extravascular Administration (CL/F)
baseline through day 29 (part 1and part 3) or day 106 (part 2)
+25 more secondary outcomes

Study Arms (6)

Single-ascending dose：Part1：DR10624

EXPERIMENTAL

Escalating doses of DR10624 for injection administered subcutaneously in healthy participants or obese but otherwise healthy participants

Drug: DR10624 for injection

Single-ascending dose：Part1：placebo

PLACEBO COMPARATOR

Escalating doses of placebo for injection administered subcutaneously in in healthy participants or obese but otherwise healthy participants

Drug: Placebo

Multiple-ascending dose：Part2：DR10624

EXPERIMENTAL

Escalating doses of DR10624 for injection administered subcutaneously in obese adult subjects with moderate hypertriglyceridemia

Interventions

DR10624 for injectionDrug

administered via subcutaneous injection

Multiple-ascending dose：Part2：DR10624Single-ascending dose：Part1：DR10624Single-ascending dose：Part3：DR10624

PlaceboDrug

administered via subcutaneous injection

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

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.

Sponsors & Collaborators

Zhejiang Doer Biologics Co., Ltd.
Industrylead

Study Sites (1)

New Zealand Clinical Research

Christchurch, Canterbury, 8011, New Zealand

MeSH Terms

Conditions

Obesity, Metabolically Benign

Interventions

Injections

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Results Point of Contact

Title: Chief Operating Officer
Organization: Zhejiang Doer Biologics Co., Ltd.

Study Officials

Alexandra Cole, DHPharm
New Zealand Clinical Research (NZCR)
PRINCIPAL INVESTIGATOR
Yanshan Huang, PhD
Zhejiang Doer Biologics Co., Ltd.
STUDY CHAIR
Yongliang Fang, PhD
Zhejiang Doer Biologics Co., Ltd.
STUDY DIRECTOR
Junfang Xu, MD
Huadong Medicine Co., Ltd.
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

153 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

March 25, 2022

First Posted

May 18, 2022

Study Start

June 22, 2022

Actual (reported)

You may not qualify if:

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.
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.
The subject is involved in strenuous activity or contact sports within 48 hours before admission.
The subject has donated blood or blood products \>450 mL within 30 days before the first dose of study drug.
The subject has total cholesterol \>10.3 mmol/L or triglycerides ≥5.7 mmol/L (500 mg/dL) at screening.
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.
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).
The subject has a history of severe allergic or anaphylactic reactions.
+10 more criteria

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (30)

Study Arms (6)

Single-ascending dose：Part1：DR10624

Single-ascending dose：Part1：placebo

Multiple-ascending dose：Part2：DR10624

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Multiple-ascending dose：Part2：placebo

Single-ascending dose：Part3：DR10624

Single-ascending dose：Part3：placebo

You may not qualify if:

Source record

Documents

Locations